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CompletedNCT01122576Updated Mar 28, 2014Results posted

Evaluation of 3 Intraocular Lenses Following Lens Extraction

A Phase 4 interventional study of Crystalens AO and ReSTOR in Cataract, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-03-28.

Sponsored by Bausch & Lomb Incorporated · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.

02

Conditions studied

  • Cataract

Browse trials for

Keywords

  • Intra Ocular Lens
  • Ocular surgery
  • Phacoemulsification
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 78 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
  • Subjects must require a spherical lens power from 10.00 D to 33.00 D
  • Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion criteria

Exclusion Criteria:

  • Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
  • Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
  • Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Crystalens AO

    Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally.

    Device: Crystalens AO

  • Active comparator
    ReSTOR

    Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.

    Device: ReSTOR

  • Active comparator
    Tecnis Multifocal IOL

    Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.

    Device: Tecnis Multifocal IOL

Interventions

  • DeviceCrystalens AO

    Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.

  • DeviceReSTOR

    ReSTOR surgically implanted bilaterally. Study observation up to 180 days.

  • DeviceTecnis Multifocal IOL

    Tecnis surgically implanted bilaterally. Study observation up to 180 days.

06

What researchers measure

Primary outcomes

  1. Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 3 (2-3 months)

  2. Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 3 (2-3 months)

  3. Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 3 (2-3 months)

  4. Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 3 (2-3 months)

  5. Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 4 ( 4-6 months)

  6. Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 4 ( 4-6 months)

  7. Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 4 ( 4-6 months)

  8. Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 4 ( 4-6 months)

  9. Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Postoperative visit 4 ( 4-6 months)

Secondary outcomes

  1. Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  2. Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  3. Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  4. Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  5. Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  6. Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  7. Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  8. Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  9. Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  10. Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  11. Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  12. Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  13. Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  14. Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  15. Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  16. Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  17. Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  18. Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  19. Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  20. Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  21. Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 3 (2-3 months)

  22. Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  23. Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  24. Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  25. Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree

    Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

    Time frame: Visit 4 (4-6 months)

  26. Optical Scatter

    Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.

    Time frame: Visit 3 (2-3 months)

  27. Optical Scatter

    Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.

    Time frame: Visit 4 (4-6 months)

  28. Monocular Halo and Starburst

    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

    Time frame: Visit 3 (2-3 months)

  29. Monocular Halo and Starburst

    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

    Time frame: Visit 4 (4-6 months)

  30. Binocular Halo and Starburst

    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

    Time frame: Visit 3 (2-3 months)

  31. Binocular Halo and Starburst

    Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

    Time frame: Visit 4 (4-6 months)

  32. Manifest Refraction

    Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

    Time frame: Visit 3 (2-3 Months)

  33. Manifest Refraction

    Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

    Time frame: Visit 4 (4-6 Months)

  34. Uncorrected Distance Visual Acuity

    High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches

    Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)

  35. Best-corrected Distance Visual Acuity

    High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)

    Time frame: Visit 3 (2-3 months) Visit 4 (4-6 months)

07

Results

Posted Mar 28, 2014

Participant flow

This study took place at two investigative sites in the United States, with the first participant undergoing cataract surgery on 5/18/2010 and last participant completed the study on 6/27/2012.

Pre-Cataract Surgery
Participant flow — Pre-Cataract Surgery
MilestoneCrystalens AOReSTORTecnis Multifocal IOL
Started262626
Completed262524
Not completed012
Withdrew: Withdrawal by subject012
Post-Cataract Surgery
Participant flow — Post-Cataract Surgery
MilestoneCrystalens AOReSTORTecnis Multifocal IOL
Started262524
Completed262522
Not completed002
Withdrew: Central macular edema001
Withdrew: Fellow eye explanted001

Outcome measures

PrimaryMesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
1.5 cycles/degree1.494 ± 0.1731.576 ± 0.2091.410 ± 0.195
3 cycles/degree1.613 ± 0.1711.679 ± 0.1991.528 ± 0.175
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree1.563 ± 0.2281.644 ± 0.2531.481 ± 0.212
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree1.155 ± 0.2381.335 ± 0.3091.143 ± 0.189
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree0.943 ± 0.2660.950 ± 0.2970.697 ± 0.138
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 4 ( 4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree1.525 ± 0.2031.588 ± 0.2131.408 ± 0.172
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 4 ( 4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree1.638 ± 0.2431.698 ± 0.2211.519 ± 0.125
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 4 ( 4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree1.610 ± 0.2411.622 ± 0.2281.543 ± 0.261
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 4 ( 4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree1.229 ± 0.2621.218 ± 0.2381.217 ± 0.275
PrimaryMesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Postoperative visit 4 ( 4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree0.998 ± 0.2970.789 ± 0.2190.896 ± 0.275
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
1.5 cycles/degree1.688 ± 0.2211.749 ± 0.2011.537 ± 0.129
3 cycles/degree1.775 ± 0.2521.797 ± 0.2131.667 ± 0.168
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree1.731 ± 0.2131.677 ± 0.2571.593 ± 0.225
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree1.189 ± 0.1701.362 ± 0.3231.153 ± 0.228
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree0.965 ± 0.2580.994 ± 0.3590.861 ± 0.241
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
1.5 cycles/degree1.712 ± 0.2121.743 ± 0.2181.537 ± 0.147
3 cycles/degree1.785 ± 0.2231.768 ± 0.2431.594 ± 0.135
6 cycles/degree1.710 ± 0.2341.682 ± 0.2681.595 ± 0.265
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree1.261 ± 0.2911.273 ± 0.2691.235 ± 0.245
SecondaryBinocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree1.160 ± 0.3561.008 ± 0.3860.885 ± 0.287
SecondaryMesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree1.329 ± 0.1721.389 ± 0.2191.233 ± 0.182
SecondaryMesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree1.527 ± 0.1901.518 ± 0.2671.388 ± 0.245
SecondaryMesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree1.514 ± 0.2171.504 ± 0.3131.397 ± 0.265
SecondaryMesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree1.118 ± 0.2251.192 ± 0.2351.059 ± 0.208
SecondaryMesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree0.883 ± 0.1990.989 ± 0.3360.903 ± 0
SecondaryMesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree1.343 ± 0.2541.367 ± 0.2291.199 ± 0.145
SecondaryMesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree1.536 ± 0.2471.462 ± 0.2121.367 ± 0.196
SecondaryMesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree1.535 ± 0.2741.475 ± 0.2761.413 ± 0.265
SecondaryMesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree1.341 ± 0.3411.272 ± 0.3581.190 ± 0.327
SecondaryMesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree1.139 ± 0.3151.192 ± 0.3340.849 ± 0.353
SecondaryMesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
1.5 cycles/degree1.459 ± 0.2391.439 ± 0.2161.316 ± 0.210
3 cycles/degree1.609 ± 0.1891.492 ± 0.2641.405 ± 0.225
SecondaryMesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree1.574 ± 0.1831.496 ± 0.3851.412 ± 0.261
SecondaryMesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree1.199 ± 0.2431.337 ± 0.2731.141 ± 0.222
SecondaryMesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree0.980 ± 0.2951.009 ± 0.0960.690 ± 0.125
SecondaryMesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
1.5 cycles/degree1.392 ± 0.2221.404 ± 0.2381.344 ± 0.151
3 cycles/degree1.573 ± 0.2681.493 ± 0.3041.410 ± 0.223
SecondaryMesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree1.519 ± 0.2961.515 ± 0.3301.448 ± 0.271
SecondaryMesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree1.321 ± 0.3311.319 ± 0.4501.337 ± 0.419
SecondaryMesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree

Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · log contrast sensitivity units
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
log contrast sensitivity unitsCrystalens AOReSTORTecnis Multifocal IOL
Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree1.175 ± 0.2581.101 ± 0.4391.060 ± 0.648
SecondaryOptical Scatter

Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · units on a scale
Optical Scatter
units on a scaleCrystalens AOReSTORTecnis Multifocal IOL
Optical Scatter1.1280 ± 0.76611.8080 ± 0.86851.9179 ± 0.9751
SecondaryOptical Scatter

Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · units on a scale
Optical Scatter
units on a scaleCrystalens AOReSTORTecnis Multifocal IOL
Optical Scatter1.1308 ± 0.73371.9760 ± 1.16301.8318 ± 0.9840
SecondaryMonocular Halo and Starburst

Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · units on a scale
Monocular Halo and Starburst
units on a scaleCrystalens AOReSTORTecnis Multifocal IOL
Halo1.2 ± 0.91.3 ± 0.81.8 ± 0.9
Starburst4.5 ± 1.14.7 ± 1.04.5 ± 1.2
SecondaryMonocular Halo and Starburst

Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · units on a scale
Monocular Halo and Starburst
units on a scaleCrystalens AOReSTORTecnis Multifocal IOL
Halo1.2 ± 0.61.5 ± 0.81.8 ± 0.7
Starburst4.6 ± 1.04.7 ± 1.04.5 ± 1.2
SecondaryBinocular Halo and Starburst

Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

Time frame:
Visit 3 (2-3 months)
Reported as:
Mean · units on a scale
Binocular Halo and Starburst
units on a scaleCrystalens AOReSTORTecnis Multifocal IOL
Halo1.2 ± 1.11.4 ± 0.82.0 ± 1.0
Starburst4.6 ± 1.14.7 ± 1.04.6 ± 0.9
SecondaryBinocular Halo and Starburst

Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.

Time frame:
Visit 4 (4-6 months)
Reported as:
Mean · units on a scale
Binocular Halo and Starburst
units on a scaleCrystalens AOReSTORTecnis Multifocal IOL
Halo1.3 ± 0.71.8 ± 1.22.0 ± 0.9
Starburst4.6 ± 1.04.9 ± 0.44.5 ± 0.9
SecondaryManifest Refraction

Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

Time frame:
Visit 3 (2-3 Months)
Reported as:
Mean · Diopters
Manifest Refraction
DioptersCrystalens AOReSTORTecnis Multifocal IOL
Manifest Refraction-0.507 ± 0.4330.038 ± 0.344-0.114 ± 0.362
SecondaryManifest Refraction

Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.

Time frame:
Visit 4 (4-6 Months)
Reported as:
Mean · Diopters
Manifest Refraction
DioptersCrystalens AOReSTORTecnis Multifocal IOL
Manifest Refraction-0.339 ± 0.4550.145 ± 0.370-0.091 ± 0.339
SecondaryUncorrected Distance Visual Acuity

High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches

Time frame:
Visit 3 (2-3 months) Visit 4 (4-6 months)
Reported as:
Mean · logMAR
Uncorrected Distance Visual Acuity
logMARCrystalens AOReSTORTecnis Multifocal IOL
UCDVA Monocular Visit 30.122 ± 0.1710.002 ± 0.1150.072 ± 0.150
UCDVA Monocular Visit 40.113 ± 0.1730.016 ± 0.1210.060 ± 0.148
UCDVA Binocular Visit 30.005 ± 0.082-0.054 ± 0.102-0.048 ± 0.087
UCDVA Binocular Visit 4-0.026 ± 0.110-0.061 ± 0.080-0.053 ± 0.104
UCIVA Monocular Visit 30.055 ± 0.1590.219 ± 0.1500.237 ± 0.221
UCIVA Monocular Visit 40.066 ± 0.1680.244 ± 0.1580.237 ± 0.197
UCIVA Binocular Visit 3-0.012 ± 0.1300.138 ± 0.1400.126 ± 0.169
UCIVA Binocular Visit 4-0.024 ± 0.1110.169 ± 0.1440.175 ± 0.146
UCNVA Monocular Visit 30.192 ± 0.1890.005 ± 0.1080.164 ± 0.149
UCNVA Monocular Visit 40.264 ± 0.195-0.008 ± 0.1200.188 ± 0.185
UCNVA Binocular Visit 30.082 ± 0.151-0.057 ± 0.0740.041 ± 0.109
UCNVA Binocular Visit 40.133 ± 0.148-0.061 ± 0.0870.043 ± 0.130
SecondaryBest-corrected Distance Visual Acuity

High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)

Time frame:
Visit 3 (2-3 months) Visit 4 (4-6 months)
Reported as:
Mean · logMAR
Best-corrected Distance Visual Acuity
logMARCrystalens AOReSTORTecnis Multifocal IOL
BCDVA Monocular Visit 3-0.100 ± 0.070-0.094 ± 0.080-0.068 ± 0.098
BCDVA Monocular Visit 4-0.100 ± 0.066-0.096 ± 0.106-0.075 ± 0.088
BCDVA Binocular Visit 3-0.144 ± 0.049-0.133 ± 0.0730.115 ± 0.057
BCDVA Binocular Visit 4-0.136 ± 0.049-0.137 ± 0.058-0.117 ± 0.098
DCIVA Monocular Visit 30.169 ± 0.1440.292 ± 0.1320.292 ± 0.162
DCIVA Monocular Visit 40.186 ± 0.1290.297 ± 0.1190.328 ± 0.159
DCIVA Binocular Visit 30.095 ± 0.1460.222 ± 0.1120.196 ± 0.112
DCIVA Binocular Visit 40.084 ± 0.1090.229 ± 0.1080.229 ± 0.127
DCNVA Monocular Visit 30.346 ± 0.130-0.004 ± 0.0870.132 ± 0.143
DCNVA Monocular Visit 40.360 ± 0.144-0.042 ± 0.1320.136 ± 0.144
DCNVA Binocular Visit 30.261 ± 0.109-0.079 ± 0.065-0.004 ± 0.100
DCNVA Binocular Visit 40.247 ± 0.126-0.075 ± 0.0960.025 ± 0.127

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Crystalens AO—0/26 (0%)10/52 (19.2%)
ReSTOR—1/25 (4%)13/50 (26%)
Tecnis Multifocal IOL—3/23 (13%)4/46 (8.7%)
Most frequent serious events
Most frequent serious events
EventCrystalens AOReSTORTecnis Multifocal IOL
Vitreous hemorrhageEye disorders0/260/251/23
Pulmonary embolismVascular disorders0/260/251/23
PyelonephritisRenal and urinary disorders0/260/251/23
Retinal vein occlusionEye disorders0/261/250/23
Most frequent other events
Most frequent other events
EventCrystalens AOReSTORTecnis Multifocal IOL
Punctate KeratitisEye disorders8/521/502/46
Increased Intraocular Pressure (IOP)Eye disorders0/527/500/46
Corneal EdemaEye disorders2/525/502/46

Baseline characteristics

Age, Customized
Age, Customized(participants)Crystalens AOReSTORTecnis Multifocal IOLTotal
<40 years0000
40 - 49 years0112
50-59 years105823
60-69 years13121237
70-79 years38415
≥ 800011
Sex: Female, Male
Sex: Female, Male(Participants)Crystalens AOReSTORTecnis Multifocal IOLTotal
Female17151951
Male911727
Region of Enrollment
Region of Enrollment(participants)Crystalens AOReSTORTecnis Multifocal IOLTotal
United States26262678
08

Study locations

1 site
  • Bausch & Lomb, Inc
    Aliso Viejo, California 92656, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01122576
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
May 13, 2010
Start date
Jun 2010
Primary completion
Jun 2012
Completion
Sep 2012
Results posted
Mar 28, 2014
Last update
Mar 28, 2014

Study contacts

Omid Khodai, OD, RAC
study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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