CClinicalTrials.gg
Sign In
CompletedNCT00684138Updated Jul 13, 2010Results posted

ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

A Phase 4 interventional study of ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens and ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens in Cataract, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2010-07-13.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.

02

Conditions studied

  • Cataract

Browse trials for

Keywords

  • cataract
  • cataract surgery
  • IOL
  • intraocular lens
  • ReSTOR
  • Replacement of cataract
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 300 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts
  • Calculated lens power is within the available range
  • Willing and able to complete all required postoperative visits
  • Planned cataract removal by phacoemulsification and/or liquifacture
  • Potential postoperative visual acuity of 0.2 logMAR or better in study eyes
  • Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes
  • Clear intraocular media other than cataract in study eyes
  • Able to comprehend and sign a statement of informed consent
  • Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse than 0.2 logMAR

Exclusion criteria

Exclusion:

  • Significant irregular corneal aberration as demonstrated by corneal topography
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR
  • Subjects who may reasonably be expected to require laser treatments at any time
  • Previous corneal refractive surgery
  • Amblyopia
  • Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
  • Diabetic retinopathy
  • Extremely shallow anterior chamber, not due to swollen cataract
  • Microphthalmos
  • Previous retinal detachment
  • Previous corneal transplant
  • Recurrent severe anterior or posterior segment inflammation of unknown etiology
  • Rubella or traumatic cataract
  • Iris neovascularization
  • Glaucoma (uncontrolled or controlled with medication)
  • Aniridia
  • Optic nerve atrophy
  • Pregnancy
  • Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®)
  • Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    ReSTOR Aspheric +3.0D

    ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

    Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

  • Active comparator
    ReSTOR Aspheric +4.0D

    ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

    Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

Interventions

  • DeviceACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens

    Intraocular Lens

  • DeviceACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

    Intraocular Lens

06

What researchers measure

Primary outcomes

  1. Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)

    Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

    Time frame: 3 months

Secondary outcomes

  1. Binocular Distance Corrected Distance Visual Acuity

    Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

    Time frame: 3 months post-operative

  2. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)

    Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

    Time frame: 3 months post-operative

  3. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)

    Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

    Time frame: 3 months post-operative

  4. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)

    Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

    Time frame: 3 months post-operative

07

Results

Posted Mar 11, 2010
Limitations and caveats
Data from one investigator, who implanted 20 subjects, were excluded from analysis due to non compliance with data collection and documentation. This resulted in 280 implanted subjects that were considered evaluable.

Participant flow

Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.

Participant flow — Overall Study
MilestoneACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Started141139
Completed138131
Not completed38

Outcome measures

PrimaryBinocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)

Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

Time frame:
3 months
Reported as:
Mean · logMAR
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
logMARACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)0.07 (0.0539 to 0.0854)0.09 (0.0854 to 0.1081)
SecondaryBinocular Distance Corrected Distance Visual Acuity

Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Time frame:
3 months post-operative
Reported as:
Mean · logMAR
Binocular Distance Corrected Distance Visual Acuity
logMARACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Binocular Distance Corrected Distance Visual Acuity-0.05 (-0.065 to -0.040)-0.05 (-0.061 to -0.039)
SecondaryBinocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)

Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Time frame:
3 months post-operative
Reported as:
Mean · logMAR
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
logMARACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)0.06 (0.0384 to 0.0849)0.24 (0.2188 to 0.2667)
SecondaryBinocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)

Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Time frame:
3 months post-operative
Reported as:
Mean · logMAR
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
logMARACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)0.12 (0.0916 to 0.1381)0.32 (0.2972 to 0.3451)
SecondaryBinocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)

Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Time frame:
3 months post-operative
Reported as:
Mean · logMAR
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
logMARACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)0.18 (0.1597 to 0.2062)0.34 (0.3190 to 0.3669)

Adverse events

Collected over Up to six months after cataract surgery.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ACRYSOF® ReSTOR® +3.0 (First Eyes)—6/153 (3.9%)0/153 (0%)
ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)—2/147 (1.4%)0/147 (0%)
ACRYSOF® ReSTOR® +3.0 (Second Eyes)—2/151 (1.3%)0/151 (0%)
ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)—3/143 (2.1%)0/143 (0%)
Most frequent serious events
Most frequent serious events
EventACRYSOF® ReSTOR® +3.0 (First Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)ACRYSOF® ReSTOR® +3.0 (Second Eyes)ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
Macular EdemaEye disorders4/1532/1470/1511/143
Surgical reintervention (SI)Surgical and medical procedures2/1531/1472/1512/143
HypopyonEye disorders1/1530/1470/1510/143
EndophthalmitisEye disorders1/1530/1470/1510/143
Lens DislocationEye disorders1/1530/1470/1510/143

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0Total
<=18 years000
Between 18 and 65 years514091
>=65 years9099189
Sex: Female, Male
Sex: Female, Male(Participants)ACRYSOF® ReSTOR® +3.0ACRYSOF® ReSTOR® Aspheric +4.0Total
Female9597192
Male464288
08

Study locations

1 site
  • Call Center for Locations
    Fort Worth, Texas 76134, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00684138
Lead sponsor
Alcon Research
First posted
May 26, 2008
Start date
Jun 2007
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Mar 11, 2010
Last update
Jul 13, 2010

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cataract→

Other studies from this sponsor

Alcon Research

Start the discussion