CClinicalTrials.gg
Sign In
CompletedNCT02691741Updated Sep 27, 2019Results posted

Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

An interventional study of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL and AT LISA® tri IOL in Cataracts, sponsored by Alcon Research. Completed. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Alcon Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Read the detailed description

Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

02

Conditions studied

  • Cataracts
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 215 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
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Calculated lens power between 13.0 and 30.0 Diopters (D);
  • Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
  • Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
  • Preoperative regular corneal astigmatism of \< 1.00 D, in both eyes;
  • Clear intraocular media other than cataract in both eyes;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
  • Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
  • Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
  • Amblyopia;
  • Previous corneal transplant;
  • Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
  • Rubella, congenital, traumatic, or complicated cataracts;
  • Glaucoma (uncontrolled or controlled with medication);
  • Degenerative eye disorders;
  • History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
  • Optic nerve atrophy;
  • Expected to require retinal laser treatment;
  • Color vision deficiencies;
  • Pregnant or lactating (current or planned during the course of the study);
  • Other protocol-specified exclusion criteria may apply.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
215 participants (actual)

Study arms

  • Experimental
    TFNT00

    AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

    Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

  • Active comparator
    839MP

    AT LISA® tri IOL, bilateral implantation

    Device: AT LISA® tri IOL

Interventions

  • DeviceAcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

    Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

    Also known as: Model TFNT00

  • DeviceAT LISA® tri IOL

    Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

    Also known as: Model 839MP

06

What researchers measure

Primary outcomes

  1. Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180

    VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

    Time frame: Day 120-180 from second eye implantation

Secondary outcomes

  1. Least Squares Mean Binocular UCIVA (60cm) at Day 120-180

    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

    Time frame: Day 120-180 from second eye implantation

  2. Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180

    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

    Time frame: Day 120-180 from second eye implantation

  3. Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180

    VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

    Time frame: Day 120-180 from second eye implantation

  4. Mean Photopic Binocular Defocus Curve at Day 120-180

    A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.

    Time frame: Day 120-180 from second eye implantation

  5. Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

    Time frame: Day 120-180 from second eye implantation

  6. Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

    Time frame: Day 120-180 from second eye implantation

  7. Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

    Time frame: Day 120-180 from second eye implantation

  8. Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180

    Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

    Time frame: Day 120-180 from second eye implantation

  9. Subject Satisfaction Recorded at Day 120-180

    At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.

    Time frame: Day 120-180 from second eye implantation

07

Results

Posted Sep 27, 2019

Participant flow

Subjects were recruited from 15 study centers located in Australia (3), Brazil (3), Spain (3), Denmark (2), Colombia (2), United Kingdom (1), and the Netherlands (1).

Participant flow — Overall Study
MilestoneTFNT00839MP
Started9494
All-implanted analysis set9389
Best-case analysis set8685
Safety analysis set9389
Completed9387
Not completed17
Withdrew: Adverse event02
Withdrew: Lost to follow-up10
Withdrew: Physician decision01
Withdrew: Withdrawal by subject04

Outcome measures

PrimaryLeast Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180

VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Least squares mean · logMAR
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
logMARTFNT00839MP
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-1800.053 ± 0.01340.115 ± 0.0139
Statistical analysis
  • TFNT00 vs 839MP · Mean difference (final values): -0.061 · 90% CI -0.093 to -0.029
SecondaryLeast Squares Mean Binocular UCIVA (60cm) at Day 120-180

VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Least squares mean · logMAR
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
logMARTFNT00839MP
Least Squares Mean Binocular UCIVA (60cm) at Day 120-1800.053 ± 0.01340.115 ± 0.0139
Statistical analysis
  • TFNT00 vs 839MP · Repeated Measures Analysis of Variance · p = 0.002 · Mean difference (final values): -0.061 · 90% CI -0.093 to -0.029
SecondaryLeast Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180

VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Least squares mean · logMAR
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
logMARTFNT00839MP
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-1800.015 ± 0.01090.004 ± 0.0113
Statistical analysis
  • TFNT00 vs 839MP · Mean difference (final values): 0.012 · 95% CI -0.019 to 0.043
  • TFNT00 vs 839MP · Repeated Measures Analysis of Variance · p = 0.455
SecondaryLeast Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180

VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Least squares mean · logMAR
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
logMARTFNT00839MP
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-1800.083 ± 0.01160.133 ± 0.0121
Statistical analysis
  • TFNT00 vs 839MP · Mean difference (final values): -0.051 · 90% CI -0.078 to -0.023
  • TFNT00 vs 839MP · Repeated Measures Analysis of Variance · p = 0.003
SecondaryMean Photopic Binocular Defocus Curve at Day 120-180

A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Mean · logMAR
Mean Photopic Binocular Defocus Curve at Day 120-180
logMARTFNT00839MP
0.0 Diopter (D)-0.048 ± 0.0811-0.069 ± 0.0831
-0.5D0.016 ± 0.0835-0.018 ± 0.0951
-1.0D0.093 ± 0.09930.048 ± 0.1207
-1.5D0.038 ± 0.09830.084 ± 0.1111
-2.0D0.011 ± 0.08590.117 ± 0.1039
-2.5D0.027 ± 0.10130.063 ± 0.1399
-3.0D0.118 ± 0.12970.077 ± 0.1241
-3.5D0.231 ± 0.12520.206 ± 0.1415
-4.0D0.338 ± 0.13190.364 ± 0.1302
-4.5D0.469 ± 0.14170.532 ± 0.1240
-5.0D0.586 ± 0.12920.644 ± 0.1048
SecondaryMean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Mean · log units
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
log unitsTFNT00839MP
3 CPD1.720 ± 0.20251.735 ± 0.1894
6 CPD1.860 ± 0.26351.831 ± 0.2699
12 CPD1.482 ± 0.38531.496 ± 0.4328
18 CPD1.021 ± 0.37781.022 ± 0.4197
SecondaryMean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Mean · log units
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
log unitsTFNT00839MP
3 CPD1.721 ± 0.20411.754 ± 0.2225
6 CPD1.790 ± 0.32821.797 ± 0.3538
12 CPD1.434 ± 0.46161.426 ± 0.4570
18 CPD1.007 ± 0.37691.033 ± 0.4316
SecondaryMean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Mean · log units
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
log unitsTFNT00839MP
1.5 CPD1.611 ± 0.22931.600 ± 0.2226
3 CPD1.648 ± 0.31151.682 ± 0.2639
6 CPD1.667 ± 0.42841.676 ± 0.4243
12 CPD1.208 ± 0.52621.227 ± 0.5307
SecondaryMean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180

Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Mean · log units
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
log unitsTFNT00839MP
1.5 CPD1.579 ± 0.25811.538 ± 0.2568
3 CPD1.642 ± 0.26961.682 ± 0.2642
6 CPD1.550 ± 0.47911.607 ± 0.4898
12 CPD1.146 ± 0.56231.175 ± 0.6062
SecondarySubject Satisfaction Recorded at Day 120-180

At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.

Time frame:
Day 120-180 from second eye implantation
Reported as:
Number · percentage of subjects
Subject Satisfaction Recorded at Day 120-180
percentage of subjectsTFNT00839MP
Yes95.796.6
No3.22.3
Missing1.11.1

Adverse events

Collected over IOL implantation through study completion, an average of 7 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TFNT00 - 1st Eye0/93 (0%)0/93 (0%)8/93 (8.6%)
TFNT00 - 2nd Eye0/93 (0%)0/93 (0%)8/93 (8.6%)
TFNT00 - Systemic0/93 (0%)2/93 (2.2%)0/93 (0%)
839MP - 1st Eye0/89 (0%)3/89 (3.4%)7/89 (7.9%)
839MP - 2nd Eye0/87 (0%)2/87 (2.3%)3/87 (3.4%)
839MP - Non-Study Eye0/2 (0%)0/2 (0%)0/2 (0%)
839MP - Systemic0/89 (0%)0/89 (0%)0/89 (0%)
Most frequent serious events
Most frequent serious events
EventTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - Systemic839MP - 1st Eye839MP - 2nd Eye839MP - Non-Study Eye839MP - Systemic
Cystoid macular oedemaEye disorders0/930/930/932/892/870/20/89
Intra-ocular injectionSurgical and medical procedures0/930/930/931/891/870/20/89
Device dislocationProduct Issues0/930/930/931/890/870/20/89
Intraocular lens implantSurgical and medical procedures0/930/930/931/890/870/20/89
NauseaGastrointestinal disorders0/930/931/930/890/870/20/89
Pleural effusionRespiratory, thoracic and mediastinal disorders0/930/931/930/890/870/20/89
Most frequent other events
Most frequent other events
EventTFNT00 - 1st EyeTFNT00 - 2nd EyeTFNT00 - Systemic839MP - 1st Eye839MP - 2nd Eye839MP - Non-Study Eye839MP - Systemic
Posterior capsule opacificationEye disorders3/933/930/935/891/870/20/89
Halo visionEye disorders5/935/930/932/892/870/20/89

Baseline characteristics

All-Implanted Analysis Set

Age, Continuous
Age, Continuous(years)TFNT00839MPTotal
Mean66.1 ± 9.2965.6 ± 9.5665.9 ± 9.40
Sex: Female, Male
Sex: Female, Male(Participants)TFNT00839MPTotal
Female5755112
Male363470
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TFNT00839MPTotal
Race/Ethnicity — White or Caucasian423981
Race/Ethnicity — Black or African American224
Race/Ethnicity — Asian3811
Race/Ethnicity — American Indian or Native American000
Race/Ethnicity — Hawaiian or Other Pacific Islander202
Race/Ethnicity — Multi-Racial022
Race/Ethnicity — Other443882
08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

  • Statistical analysis plan · Jul 12, 2016
  • Study protocol · Feb 24, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02691741
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Feb 25, 2016
Start date
Apr 29, 2016
Primary completion
Jul 17, 2017
Completion
Jul 17, 2017
Results posted
Sep 27, 2019
Last update
Sep 27, 2019

Study contacts

Sr. Clinical Manager, GCRA
study director · Alcon, a Novartis Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. 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