Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

NCT01290068 | Completed Results

• 1 other identifier: RDG-10-269
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.

Conditions

Cataract

Keywords

Intraocular Lens

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Classified as Responders

  Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.

  Month 6 after second eye implantation

• Proportion of Participants Reporting Spectacle Independence at All Distances

  Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.

  Month 6 after second eye implantation

• Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)

  Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.

  Month 6 after second eye implantation

Secondary Outcomes (1)

• Median Total Spectacle Cost Prior to Any Reimbursement

  Month 6 after second eye implantation

Study Arms (3)

ReSTOR +3

EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL

ReSTOR +3 Toric

EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Monofocal

ACTIVE COMPARATOR

Monofocal IOL, bilateral implantation

Device: Monofocal IOL

Interventions

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL DEVICE

Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

Also known as: SN6AD1

ReSTOR +3; ReSTOR +3 Toric

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL DEVICE

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Also known as: SND1T2, SND1T3, SND1T4, SND1T5

ReSTOR +3 Toric

Monofocal IOL DEVICE

Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Monofocal

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand and sign an Informed Consent;
• Willing and able to attend post-operative examinations as per protocol schedule;
• Diagnosis of bilateral, age-related cataracts;
• Planned cataract removal via phacoemulsification with implantation of an IOL;
• Available to undergo second eye surgery within 6 weeks of the first eye surgery;
• Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
• No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
• Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
• Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.

You may not qualify if:

• Previous corneal surgery and/or reshaping;
• Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
• Pregnant, lactating, or planning pregnancy during the course of study;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Brand Lead, Surgical, Global Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Brand Lead, Surgical, Global Medical Affairs

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 4, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 2, 2018
• Results First Posted: March 6, 2017

Record last verified: 2017-03