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OpenTrials
Completed

NCT Number: NCT01290068

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • 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;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

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

Other names: SN6AD1

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

Other names: SND1T2, SND1T3, SND1T4, SND1T5

Monofocal IOL

Device

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

Primary outcomes

  1. Percentage of Participants Classified as Responders

    Time frame: Month 6 after second eye implantation

    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.

  2. Proportion of Participants Reporting Spectacle Independence at All Distances

    Time frame: Month 6 after second eye implantation

    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.

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

    Time frame: Month 6 after second eye implantation

    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.

Secondary outcomes

  1. Median Total Spectacle Cost Prior to Any Reimbursement

    Time frame: Month 6 after second eye implantation

    Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 4, 2011
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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