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

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ClinicalTrials.gov Identifier: NCT01290068
Recruitment Status : Completed
First Posted : February 4, 2011
Results First Posted : March 6, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Device: Monofocal IOL Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation
Study Start Date : April 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation
 Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Other Name: SN6AD1
Experimental: ReSTOR +3 Toric
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
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Other Name: SN6AD1

Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Other Name: SND1T2, SND1T3, SND1T4, SND1T5
Active Comparator: Monofocal
Monofocal IOL, bilateral implantation
 Device: Monofocal IOL
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290068


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Brand Lead, Surgical, Global Medical Affairs Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01290068    
Other Study ID Numbers: RDG-10-269
First Posted: February 4, 2011    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: July 2, 2018
Last Verified: March 2017
Keywords provided by Alcon Research:
Intraocular Lens
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases