A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

NCT ID: NCT01257217

Last Updated: 2018-07-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Detailed Description

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Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ReSTOR +3

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation

Group Type EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Intervention Type DEVICE

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

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT

Intervention Type DEVICE

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

Acri.LISA

Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation

Group Type ACTIVE_COMPARATOR

Acri.LISA® 366D IOL

Intervention Type DEVICE

Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient

Acri.LISA® 466TD Toric IOL

Intervention Type DEVICE

Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Interventions

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AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

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

Intervention Type DEVICE

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT

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

Intervention Type DEVICE

Acri.LISA® 366D IOL

Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient

Intervention Type DEVICE

Acri.LISA® 466TD Toric IOL

Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Intervention Type DEVICE

Other Intervention Names

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Models SND1T2, SND1T3, SND1T4, SND1T5, SND1T6

Eligibility Criteria

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Inclusion Criteria

* Sign informed consent;
* Able to attend postoperative examinations per protocol schedule;
* Diagnosed with bilateral cataracts;
* Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
* Preoperative astigmatism ≤ 2.5 diopter;
* Good ocular health, with the exception of cataracts;
* Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
* Able to undergo second eye surgery within one month of the first eye surgery;

Exclusion Criteria

* Previous corneal surgery;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Any ocular disease and/or condition that may compromise study results;
* Pregnant or planning pregnancy during course of study;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Diabetic retinopathy;
* Macular degeneration;
* History of retinal detachment;
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brand Lead, Surgical, Global Medical Affairs

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

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M09-051

Identifier Type: -

Identifier Source: org_study_id

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