A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

NCT01684007 | Completed Results

• 1 other identifier: M-12-007
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.

Conditions

Cataracts

Keywords

Intraocular lens; Multifocal intraocular lens (MIOL)

Outcome Measures

Primary Outcomes (1)

• Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)

  Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.

  Day 90 from second eye implantation

Secondary Outcomes (1)

• Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)

  Day 90 from second eye implantation

Study Arms (2)

Bilateral

EXPERIMENTAL

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\], bilateral implantation

Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Contralateral

ACTIVE COMPARATOR

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation

Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Interventions

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] DEVICE

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

Bilateral; Contralateral

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

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

Contralateral

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 informed consent, and attend postoperative examinations per protocol schedule;
• Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
• Willing to have second eye surgery within 45 days of first eye surgery;
• Expected postoperative astigmatism \< 1.0 D in both eyes, as measured by keratometry;
• Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;

You may not qualify if:

• Significant irregular corneal astigmatism as demonstrated by corneal topography;
• Severe degenerative visual disorders;
• Previous corneal surgery;
• Amblyopia;
• Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;
• History of corneal disease;
• Severe diabetic retinopathy;
• History of retinal detachment;
• Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;
• Pregnant or planning pregnancy during course of study;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Magda Michna, Expert Clinical Lead, Surgical
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Magda Michna, PhD

  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: September 10, 2012
• First Posted: September 12, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 22, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-05