Contralateral ReSTOR / Monofocal or Phakic Eye

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Device: ReSTOR

• Registration Number: NCT00731640
• Lead Sponsor: Alcon Research

Brief Summary

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2008-05
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Results First Submitted: 2009-09-09
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-04
• Results First Posted: 2010-03-16
• Last Update Submitted: 2010-03-19
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Unilateral operable cataract
• Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria

• Ocular comorbidities compromising primary outcome
• Bilateral cataracts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monofocal	ReSTOR	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye
Phakic	ReSTOR	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Primary Outcome Measures

Name	Time	Method
Visual Acuity	6 months	Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Contrast Sensitivity	6 Months	Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Patient Satisfaction	6 Months Postoperative	Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Spectacle Independence	6 Months	The percentage of patients reporting spectacle independence (no longer needing to wear glasses).

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States