Contralateral ReSTOR / Monofocal or Phakic Eye

Phase 4CompletedNCT00731640

Alcon Research52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataracts

Interventions

ReSTORDEVICE

AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Unilateral operable cataract * Candidate for presbyopic intraocular lens (IOL) Exclusion Criteria: * Ocular comorbidities compromising primary outcome * Bilateral cataracts

Locations (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Visual Acuity

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.

Time frame: 6 months

Secondary Outcomes

Contrast Sensitivity

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.

Time frame: 6 Months

Patient Satisfaction

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).

Time frame: 6 Months Postoperative

Spectacle Independence

The percentage of patients reporting spectacle independence (no longer needing to wear glasses).

Time frame: 6 Months

Data from ClinicalTrials.gov

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