MedPath

Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

Phase 4
Completed
Conditions
Cataracts
Interventions
Device: AcrySof ReSTOR Aspheric IOL
Registration Number
NCT00818116
Lead Sponsor
Alcon Research
Brief Summary

The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
Inclusion Criteria
  • Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.
  • 50~75 years of age
  • <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.
Exclusion Criteria
  • Patients with pre-existing conditions that could skew the results.
  • Any of conditions before and during surgery specified in the product information.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ReSTOR Aspheric IOLAcrySof ReSTOR Aspheric IOLBilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Primary Outcome Measures
NameTimeMethod
Uncorrected and Best Corrected Visual Acuities (Near and Distance)6 Months Following Cataract Surgery

Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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
NameTimeMethod

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations

🇺🇸

Fort Worth, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath