Presbyopia-Correcting Intraocular Lenses (IOLs)

Phase 4

Completed

• Conditions: Cataract

• Registration Number: NCT00963560
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2011-03
• Status Verified: 2011-07
• Results First Submitted: 2011-07-13
• Results First Submitted QC: 2011-07-13
• Last Update Submitted: 2011-07-13
• Results First Posted: 2011-08-09
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• diagnosed with bilateral cataracts
• candidate for presbyopic lens

Exclusion Criteria

• > 1 Diopter preoperative astigmatism by Keratometry readings
• pre-existing conditions that could skew the results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	6 Months after surgery	Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

Trial Locations

Locations (1)

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