Postmarket Study of an Intraocular Lens Power Selection System

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT03579433
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.

Detailed Description

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-06
• Study Start: 2018-08-16
• Primary Completion: 2019-04-16
• Study Completion: 2019-04-16
• Results First Submitted: 2020-03-23
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Results First Posted: 2020-04-07
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Planned cataract surgery with IOL implantation
• Able to comprehend and sign the informed consent form
• Preoperative astigmatism of 0.75 to 3.00 Diopter
• Willing and able to complete all required postoperative visits
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Unclear intraocular media other than cataract
• Pregnant or lactating
• Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6	Month 6	Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Nacogdoches, Texas, United States