Postmarket Study of an Intraocular Lens Power Selection System

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: ORA with VerifEye+; Other: Alcon Barrett Toric Calculator; Device: Acrysof® IQ Toric IOL

• 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

Arm && Interventions

Group	Intervention	Description
ORA with VerifEye+	Acrysof® IQ Toric IOL	First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
ORA with VerifEye+	ORA with VerifEye+	First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Barrett Toric Calculator	Acrysof® IQ Toric IOL	First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Barrett Toric Calculator	Alcon Barrett Toric Calculator	First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative 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