Postmarket Study of an Intraocular Lens Power Selection System

Alcon

Status: Completed

Conditions: Cataract

Treatments: Other: Alcon Barrett Toric Calculator; Device: ORA with VerifEye+; Device: Acrysof® IQ Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03579433

ILX369-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

ORA with VerifEye+

Experimental group

Description:

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.

Treatment:

Device: Acrysof® IQ Toric IOL

Device: ORA with VerifEye+

Barrett Toric Calculator

Active Comparator group

Description:

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.

Treatment:

Device: Acrysof® IQ Toric IOL

Other: Alcon Barrett Toric Calculator