Postmarket Study of an Intraocular Lens Power Selection System

Alcon Research124 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Cataract

Interventions

ORA with VerifEye+DEVICE

Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.

Alcon Barrett Toric CalculatorOTHER

Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.

Acrysof® IQ Toric IOLDEVICE

Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (9)

Alcon Investigative Site

Mt. Dora, Florida, United States

Alcon Investigative Site

Panama City, Florida, United States

Alcon Investigative Site

Poughkeepsie, New York, United States

Alcon Investigative Site

Outcomes

Primary Outcomes

Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at 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.

Time frame: Month 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.