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N/A N=104 Randomized Treatment

Postmarket Study of an Intraocular Lens Power Selection System

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT03579433 ↗
Enrolled (actual)
104
Serious AEs
1.2%
Results posted
Apr 2020
Primary outcome: Primary: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6 — 87.1; 87.4 percentage of eyes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ORA with VerifEye+ (Device); Alcon Barrett Toric Calculator (Other); Acrysof® IQ Toric IOL (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Apr 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6		 87.1; 87.4 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03579433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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