N/A Completed N=104 Randomized Treatment

Postmarket Study of an Intraocular Lens Power Selection System

Cataract

Source: ClinicalTrials.gov NCT03579433 ↗

Enrolled (actual)

104

Serious AEs

1.2%

Results posted

Apr 2020

Primary outcomePrimary: 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

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.

Outcome Measures

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

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. Informational only — not medical advice.