NCT02842151

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery

Optimizing the Assessment of Refractive Outcomes After Cataract Surgery and Implantation of a Monofocal IOL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate current available assessments (automated vs. manual) with which manifest refraction data and biometric variables are obtained to understand if data from an automated refractor can be utilized to optimize the A-constant as well as manual subjective refraction (ie, to a clinically insignificant difference). The A-constant is the calculated number that helps the surgeon determine which IOL should be implanted in the eye during cataract surgery.

Detailed description

Subjects will be implanted with ACRYSOF® IQ Monofocal IOL Model SN60WF. Standard clinical practice will be followed for pre-operative testing, IOL power estimation and IOL implantation. Only one eye will be enrolled in the study per surgeon determination. The eye will undergo both an automated and manual manifest refraction assessment at 3 months postoperative.

Conditions

• Cataract

Interventions

Type	Name	Description
PROCEDURE	Manifest refraction	Manifest refraction performed by autorefraction (automated) and manual procedures (standard)
DEVICE	ACRYSOF® IQ Monofocal IOL Model SN60WF	Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
DEVICE	Topcon® KR-1W Wave-Front Analyzer	Wavefront and topography system used to obtain autorefraction data

Timeline

• Start date: 2016-09-21
• Primary completion: 2017-11-16
• Completion: 2017-11-16
• First posted: 2016-07-22
• Last updated: 2019-01-08
• Results posted: 2019-01-08