Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Procedure: Verion-LenSx

• Registration Number: NCT02763124
• Lead Sponsor: Gainesville Eye Associates

Brief Summary

To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.

Detailed Description

The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2019-02-20
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Results First Posted: 2019-11-01
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 40 or older
• Willing and able to provide informed consent for participation in the study.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Verion-LenSx	Verion-LenSx	The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.

Primary Outcome Measures

Name	Time	Method
Uncorrected Monocular Distance Visual Acuity	60 days (+/- 10 days) after laser treatment	Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Change in Corneal Astigmatism	60 days (+/- 10 days) after laser treatment	Vector change in the astigmatism measured on the cornea, in diopters
Change in Refractive Cylinder	60 days (+/- 10 days) after laser treatment	The vector change in refractive cylinder in diopters
Spectacle Independence at Distance	60 days (+/- 10 days) after laser treatment	Percentage of subjects that do not rely on spectacles for distance vision

Trial Locations

Locations (1)

Gainesville Eye Associates; 🇺🇸 Gainesville, Georgia, United States