Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Procedure: Verion-LenSx

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Gainesville Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verion-LenSx; The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.	Procedure: Verion-LenSx; The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Monocular Distance Visual Acuity	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.	60 days (+/- 10 days) after laser treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gainesville Eye Associates
• Collaborators: Alcon, a Novartis Company

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pseudophakic
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CB-16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO