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Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verion-LenSx
Sponsored by
Gainesville Eye Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring Pseudophakic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Gainesville Eye Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Verion-LenSx

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Corneal Astigmatism
Vector change in the astigmatism measured on the cornea, in diopters
Change in Refractive Cylinder
The vector change in refractive cylinder in diopters
Spectacle Independence at Distance
Percentage of subjects that do not rely on spectacles for distance vision

Full Information

First Posted
May 3, 2016
Last Updated
October 11, 2019
Sponsor
Gainesville Eye Associates
Collaborators
Alcon, a Novartis Company
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1. Study Identification

Unique Protocol Identification Number
NCT02763124
Brief Title
Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
Official Title
Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gainesville Eye Associates
Collaborators
Alcon, a Novartis Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
Keywords
Pseudophakic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verion-LenSx
Arm Type
Experimental
Arm Description
The Verion-LenSx femtosecond laser system will be used to perform one or two corneal arcuate incisions.
Intervention Type
Procedure
Intervention Name(s)
Verion-LenSx
Intervention Description
The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
Primary Outcome Measure Information:
Title
Uncorrected Monocular Distance Visual Acuity
Description
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.
Time Frame
60 days (+/- 10 days) after laser treatment
Secondary Outcome Measure Information:
Title
Change in Corneal Astigmatism
Description
Vector change in the astigmatism measured on the cornea, in diopters
Time Frame
60 days (+/- 10 days) after laser treatment
Title
Change in Refractive Cylinder
Description
The vector change in refractive cylinder in diopters
Time Frame
60 days (+/- 10 days) after laser treatment
Title
Spectacle Independence at Distance
Description
Percentage of subjects that do not rely on spectacles for distance vision
Time Frame
60 days (+/- 10 days) after laser treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 40 or older Willing and able to provide informed consent for participation in the study. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton Blehm, MD
Organizational Affiliation
Gainesville Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gainesville Eye Associates
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

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