Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

Astigmatism Clinical Trial

Official title:

Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763124
• Other study ID #: CB-16-001
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2019
• Source: Gainesville Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age 40 or older

• Willing and able to provide informed consent for participation in the study.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Astigmatism

Intervention

Procedure:
• Verion-LenSx
The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions

Locations

Country	Name	City	State
United States	Gainesville Eye Associates	Gainesville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Gainesville Eye Associates	Alcon, a Novartis Company

Country where clinical trial is conducted

United States, 

Outcome

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