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OpenTrials
Completed

NCT Number: NCT02763124

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.

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Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Verion-LenSx

Procedure

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

Primary outcomes

  1. Uncorrected Monocular Distance Visual Acuity

    Time frame: 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 outcomes

  1. Change in Corneal Astigmatism

    Time frame: 60 days (+/- 10 days) after laser treatment

    Vector change in the astigmatism measured on the cornea, in diopters

  2. Change in Refractive Cylinder

    Time frame: 60 days (+/- 10 days) after laser treatment

    The vector change in refractive cylinder in diopters

  3. Spectacle Independence at Distance

    Time frame: 60 days (+/- 10 days) after laser treatment

    Percentage of subjects that do not rely on spectacles for distance vision

Sponsors and collaborators

Lead sponsor

Gainesville Eye Associates

Other

Collaborators

  • Alcon, a Novartis Company

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 5, 2016
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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