Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions

NCT ID: NCT02763124

Last Updated: 2019-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Astigmatism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Verion-LenSx

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

Group Type EXPERIMENTAL

Verion-LenSx

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Verion-LenSx

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon, a Novartis Company

INDUSTRY

Sponsor Role collaborator

Gainesville Eye Associates

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clayton Blehm, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clayton Blehm, MD

Role: PRINCIPAL_INVESTIGATOR

Gainesville Eye Associates

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gainesville Eye Associates

Gainesville, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CB-16-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cataract Refractive Suite Study
NCT02974140 TERMINATED NA