VIS Opti-K Vision Improvement for Presbyopes (VIS Opti-K 002)

November 19, 2024 updated by: VIS, Inc.
The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The VIS Opti-K device was used to irradiate the cornea with light that changed corneal shape.

Study Type

Observational

Enrollment (Actual)

135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients had documented presbyopia and a need for near vision improvement

Description

Inclusion Criteria:

Female or male Any race 40 years of age or older Presbyopia

Exclusion Criteria:

None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected distance and near visual acuities
Time Frame: Up to 24 months post-treatment
Uncorrected distance and near visual acuities are measured using ETDRS or similar charts.
Up to 24 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIS, Inc.

Investigators

  • Principal Investigator: Michael J Berry, PhD, VIS, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2007

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIS Opti-K-Presbyopia #002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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