Vision Improvement for Patients With Age-Related Macular Degeneration

August 30, 2024 updated by: VIS, Inc.
This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Yes

Description

Inclusion Criteria:

Subjects who meet all of the following criteria are candidates for this study:

  1. Male or Female
  2. Any race
  3. Patient is at least 50 years old.
  4. Patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination.
  5. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
  6. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
  7. Patient has moderate to severe vision impairment due to age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal less than or equal to 0.25; logMAR ≥ 0.60).in the better eye.
  8. Patient has CDVA of 20/400 or better (decimal greater than or equal to 0.05; logMAR ≤ 1.30) in the worse eye.
  9. Patient is not a contact lens (CL) wearer.
  10. Patient is willing and able to comply with all examinations.
  11. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

Subjects who meet any of the following criteria are to be excluded from this study:

  1. Corneal disease or corneal disorder in either eye.
  2. Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola.
  3. Gonzalez-Markowitz chart Potential Visual Acuity (PVA) in the eye to be treated that is not improved by at least four lines compared to CDVA;
  4. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma;
  5. Previous corneal surgery in the eye to be treated; and
  6. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vision Improvement
Procedure: Vision Improvement
Laser Vision Improvement for Patients with Age-Related Macular Degeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 1 year
Standard measurements of visual acuity before and after treatment
1 year

Collaborators and Investigators

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

Sponsor

VIS, Inc.

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIS #001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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