Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration (AMD)

January 7, 2026 updated by: VA Office of Research and Development

Development of New Approaches to Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration

This study will help develop new methods of rehabilitating Veterans with vision loss due to Age-related macular degeneration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to develop new and improved methods of helping vision-impaired Veterans see better by using hands as "seeing eyes". This study will focus on Veterans with a common form of eye disease called age-related macular degeneration that affects older individuals.

Study Type

Observational

Enrollment (Estimated)

20

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

  • Name: Jay Hegde, PhD
  • Phone Number: 32508 (706) 733-0188
  • Email: jay.hegde@va.gov

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30904-6258
        • Charlie Norwood VA Medical Center, Augusta, GA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jay Hegde, PhD

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Veterans with vision loss caused by age-related macular degeneratioin

Description

Inclusion Criteria:

  1. The subject is a Veteran.
  2. The subject is 50 years of age.
  3. The subject has best-corrected visual acuity (BCVA) of 20/40 or worse in each eye, as determined by the standard CNVAMC optometric tests.
  4. The subject has visual field deficit of 10O in either eye as determined by the Octopus 900 perimetry (Haag-Streit Diagnostics, Haag-Streit USA, Mason, OH) administered by CNVAMC. (When the deficit/s are binocular, they do not necessarily have to be in binocularly corresponding positions.)
  5. The subject has received a formal clinical diagnosis of age-related macular degeneration (AMD) in one or both eyes (binocular AMD does not necessarily have to be in binocularly corresponding positions)7,8,56.
  6. The subject has visual deficit in either eye (wavy lines and/or missing/darkened areas on the grid) determined by the standard Amsler Grid Test7,8,56.
  7. The subject has not yet started any rehabilitative treatment for AMD-related vision loss.
  8. Both eyes of the subject are otherwise age-appropriately stable, and neither eye has any other visual defects, as determined by the standard CNVAMC ophthalmological examination.
  9. The subject must be able to understand the nature and individual consequences of the study.
  10. The subject must be able to provide signed and dated informed consent before start of any participation in the study procedures.
  11. Women with childbearing potential must test negative for pregnancy using a standard urine test prior to participating in each functional magnetic resonance imaging (fMRI) procedure. (This exclusion criterion is mandated by the Augusta University Institutional Review Board [AU IRB], which also serves as the IRB of record of the CNVAMC. It is intended as an extra precautionary measure to help ensure the health and safety of this vulnerable population. The proposed study will comply with this requirement.)

Exclusion Criteria:

  1. According to the patient's VA clinical records, the patient has one or more clinically diagnosed neurological disorder.
  2. According to the patient's VA clinical records, the patient has one or more clinically diagnosed cognitive deficits.
  3. According to the patient's VA clinical records, the patient has been clinically diagnosed with a psychiatric disorder that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study.
  4. According to the patient's VA clinical records, according to the patient, or both, the patient has motor disorder/s that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study.
  5. According to the patient's VA clinical records, according to the patient, or both, the patient has an MR-incompatible implant and/or another condition (e.g., claustrophobia) that would make it inadvisable for the subject to participate in MR imaging or any other study procedure.
  6. The patient does not understand the informed consent information and/or the standard study instructions in spoken or written English, and/or is unable to follow study instructions. [The purpose of this exclusion criterion, required by the AU IRB, is to help ensure that the subjects adequately understand all the information relevant to providing informed consent, as well as the study instructions.]
  7. Inability to give informed consent to participate in the study.
  8. Pregnancy, as determined by a standard urine test for pregnancy.
  9. Participation in other study/studies including an investigational drug or device during the present 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
This is the group of study subjects which will undergo study-related rehabilitation procedures.
Behavioral: Study-specific rehabilitation (SSR) procedures
Study-specific rehabilitation procedures will systematically manipulated the spatial or temporal synchrony (or coordination) of visual vs. haptic inputs that the subjects receive.
Other Names:
  • Study-related rehabilitation procedures
Control Group
This is the group of study subjects which will undergo control (sham) rehabilitation procedures (in addition to all their regularly scheduled treatments and interventions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of object recognition
Time Frame: 6-10 weeks
This outcome will be measured as the accuracy (% correct) with which the study subjects recognize the text objects before, during and after their participation in the study procedures.
6-10 weeks
Response of brain regions of interest (ROI) as reflected in the BOLD (blood oxygenation level-dependent) response
Time Frame: 6-10 weeks
This outcome will be measured as changes (if any) of the BOLD responses of brain ROIs before, during and after their participation in the study procedures.
6-10 weeks

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Collaborators

Augusta University

Investigators

  • Principal Investigator: Jay Hegde, PhD, Charlie Norwood VA Medical Center, Augusta, GA

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)

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4099-P
  • I21RX004099-01A1 (U.S. NIH Grant/Contract: VA Rehabilitation Research & Development Service)

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

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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