Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration

NCT05780931 | Not Yet Recruiting

• 2 other identifiers: C4099-PI21RX004099-01A1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Age-related Macular Degeneration (AMD)

Keywords

Maculopathy; Macular dystrophy; Drusen; wet AMD; dry AMD

Outcome Measures

Primary Outcomes (2)

• Accuracy of object recognition

  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

  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

Study Arms (2)

Treatment Group

This is the group of study subjects which will undergo study-related rehabilitation procedures.

Behavioral: Study-specific rehabilitation (SSR) 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).

Interventions

Study-specific rehabilitation (SSR) procedures BEHAVIORAL

Study-specific rehabilitation procedures will systematically manipulated the spatial or temporal synchrony (or coordination) of visual vs. haptic inputs that the subjects receive.

Also known as: Study-related rehabilitation procedures

Treatment Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Veterans with vision loss caused by age-related macular degeneratioin

You may qualify if:

• The subject is a Veteran.
• The subject is 50 years of age.
• The subject has best-corrected visual acuity (BCVA) of 20/40 or worse in each eye, as determined by the standard CNVAMC optometric tests.
• 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.)
• 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.
• 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.
• The subject has not yet started any rehabilitative treatment for AMD-related vision loss.
• 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.
• The subject must be able to understand the nature and individual consequences of the study.
• The subject must be able to provide signed and dated informed consent before start of any participation in the study procedures.

You may not qualify if:

• According to the patient's VA clinical records, the patient has one or more clinically diagnosed neurological disorder.
• According to the patient's VA clinical records, the patient has one or more clinically diagnosed cognitive deficits.
• 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.
• 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.
• 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.
• Inability to give informed consent to participate in the study.
• Pregnancy, as determined by a standard urine test for pregnancy.
• Participation in other study/studies including an investigational drug or device during the present study.

Sponsors & Collaborators

• Augusta University: collaborator
• VA Office of Research and Development: lead

Study Sites (1)

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, 30904-6258, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jay Hegde, PhD

  Charlie Norwood VA Medical Center, Augusta, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Hegde, PhD

CONTACT

(706) 733-0188; jay.hegde@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)