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Not yet recruitingNCT05780931AMDUpdated Sep 29, 2026

Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration

An observational study in Age-related Macular Degeneration (AMD), sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by VA Office of Research and Development · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
50 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Age-related Macular Degeneration (AMD)

Keywords

  • Maculopathy
  • Macular dystrophy
  • Drusen
  • wet AMD
  • dry AMD
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Veterans with vision loss caused by age-related macular degeneration

Inclusion criteria

  • The subject is a Veteran
  • The subject has best-corrected visual acuity (BCVA) of 20/40 or worse in each eye, as determined by the standard Charlie Norwood VA Medical Center (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)
  • The subject has visual deficit in either eye (wavy lines and/or missing/darkened areas on the grid) determined by the standard Amsler Grid Test
  • 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 (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

Exclusion Criteria:

  • 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
  • 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.]
  • 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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralStudy-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.

    Also known as: Study-related rehabilitation procedures

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-10 weeks

  2. 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.

    Time frame: 6-10 weeks

06

Study locations

1 site
  • Charlie Norwood VA Medical Center, Augusta, GA
    Augusta, Georgia 30904-6258, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05780931
Lead sponsor
VA Office of Research and Development
Collaborators
Augusta University
Responsible party
Sponsor
First posted
Mar 23, 2023
Start date
Oct 1, 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Jay Hegde, PhD
Contact
jay.hegde@va.gov
(706) 733-0188 ext. 32508
Jay Hegde, PhD
principal investigator · Charlie Norwood VA Medical Center, Augusta, GA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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