Clinical trial NCT05780931: Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
Official title: Development of New Approaches to Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Age-related Macular Degeneration (AMD)
Keywords: Maculopathy
Macular dystrophy
Drusen
wet AMD
dry AMD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Augusta University
First posted: 2023-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Veterans with vision loss caused by age-related macular degeneratioin

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of object recognition
timeFrame: 6-10 weeks
measure: Response of brain regions of interest (ROI) as reflected in the BOLD (blood oxygenation level-dependent) response
timeFrame: 6-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Charlie Norwood VA Medical Center, Augusta, GA
state: Georgia
Study officials:
affiliation: Charlie Norwood VA Medical Center, Augusta, GA
name: Jay Hegde, PhD
role: PRINCIPAL_INVESTIGATOR
References: