Scotoma Perimetry Oculomotor Training

NCT05456581 | Completed

• 1 other identifier: 300006197 (R21)
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research is relevant to public health because a greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has potential to benefit millions of individuals suffering from low vision. The treatment of low vision is particularly relevant to the mission of the NEI to support research on visual disorders, mechanisms of visual function and preservation of sight. Declines in vision are particularly common in older adults and thus increasing our understanding of how to cre- ate effective means of improving vision is also highly relevant to the mission of the NIA to support research on aging and the health and well-being of older people.

Conditions

Macular Degeneration; Central Visual Impairment

Keywords

plasticity; central vision loss

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Visual Acuity after completion of Training at approximately 6 weeks and 14 weeks

  Score measured on EDTRS chart

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

• Change from Baseline Fixation stability after completion of Training at approximately 6 weeks and 14 weeks

  Dispersion of fixation locations averaged across trials for the PRL (expressed as the Bivariate contour ellipse area (BCEA) of the dispersion).

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

• Change from Baseline Saccadic re-referencing after completion of Training at approximately 6 weeks and 14 weeks

  Proportion of trials with first fixation using PRL (expressed as a % of the total number of trials).

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

Secondary Outcomes (7)

• Change from Baseline First saccade landing dispersion after completion of Training at approximately 6 weeks and 14 weeks

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

• Change from Baseline Latency of target acquisition after completion of Training at approximately 6 weeks and 14 weeks

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

• Change from Baseline Saccadic precision after completion of Training at approximately 6 weeks and 14 weeks

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

• Change from Baseline Percentage of trials that are useful after completion of Training at approximately 6 weeks and 14 weeks

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

• Change from Baseline Minimal print size from MNREAD task after completion of Training at approximately 6 weeks and 14 weeks

  Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average

Study Arms (2)

Condition 1 - 'Scotoma awareness' Training

EXPERIMENTAL

Participants will be asked to report the emotion of an emoji face ('happy' vs 'sad') that could appear anywhere on screen. For the entire duration of the training, an explicit, sharp outlined occluder surrounding the participant's true retinal scotoma will be rendered on screen. This occluder will be generated through a gaze-contingent display. The size and the contrast of the target will change adaptively in response to the patient's performance.

Behavioral: 'Scotoma awareness' Training

Condition 2 - Control Training

EXPERIMENTAL

In the control condition, participants will perform the same task as the scotoma awareness training, without the artificial visible scotoma.

Behavioral: Control Training

Interventions

'Scotoma awareness' Training BEHAVIORAL

In the 'scotoma awareness' training, patients will perform visual search and orientation discrimination tasks while an opaque occluder, custom-tailored to overlap each patient's retinal scotoma, is constantly presented on the computer screen.

Condition 1 - 'Scotoma awareness' Training

Control Training BEHAVIORAL

The task will be performed in the control group without the visible scotoma.

Condition 2 - Control Training

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severely impaired vision in both eyes (20/100 or worse)
• Diagnosis of Macular Degeneration
• Light sensitivity in the macular retina that is at least 10 dB units worse than in peripheral regions, as demonstrated by a scanning laser ophthalmoscope (SLO, MAIA)
• Medical record review indicates this disease severity level has been present for at least 2 years.

You may not qualify if:

• Inability to sit still in eye tracker for extended periods
• Inability to visualize iris on video eye tracker
• Bilateral retinal scotomas larger than 20° diameter

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of California, Riverside: collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Blindness, Cortical; Scotoma

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: November 1, 2022
• Primary Completion: June 4, 2025
• Study Completion: June 30, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Results of the project will be submitted to the relevant repository (ClinicalTrials.gov, or Open-Science Framework) within one year of the final participant completing data collection.

Locations

US (1)