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Clinical Trials/NCT06121219
NCT06121219
Recruiting
Not Applicable

Effect of Visual Retraining on Visual Loss Following Cortical Damage

University of Rochester1 site in 1 country100 target enrollmentSeptember 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vision Loss Partial
Sponsor
University of Rochester
Enrollment
100
Locations
1
Primary Endpoint
Change in Mean Direction Discrimination Threshold
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

Registry
clinicaltrials.gov
Start Date
September 5, 2024
End Date
January 1, 2032
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Krystel Huxlin

James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Mean Direction Discrimination Threshold

Time Frame: Baseline to 8-12 months

For each subject, the investigators will measure the change in ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle with respect to the stimulus. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance on our 2AFC task, with task difficulty adjusted on a 3:1 staircase. The degrees of visual angle for the stimulus vary from 90 degrees (fully vertical) to 0.1 degrees (virtually overlapping the horizontal axis). These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training

Change in Mean Direction Integration Threshold

Time Frame: Baseline to 8-12 months

This will measure the change in ability of subjects to integrate across a range of motion directions measured in degrees of visual angle, with respect to the stimulus. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance on our 2AFC task, with task difficulty adjusted on a 3:1 staircase. The degrees of visual angle for the stimulus vary from 90 degrees (fully vertical) to 0.1 degrees (virtually overlapping the horizontal axis) . These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

Change in Mean Contrast Sensitivity for Direction

Time Frame: Baseline to 8-12 months

Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. The investigators will measure the luminance contrast, measured in percentage of contrast with respect to the stimulus, that can be reliably detected at a 72-75% correct level of performance. Contrast will vary between 100% (maximum contrast of black on grey) and 0.1% (minimum contrast visible of grey-on-grey) based on subject performance and a 3:1 staircase. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

Change in Mean Contrast Sensitivity for Static Orientation

Time Frame: Baseline to 8-12 months

Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. The investigators will measure the luminance contrast, measured in percentage of contrast with respect to the stimulus, that can be reliably detected at a 72-75% correct level of performance. Contrast will vary between 100% (maximum contrast of black on grey) and 0.1% (minimum contrast visible of grey-on-grey) based on subject performance and a 3:1 staircase. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-6 months, then baseline to 8-12 months from start of training.

Secondary Outcomes

  • Humphrey 10-2 and 24-2 perimetry(Baseline to 8-12 months)
  • Goldmann perimetry(Baseline to 8-12 months)
  • MAIA Visual Field Perimetry(Baseline to 8-12 months)

Study Sites (1)

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