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Vision Training for Age-Related Macular Degeneration (FLAP Trial)

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medical record review indicating this level of disease severity has been present for at least 2 years

Aged 18-89

Must not have

Presence of hallucinations or delusions

Maximum body girth over 60 inches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to better understand how the brain adapts to vision loss in order to develop new therapies to improve quality of life for those with low vision.

Who is the study for?

This trial is for adults aged 18-89 with severe vision impairment (20/100 or worse) due to Macular Degeneration, confirmed by an ophthalmologist. Participants must have had this condition for at least two years and live within 50 miles of the study site. Those with certain body measurements, metal implants, claustrophobia, hearing impairments, significant head injuries, mental health conditions like hallucinations/delusions, or specific tattoos near the head cannot join.

What is being tested?

The study explores how different training methods can improve visual sensitivity in people suffering from low vision caused by Macular Degeneration. It aims to understand how the brain adapts and learns despite central vision loss which could lead to new treatments that help preserve sight.

What are the potential side effects?

Since this trial involves non-invasive training exercises rather than drugs or surgery, side effects are minimal but may include eye strain or fatigue from visual tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medical records show my condition has been severe for at least 2 years.

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I am between 18 and 89 years old.

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I have been diagnosed with Macular Degeneration by an eye doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience hallucinations or delusions.

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My body's widest part is over 60 inches.

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I am hearing-impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and within 3 weeks of training completion, training is complete 7 weeks from baseline on average for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Fixation Stability after Completion of Training at approximately 7 weeks

Change from Baseline Radial Bias from the Crowding Task after completion of Training at approximately 7 weeks

Change from Baseline Saccadic Precision after Completion of Training at approximately 7 weeks

Other study objectives

Change from Baseline Acuity after Completion of Training at approximately 7 weeks

Change from Baseline Completion time in the trail making task after Completion of Training at approximately 7 weeks

Change from Baseline Contrast Sensitivity after Completion of Training at approximately 7 weeks

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Training visual sensitivityExperimental Treatment1 Intervention

A standard Perceptual Learning approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold- level contrast. Preliminary data, using this method, in normally seeing and MD participants show both feasibility and preliminary evidence that this training gives rise to improvements in acuity.

Group II: Combination trainingExperimental Treatment1 Intervention

In combination training, investigators test the extent to which a combined training gives rise to the joint benefits of each training individually, or integrative benefits potentially surpassing benefits of the individual training alone. The visual sensitivity task will alternate across blocks with the spatial integration task, using the timing of targets and location switches from spatial attention training.

0 / 6Eligibility criteria met