What side effects are associated with this type of intervention?

Common treatments for central vision loss, such as those involving neural plasticity and oculomotor training, generally focus on improving visual function through non-invasive methods. Side effects are minimal but may include temporary eye strain or discomfort during training sessions. Other treatments, like low-vision devices, can improve reading and overall visual ability but may not significantly impact mobility or visual motor skills. These interventions are generally safe with no significant adverse effects reported.

What prior FDA approvals exist?

Currently, there are no FDA-approved therapies specifically based on neural plasticity for the treatment of central vision loss. However, treatments such as anti-VEGF injections (e.g., aflibercept, bevacizumab) are commonly used for conditions like age-related macular degeneration, which can cause central vision loss. These treatments focus on reducing abnormal blood vessel growth and leakage in the retina. Research into neural plasticity and stem cell transplantation is ongoing, with promising early results, but these approaches have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives for treating low vision in central vision loss patients include transcranial direct current stimulation (tDCS) and oculomotor training. These therapies aim to enhance neural plasticity and improve visual function. tDCS has shown potential in treating inattention in other conditions, suggesting it may benefit visual processing. Oculomotor training focuses on improving eye movement control and visual field utilization, which can help patients adapt to vision loss.

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Scotoma Awareness Training for Low Vision (SPOT 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

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.

Must not have

Inability to sit still in eye tracker for extended periods

Bilateral retinal scotomas larger than 20° diameter

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new training method for older adults with Macular Degeneration, a condition causing central vision loss. The training uses a simulated blind spot to help patients become aware of their vision loss and develop new ways to see better. By making patients aware of their blind spot, the training aims to improve their vision and daily functioning. Eccentric viewing training has been shown to improve near visual acuity, reading speed, and daily functioning in people with central vision loss.

Who is the study for?

This trial is for adults with severe vision impairment (20/100 or worse) due to Macular Degeneration. Participants must have had this level of vision loss for at least two years and show specific light sensitivity differences between their macula and peripheral retina. Those who can't remain still during eye tracking or have very large retinal blind spots are excluded.

What is being tested?

'Scotoma awareness' Training, which aims to improve understanding and adaptation to blind spots in central vision, is being tested against a control training program. The study seeks to enhance low vision therapies based on how the brain adapts after central vision loss.

What are the potential side effects?

Since this trial involves non-invasive training programs rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

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

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My central vision is significantly worse than my peripheral vision.

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My condition has been severe for at least 2 years.

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I have been diagnosed with Macular Degeneration.

Exclusion Criteria

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

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I can't stay still for long periods during eye tracking tests.

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I have large blind spots in both of my eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 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 6 weeks and 14 weeks

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

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

Secondary study objectives

Change from Baseline Contrast Sensitivity after completion of Training at approximately 6 weeks and 14 weeks

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

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

+4 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: Condition 2 - Control TrainingExperimental Treatment1 Intervention

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

Group II: Condition 1 - 'Scotoma awareness' TrainingExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control Training

2013

N/A

~240

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for central vision loss often focus on enhancing neural plasticity to improve visual function. These treatments may include visual training exercises, which aim to stimulate the brain's ability to adapt and reorganize itself to compensate for lost vision. Additionally, pharmacological interventions, such as the use of antioxidants or neuroprotective agents, can help protect remaining retinal cells and support neural health. Understanding and leveraging neural plasticity is crucial for central vision loss patients because it offers a pathway to potentially restore some visual function and improve quality of life, even when direct restoration of lost vision is not possible.