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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.
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

SPOT Trial Summary

This trial will test if a new method of electrical stimulation can help people with low vision see better. The treatment is relevant to public health because it has the potential to improve the lives of millions of people suffering from low vision.

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.Check my eligibility
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.See study design
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.

SPOT Trial 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.

SPOT Trial 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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

SPOT 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

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,466 Total Patients Enrolled
University of California, RiversideOTHER
24 Previous Clinical Trials
12,240 Total Patients Enrolled

Media Library

Scotoma Perimetry Oculomotor Training Clinical Trial Eligibility Overview. Trial Name: NCT05456581 — N/A
Central Vision Loss Research Study Groups: Condition 1 - 'Scotoma awareness' Training, Condition 2 - Control Training
Central Vision Loss Clinical Trial 2023: Scotoma Perimetry Oculomotor Training Highlights & Side Effects. Trial Name: NCT05456581 — N/A
Scotoma Perimetry Oculomotor Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456581 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort currently participating in this clinical trial?

"Affirmative. Clinicaltrials.gov illustrates that the clinical trial began on November 1st and has recently been updated, with an aim to recruit 16 individuals from one site."

Answered by AI

Who is able to be a participant in this clinical trial?

"This research is targeting 16 individuals with macular degeneration aged between 18 and 89. To qualify, applicants must have severely diminished sight in both eyes (20/100 or worse), be officially diagnosed with Macular Degeneration, demonstrably heightened light sensitivity in the macula compared to other regions of their retina as measured by a scanning laser ophthalmoscope (SLO MAIA), and medical documentation verifying that these symptoms have persisted for at least two years."

Answered by AI

Are opportunities for patients to participate in this trial still available?

"Affirmative. According to the data available on clinicaltrials.gov, this medical trial has been actively searching for participants since November 1st 2022 and is currently in need of 16 individuals at a single research centre."

Answered by AI

What are the primary goals of this research endeavor?

"This trial seeks to evaluate the efficacy of this treatment via assessment of Fixation Stability, Latency of Target Acquisition, Saccadic Precision, and Percentage of Trials that are Useful from Baseline to 6 weeks post-training completion and 14 weeks post-training completion. Secondary outcomes include examining changes in Latency of Target Acquisition (time until target is visible outside scotoma), Saccadic Precision (dispersion when placing targets outside scotoma) and Percentage of Trials that are useful (% dots relative to total trials)."

Answered by AI

Does this research accept individuals aged 75 or above?

"To join the clinical trial, individuals must be aged 18 to 89. Additionally, there are 30 trials for minors and 187 specially designed for people over 65 years of age."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
UAB
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Scotoma Perimetry Oculomotor Training
Kristina M Visscher 2022. "Scotoma Perimetry Oculomotor Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05456581.
All > Age Related Macular Degeneration > Stargardt Disease
~5 spots leftby Jan 2025
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