Vision Training for Age-Related Macular Degeneration

(FLAP Trial)

Overseen By Kristina M Visscher, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pacemaker, Claustrophobia, Hallucinations, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist individuals with age-related macular degeneration, a condition that causes vision loss. It examines whether eye training can improve vision by testing two methods: one focuses on visual sensitivity (Training visual sensitivity), and the other combines various visual tasks (Combination training). Individuals diagnosed with macular degeneration, who have severely impaired vision in both eyes and have experienced these issues for at least two years, might be suitable candidates. The research aims to discover treatments that could benefit millions facing vision loss. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that may lead to new treatments for vision loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this vision training is safe for individuals with age-related macular degeneration?

Research has shown that training the eyes to see better can aid individuals with age-related macular degeneration (AMD). Some studies have found that vision can improve through exercises that enhance the ability to notice details more clearly. This training is generally safe, as it relies on exercises rather than drugs or surgery.

For training that combines various exercises, specific safety information remains less clear. However, since it involves exercises and not medication, it is likely low-risk. These methods are non-invasive, meaning they don't involve surgery or drugs, which typically results in fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vision Training for Age-Related Macular Degeneration because it offers a unique approach compared to traditional treatments like anti-VEGF injections. Unlike these standard therapies that mainly focus on slowing disease progression by targeting blood vessel growth, this trial explores perceptual learning techniques to enhance visual processing. The "Training visual sensitivity" arm specifically aims to improve how the brain processes visual information, potentially enhancing visual acuity through exercises with Gabor patches. Meanwhile, the "Combination training" arm combines visual sensitivity training with spatial integration tasks, potentially offering synergistic benefits that surpass the effects of either method alone. This innovative focus on retraining the brain's visual processing is what makes these treatments stand out.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research has shown that training to enhance visual acuity can benefit individuals with age-related macular degeneration (AMD). Studies have found that this training can clarify and sharpen vision, assisting with everyday tasks and making daily activities easier for those with low vision. In this trial, participants will join different treatment arms. One arm will focus on training visual sensitivity, which has shown promise in improving acuity. Another arm will explore combination training, where researchers are investigating whether combining different training methods proves more effective than using just one. Although the effectiveness of this combination is still under study, early results suggest it might improve overall vision. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Reside within 50 miles of study site

You have very poor vision in both eyes (20/100 or worse).

Exclusion Criteria

You weigh more than 300 pounds.

You have had a severe head injury in the past.

You have too many, or very colorful tattoos, especially near your head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo perceptual learning training focusing on visual sensitivity, spatial integration, and attention and eye-movements.

7 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in visual processing and brain plasticity after training completion.

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Combination training
• Training visual sensitivity

Trial Overview 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.

How Is the Trial Designed?

Group I: Training visual sensitivity Experimental Treatment 1 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 training Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

Published Research Related to This Trial

A survey of 136 optometrists revealed that 68% are private practitioners, and most provide low vision rehabilitation training for 1 hour or less, indicating a potential gap in comprehensive training for patients with moderate visual impairment.

The study highlights the need for standardized terminology and management criteria in low vision rehabilitation, suggesting that more clinical research and education are necessary to improve the effectiveness and accessibility of care for patients with vision impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of optometric low vision rehabilitation training methods for the moderately visually impaired. Kammer, R., Sell, C., Jamara, RJ., et al.[2015]

A training program focused on oculomotor control significantly increased reading speed by an average of 24.7 words per minute in 16 patients with age-related macular degeneration (AMD) over an 8-week period.

The training emphasized eye movement exercises rather than direct reading practice, suggesting that improving eye movement control can enhance reading abilities in AMD patients, regardless of their visual acuity or age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye-movement training for reading in patients with age-related macular degeneration. Seiple, W., Szlyk, JP., McMahon, T., et al.[2006]

In a study of patients with advanced age-related macular degeneration (AMD), visual rehabilitation using an acoustic biofeedback training system significantly improved various visual functions, including visual acuity and contrast sensitivity.

The training involved ten sessions of 10 minutes each, conducted twice a week, and resulted in enhanced quality of life for patients by helping them shift fixation from damaged areas of the retina to healthier regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of biofeedback rehabilitation based on visual evoked potentials analysis in patients with advanced age-related macular degeneration. Verdina, T., Piaggi, S., Ferraro, V., et al.[2021]

Patients with dry age-related macular degeneration (AMD) who received additional reading training (RT) after adapting to magnifying aids showed significant improvements in reading speed and emotional status, indicating enhanced vision rehabilitation.

The study involved 37 participants over 6 weeks, and results demonstrated that RT not only improved reading performance but also contributed to better quality of life and reduced depression, highlighting its potential as a valuable intervention for AMD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home reading training on reading and quality of life in AMD-a randomized and controlled study. Kaltenegger, K., Kuester, S., Altpeter-Ott, E., et al.[2020]

In a study of 91 older adults with macular disease undergoing low vision rehabilitation, baseline cognitive status did not significantly predict most functional outcomes, suggesting that cognitive impairment alone should not exclude patients from rehabilitation programs.

However, those with marginal cognitive impairment showed worse functional trajectories in specific areas, such as meal preparation and activities requiring distance vision, indicating a need for tailored support in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbid cognitive impairment and functional trajectories in low vision rehabilitation for macular disease. Whitson, HE., Ansah, D., Sanders, LL., et al.[2021]

In a study of 91 older adults (average age 80.1) undergoing low-vision rehabilitation for macular disease, nearly 30% had memory deficits, which significantly impacted their ability to perform near-vision tasks during rehabilitation.

Participants with memory deficits showed a decline in functional abilities, while those with better memory reported improvements, suggesting that a simple memory test could help identify individuals needing additional support in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory deficit associated with worse functional trajectories in older adults in low-vision rehabilitation for macular disease. Whitson, HE., Whitaker, D., Sanders, LL., et al.[2021]

Low-vision rehabilitation significantly improved overall visual ability in participants with macular diseases, with treatment effects peaking at 4 months and remaining robust over a year, compared to a control group that showed a decline in visual ability.

Both treatment and control groups demonstrated improvements in visual ability from baseline to 1 year, but the treatment group had a greater enhancement in overall visual ability, indicating the effectiveness of low-vision rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of low-vision rehabilitation in 2 cohorts derived from the veterans affairs Low-Vision Intervention Trial. Stelmack, JA., Tang, XC., Wei, Y., et al.[2022]

Age-related macular degeneration (ARMD) is becoming more common in the aging U.S. population, leading to significant vision loss that can affect independence and quality of life.

Low vision rehabilitation techniques, focusing on magnification, contrast, and illumination, are essential for improving visual function and helping individuals regain independence despite ARMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision rehabilitation of persons with age related macular degeneration. Siemsen, DW., Brown, WL.[2019]

In a study of 188 patients with age-related macular degeneration, combining behavioral activation with low vision rehabilitation led to greater improvements in functional vision compared to supportive therapy alone, particularly in reading and daily tasks.

Patients receiving the combined treatment showed the most significant benefits when their visual acuity was better than 20/70, suggesting that this approach is especially effective for those with mild visual impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Deemer, AD., Massof, RW., Rovner, BW., et al.[2018]

A survey of VA blind rehabilitation centers revealed that while 82% of optometrists prescribe eccentric viewing (EV) training, there is no consensus on the criteria for selecting the best area for training, indicating a lack of standardized practice.

The duration of EV training varies widely among patients, ranging from 20 minutes to nearly 24 hours, highlighting inconsistencies in training methods and the need for further research to evaluate the efficacy and cost-effectiveness of EV training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a standard of care for eccentric viewing training? Stelmack, JA., Massof, RW., Stelmack, TR.[2019]

In a study of 36 patients with juvenile macular dystrophy, both training methods (rapid serial visual presentation and sensomotoric training) significantly improved reading speed after 4 weeks, with increases of 21 words per minute for RSVP and 20 words per minute for SM.

The RSVP method was associated with shorter fixation durations, while the SM method led to fewer forward saccades, suggesting that each training method influences reading strategies differently, which could help tailor future interventions for patients with central vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training to improve reading speed in patients with juvenile macular dystrophy: a randomized study comparing two training methods. Nguyen, NX., Stockum, A., Hahn, GA., et al.[2019]

Patients with macular degeneration often struggle with reading, and while traditional methods like magnification and scotoma awareness training are common, newer approaches such as eccentric training and oculomotor training have shown to be effective in improving reading skills.

Ophthalmologists are encouraged to adopt a comprehensive approach to reading rehabilitation that includes cognitive skill assessment, optimal eyewear, tailored reading materials, and targeted training for better eye movement control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of reading skills in patients with age-related macular degeneration. Markowitz, M., Daibert-Nido, M., Markowitz, SN.[2019]

Citations

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Eccentric Viewing Training for Age-Related Macular Disease On average, visual acuity deteriorated by 0.20 logMAR (SD: 0.47) over the study, from a mean value of 0.67 logMAR (SD: 0.24) to 0.87 logMAR (SD: 0.41). There ...

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Rethinking Clinical Trials in Age-Related Macular Degeneration This review highlights the transformative potential of AI in optimizing clinical trial outcomes for patients with nAMD or GA secondary to AMD.

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Combined automated screening for age-related macular ... The AMD and DR screening tools achieved excellent performance operating together to identify two retinal diseases prospectively in mixed datasets, demonstrating ...

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Age-related macular degeneration: Epidemiology, genetics ... Age-related macular degeneration (AMD) is a complex eye disorder and is the leading cause of incurable blindness worldwide in the elderly.

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A Study to Evaluate the Safety and Efficacy of RQC for AMD To evaluate the safety and efficacy of resveratrol, quercetin, and curcumin in combination (RQC) over 2 years in patients with age-related macular degeneration ...