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

Trial Summary

What is the purpose of this trial?

A greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has the potential to benefit millions of individuals suffering from low vision. The treatment of low vision is particularly relevant to the mission of the NEI to support research on visual disorders, mechanisms of visual function, and preservation of sight. The comparison of different training and outcome factors is in line with the NIMH RDOC framework and studies in an aging population are consistent with the mission of the NIA.

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 data supports the effectiveness of the treatment for Vision Training for Age-Related Macular Degeneration?

Research shows that low vision rehabilitation, which includes training with magnifying aids, can improve reading speed, emotional well-being, and quality of life for people with age-related macular degeneration. ^{1 2 3 4 5}

Is vision training for age-related macular degeneration safe?

The studies reviewed do not specifically address the safety of vision training for age-related macular degeneration, but they do not report any safety concerns or adverse effects related to the training methods used. ^{2 6 7 8 9}

How does the Vision Training treatment for Age-Related Macular Degeneration differ from other treatments?

The Vision Training treatment for Age-Related Macular Degeneration is unique because it focuses on improving visual skills through exercises like eye-movement training and biofeedback, rather than relying solely on magnification aids or medications. This approach aims to enhance reading speed, visual acuity, and quality of life by training the brain to use healthier parts of the retina more effectively. ^{2 8 10 11 12}

Eligibility Criteria

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

I am between 18 and 89 years old.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Memory deficit associated with worse functional trajectories in older adults in low-vision rehabilitation for macular disease. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of home reading training on reading and quality of life in AMD-a randomized and controlled study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Vision rehabilitation of persons with age related macular degeneration. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of low-vision rehabilitation in 2 cohorts derived from the veterans affairs Low-Vision Intervention Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Survey of optometric low vision rehabilitation training methods for the moderately visually impaired. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Comorbid cognitive impairment and functional trajectories in low vision rehabilitation for macular disease. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of biofeedback rehabilitation based on visual evoked potentials analysis in patients with advanced age-related macular degeneration. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Is there a standard of care for eccentric viewing training? [2019]

10. England pubmed.ncbi.nlm.nih.gov

Training to improve reading speed in patients with juvenile macular dystrophy: a randomized study comparing two training methods. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Rehabilitation of reading skills in patients with age-related macular degeneration. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Eye-movement training for reading in patients with age-related macular degeneration. [2006]