Personalized Remapping Training for Age-Related Macular Degeneration

Overseen By Stephen A Engel, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neovascular AMD, other visual disorders

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

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve reading for individuals with age-related macular degeneration, a condition that causes central vision loss. It tests whether moving missing text to different areas of vision can aid reading. The trial evaluates three approaches: Personalized Remapping Training, which involves practicing reading with text moved around; reading words quickly one at a time; and reading words in natural settings using virtual reality. Ideal candidates for this trial have central vision loss in both eyes, affecting activities like reading and recognizing faces, but have no history of other visual disorders. As an unphased trial, this study provides a unique opportunity to explore innovative reading strategies and potentially enhance daily life activities.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this personalized remapping training is safe for patients with central vision loss?

Earlier research has shown that perceptual learning can improve vision in people with macular degeneration, indicating that the training is generally safe and well-tolerated. No specific reports of negative effects from these exercises have emerged.

For rapid serial visual presentation (RSVP) and reading in everyday settings, studies provide less direct safety information. However, these methods involve reading and visual exercises, which are typically safe. Advancing these treatments to later study phases indicates they have been found reasonably safe.

Overall, these treatments aim to enhance reading skills and vision, usually with minimal risk. Always consult your healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Remapping Training for age-related macular degeneration because it offers a new way to help people read better despite vision loss. Unlike traditional treatments like injections or laser therapy that focus on stopping vision deterioration, this approach aims to enhance the brain's ability to process visual information differently. The technique involves innovative methods like reading words rapidly presented one at a time or within virtual reality environments, which could significantly improve reading ability and quality of life for those affected. By retraining the brain to adapt to new visual cues, this method could provide a unique and effective way to manage the challenges of macular degeneration.

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

Research has shown that personalized training can help people with age-related macular degeneration (AMD) improve their reading skills. In this trial, participants will join different treatment arms to evaluate various training methods. The Perceptual Learning arm involves practicing reading with remapping over multiple sessions. The Rapid Serial Visual Presentation arm focuses on reading words presented one at a time in rapid succession near fixation. The Reading in The Wild arm uses virtual reality to practice reading in everyday settings, such as identifying names on street signs. These training programs teach individuals with central vision loss to use other parts of their vision more effectively, leading to improved reading. Studies on techniques that adjust the speed and timing of words suggest that reading rates can increase by about 33% for those with low vision. Additionally, practicing reading in everyday settings with virtual reality may help people adapt more easily. Together, these methods show promise in helping people with AMD read more efficiently. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Central Vision Loss, specifically those who have dense blind spots in both eyes covering the central vision area and can maintain a certain level of steady gaze. It's not open to people with other visual disorders or a specific advanced form of age-related macular degeneration.

Inclusion Criteria

Bivariate contour ellipse area (BCEA) of less than 10^2 is obtained in a simple fixation task

I have large blind spots in the center of my vision in both eyes.

Exclusion Criteria

I have wet age-related macular degeneration.

I have had eye problems not related to losing my central vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Characterization and Personalization

Participants undergo initial characterization of visual field loss and perform visual tasks for personalized remapping

1 session

1 visit (in-person)

Treatment

Participants engage in reading tasks with and without remapping across three experimental arms: Perceptual Learning, Rapid Serial Visual Presentation, and Reading in The Wild

16 weeks

16 sessions (in-person)

Follow-up

Participants are monitored for reading performance and accuracy after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalised Remapping Training
• Reading text in the wild with remapping
• RSVP personalized remapping

Trial Overview The study tests if remapping text to different parts of the visual field helps reading in patients with Central Vision Loss. It involves personalized training and assessing reading performance on various tasks, comparing results with and without text remapping.

How Is the Trial Designed?

Group I: Reading in The Wild Experimental Treatment 1 Intervention

Participants will view scenes in virtual reality showing natural settings and read a single word at a time within those scenes- e.g. a name on a street sign or shop in a city scene.

Group II: Rapid Serial Visual Presentation Experimental Treatment 1 Intervention

Participants will read words presented one at a time in rapid succession near fixation.

Group III: Perceptual Learning Experimental Treatment 1 Intervention

Participants will practice reading with remapping over many sessions on different days.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4201094/

Perceptual learning in patients with macular degeneration In this study we trained patients with central vision loss in a TDT, with the target appearing on their respective PRL, and compared their results to an age- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0028393225001009

Neural and perceptual adaptations in bilateral macular ... A six-month training program in AMD patients resulted in increased grey matter volume in the cerebellum, a key region for eye movement control, ...

3. jov.arvojournals.org jov.arvojournals.org/article.aspx?articleid=2473637

The effect of normal aging and age-related macular ... However, one may expect less improvement in AMD patients if their age, which tends to be much older than those typically recruited to perceptual learning ...

4. nature.com nature.com/articles/s41746-020-00317-z

Predicting risk of late age-related macular degeneration ... Here, we demonstrate how deep learning and survival analysis can predict the probability of progression to late AMD using 3298 participants ( ...

5. ajo.com ajo.com/article/S0002-9394(25)00374-5/fulltext

Predicting Early Onset of Age-Related Macular Degeneration Multiple supervised machine learning models achieved ∼76% accuracy in predicting early-onset AMD from early comorbidities (diagnosed before age ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25368597/

Perceptual learning in patients with macular degeneration Our exploratory study suggests that training on the TDT can enhance eccentric vision in patients with central vision loss.

7. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2024.1326435/full

tRNS boosts visual perceptual learning in participants with ... Perceptual learning (PL) has shown promise in enhancing residual visual functions in patients with age-related macular degeneration (MD), ...

8. researchgate.net researchgate.net/figure/Potential-benefits-of-Perceptual-Learning-PL-in-Age-Macular-Degeneration-AMD-either_fig1_312046866

Potential benefits of Perceptual Learning (PL) in Age... Combining fixation and lateral masking training enhances perceptual learning effects in patients with macular degeneration. Article. Full-text available. Oct ...