Scotoma Awareness Training for Low Vision

(SPOT Trial)

Overseen By Kristina Visscher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Inability to sit still, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to improve vision for individuals with severe vision impairment, particularly those with macular degeneration. The researchers aim to understand how the brain adapts after losing central vision and to discover new therapies for low vision. Participants will engage in various training methods, including Scotoma Perimetry Oculomotor Training (a type of eye movement training), to determine which method enhances their ability to recognize visual cues. Individuals with severe vision loss in both eyes due to macular degeneration for at least two years may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new therapies for vision impairment.

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 training is safe for individuals with low vision?

Research has shown that Scotoma Perimetry Oculomotor Training could benefit individuals with vision loss due to central scotomas. In one study with six participants, 83% improved their ability to focus on words for reading after the training. This suggests the treatment is generally well-received and may assist with vision-related tasks.

This treatment is neither a medication nor surgery, which usually means fewer risks of side effects. It involves visual training that enhances coordination between the brain and eyes. Being non-invasive, it typically presents few safety concerns. However, as with any new treatment, discussing potential risks with the trial team and healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help individuals with low vision become more aware of their scotomas, or blind spots. Unlike standard vision therapy that might focus on enhancing overall visual acuity, this trial uses a unique "scotoma awareness" training method where participants identify emotions on an emoji face, with a visible outline of their scotoma rendered on screen. This gaze-contingent display adapts to the participant's performance, making it a tailored approach to improving visual awareness. The hope is that by training people to recognize and adapt to their blind spots, they can experience better functional vision in daily life.

What evidence suggests that this trial's treatments could be effective for low vision?

Research has shown that Scotoma Perimetry Oculomotor Training, which participants in this trial may receive, can be a promising method for people with central vision loss. In one study with patients who had severe vision loss due to central blind spots, 83% found a new way of seeing that improved their reading ability. This was achieved by creating a new focus point on the retina, called a preferred retinal locus (PRL), which helps bypass the blind spot. Eccentric viewing training, a similar technique, is part of the control training in this trial and has also proven effective for improving low vision. These findings suggest that specific visual training can greatly enhance vision tasks for those with central vision problems. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My central vision is significantly worse than my peripheral vision.

My condition has been severe for at least 2 years.

Exclusion Criteria

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

I have large blind spots in both of my eyes.

You cannot see your own iris with a video eye tracker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo 'scotoma awareness' training with a simulated scotoma to promote PRL development

6 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in visual abilities and oculomotor strategies after training

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Control Training
• Scotoma Perimetry Oculomotor Training

Trial Overview '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.

How Is the Trial Designed?

Group I: Condition 2 - Control Training Experimental Treatment 1 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' Training Experimental Treatment 1 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.

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

In a study involving eight patients with bilateral central scotomas, using a gaze-contingent polygon overlay to delineate the scotoma significantly improved reading speed by an average of 19%.

Most participants also showed changes in their reading eye movements, suggesting that enhancing the visibility of the scotoma location can be beneficial, although further research is needed to explore the effects of longer training sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scotoma Visibility and Reading Rate with Bilateral Central Scotomas. Pratt, JD., Stevenson, SB., Bedell, HE.[2018]

Biofeedback training using Microperimetry-1 (MP-1) showed improvements in visual function for a patient with bilateral myopic macular degeneration, particularly in fixation stability and retinal sensitivity.

After training, the preferred retinal locus stability increased significantly, with the left eye showing a notable improvement in fixation from 43% to 67%, indicating that MP-1 biofeedback can be an effective intervention for enhancing visual function in patients with central scotomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microperimetry biofeedback training in a patient with bilateral myopic macular degeneration with central scotoma. Raman, R., Damkondwar, D., Neriyanuri, S., et al.[2018]

A training method for individuals with central field loss due to macular degeneration improved their speed in visual search tasks, with participants completing the task faster without losing accuracy over 480 trials.

While training increased awareness of the scotoma location for some participants, the benefits did not transfer to different visual search tasks, indicating that targeted training may help individuals better utilize their remaining vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training eye movements for visual search in individuals with macular degeneration. Janssen, CP., Verghese, P.[2019]

In a study simulating a central scotoma in normal subjects, initial exposure led to slower search times and more disorganized eye movements, highlighting the challenges faced by patients with central scotomas.

After extensive training (1782 trials), participants improved their search performance significantly, indicating that with practice, individuals can develop a preferred retinal locus (PRL) to enhance visual search efficiency despite a central scotoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation to a simulated central scotoma during visual search training. Walsh, DV., Liu, L.[2014]

A novel training method successfully induced a Preferred Retinal Locus (PRL) in eight normally sighted subjects with simulated central scotomas after just 6-10 hours of training, demonstrating the adaptability of the visual system.

The training led to significant improvements in high-level visual functions, such as letter recognition and reading, at the PRL location, suggesting potential rehabilitation benefits for individuals with central vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating oculomotor and perceptual training to induce a pseudofovea: A model system for studying central vision loss. Liu, R., Kwon, M.[2018]

In a study of six patients with severe vision loss due to central scotomas, 83% were able to establish a preferred retinal locus (PRL) for reading after just 4 to 5 hours of training, demonstrating the potential for effective visual rehabilitation.

The use of strong positive lenses and targeted training allowed patients to read at a median speed of 71 words per minute, indicating that even with significant visual impairment, reading capabilities can be improved through specialized techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Location and stability of a newly established eccentric retinal locus suitable for reading, achieved through training of patients with a dense central scotoma. Nilsson, UL., Frennesson, C., Nilsson, SE.[2022]

In a study of 106 children aged 5-8 years, it was found that most can reliably undergo automated static perimetry testing, which assesses their visual field, with proper training and familiarization procedures.

The study highlighted that age significantly affects both the endurance and reliability of responses during testing, suggesting that adjustments in testing methods may be necessary to accommodate younger children's attention and fatigue levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated visual field examination in children aged 5-8 years. Part I: Experimental validation of a testing procedure. Tschopp, C., Safran, AB., Viviani, P., et al.[2022]

Training individuals with central visual field loss to use a pseudo-preferred retinal locus (pPRL) significantly improves their gaze stability and accuracy, with these improvements being retained over a week and transferable to a new location.

The study suggests that low vision rehabilitation can effectively utilize pPRL training to enhance oculomotor control, indicating that early intervention may help patients adapt better as their vision deteriorates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral oculomotor training in individuals with healthy visual systems: Effects of training and training transfer. Rose, D., Bex, P.[2020]

A new training procedure using scanning laser ophthalmoscopy (SLO) was developed to help patients with central field loss improve their reading by utilizing multiple preferred retinal loci (PRLs), showing feasibility in a pilot trial with five subjects.

The training led to significant improvements in visual acuity and reading strategies, with subjects successfully adopting new PRLs, indicating potential for enhanced reading performance despite their visual impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique to train new oculomotor behavior in patients with central macular scotomas during reading related tasks using scanning laser ophthalmoscopy: immediate functional benefits and gains retention. Déruaz, A., Goldschmidt, M., Whatham, AR., et al.[2018]

In a study of 20 patients with age-related macular degeneration, training to use a new retinal locus for reading significantly improved reading speed from an average of 9.0 words per minute to 68.3 words per minute after just 5.2 hours of training.

The training involved using a scanning laser ophthalmoscope for monitoring and instruction, demonstrating that with proper techniques, patients can effectively adapt their reading strategies despite having a central visual scotoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with AMD and a large absolute central scotoma can be trained successfully to use eccentric viewing, as demonstrated in a scanning laser ophthalmoscope. Nilsson, UL., Frennesson, C., Nilsson, SE.[2022]

In a study of 35 patients with central scotoma, visual rehabilitation using microperimeter biofeedback significantly improved fixation stability and reading performance after just 10 training sessions.

Patients also reported enhanced quality of life, as indicated by increased scores on the National Eye Institute Visual Function Questionnaire, demonstrating the overall efficacy of this rehabilitation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Low Vision Rehabilitation Using Microperimetric Acoustic Biofeedback Training in Patients with Central Scotoma. Sahli, E., Altinbay, D., Bingol Kiziltunc, P., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3223708/

A Study of Eccentric Viewing Training for Low Vision ... EV training can be used as an effective method for low vision rehabilitation in patients with central scotomas. Keywords: Eccentric viewing, Low vision ...

2. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(23)00154-9/fulltext

Eccentric Viewing Training for Age-Related Macular Disease All participants received standard low-vision rehabilitation. Main Outcome Measures. The primary outcome was patient-reported visual task ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05456581?tab=table

NCT05456581 | Scotoma Perimetry Oculomotor Training This will provide a unique data set to help those developing interventions for central vision loss understand how approaches to visual rehabilitation, and ...

4. trialx.com trialx.com/clinical-trials/listings/227763/scotoma-perimetry-oculomotor-training/

Scotoma Perimetry Oculomotor Training This will provide a unique data set to help those developing interventions for central vision loss understand how approaches to visual ...

5. withpower.com withpower.com/trial/phase-macular-degeneration-8-2022-d1116

Scotoma Awareness Training for Low Vision (SPOT Trial) In a study of six patients with severe vision loss due to central scotomas, 83% were able to establish a preferred retinal locus (PRL) for reading after just 4 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642005006044

Preferred Retinal Locus Development in Patients with ... All of the patients in this study developed a repeatable preferred retinal locus within 6 months of visual loss in their second affected eye. Reading ...

7. researchgate.net researchgate.net/publication/311953306_Training_eye_movements_for_visual_search_in_individuals_with_macular_degeneration

Training eye movements for visual search in individuals ... We report a method to train individuals with central field loss due to macular degeneration to improve the efficiency of visual search.