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

16 Participants Needed

Trial Summary

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 Scotoma Awareness Training for Low Vision?

Research shows that training can help people with central vision loss use other parts of their eyes more effectively for tasks like reading and visual search. Studies found that with training, individuals improved their ability to focus on words and objects, and these skills were retained over time, suggesting that similar training could be beneficial for those with low vision. ^{1 2 3 4 5}

Is Scotoma Awareness Training safe for humans?

The research does not provide specific safety data for Scotoma Awareness Training, but it suggests that similar training methods have been used without reported safety issues in patients with central scotomas and children undergoing visual field assessments. ^{2 6 7 8 9}

How is Scotoma Perimetry Oculomotor Training different from other treatments for low vision?

Scotoma Perimetry Oculomotor Training is unique because it focuses on training the eyes to use a different part of the retina for vision, called a preferred retinal locus (PRL), to improve reading and visual tasks despite central vision loss. This approach is different from other treatments as it involves oculomotor training (eye movement training) to establish a new, more effective retinal location for vision, rather than relying on medication or surgery. ^{1 2 3 10 11}

What is the purpose of this trial?

This trial tests a new training method for older adults with Macular Degeneration, a condition causing central vision loss. The training uses a simulated blind spot to help patients become aware of their vision loss and develop new ways to see better. By making patients aware of their blind spot, the training aims to improve their vision and daily functioning. Eccentric viewing training has been shown to improve near visual acuity, reading speed, and daily functioning in people with central vision loss.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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]

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]

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 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 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]

References

1. England 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. [2018]

2. United States 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. [2022]

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

Peripheral oculomotor training in individuals with healthy visual systems: Effects of training and training transfer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Adaptation to a simulated central scotoma during visual search training. [2014]

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

Training eye movements for visual search in individuals with macular degeneration. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Low Vision Rehabilitation Using Microperimetric Acoustic Biofeedback Training in Patients with Central Scotoma. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Automated visual field examination in children aged 5-8 years. Part I: Experimental validation of a testing procedure. [2022]

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

Scotoma Visibility and Reading Rate with Bilateral Central Scotomas. [2018]

9. India pubmed.ncbi.nlm.nih.gov

Microperimetry biofeedback training in a patient with bilateral myopic macular degeneration with central scotoma. [2018]

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

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

11. England 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. [2022]