Macular DegenerationSPOTNCT05456581
Scotoma Perimetry Oculomotor Training
A study testing 'Scotoma awareness' Training in people with Macular Degeneration and Central Visual Impairment, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The proposed research is relevant to public health because a greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has potential to benefit millions of individuals suffering from low vision. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Macular Degeneration, Central Visual Impairment
- What is being tested?
- 'Scotoma awareness' Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severely impaired vision in both eyes (20/100 or worse)
- Diagnosis of Macular Degeneration
- Light sensitivity in the macular retina that is at least 10 dB units worse than in peripheral regions, as demonstrated by a scanning laser ophthalmoscope (SLO, MAIA)
- Medical record review indicates this disease severity level has been present for at least 2 years.
Who cannot join
- Inability to sit still in eye tracker for extended periods
- Inability to visualize iris on video eye tracker
- Bilateral retinal scotomas larger than 20° diameter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Methods to Quantify and Train Eye Movement Strategies in Macular Degeneration
The proposed research is relevant to public health because a greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has 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.
Declines in vision are particularly common in older adults and thus increasing our understanding of how to cre- ate effective means of improving vision is also highly relevant to the mission of the NIA to support research on aging and the health and well-being of older people.
Read the detailed description
This proposal tests a novel 'scotoma awareness' approach to aid those with Macular Degeneration (MD). MD is the leading cause of central vision loss worldwide. MD patients spontaneously develop oculomotor strategies to overcome loss of central vision, such as developing a new peripheral fixation spot to replace the fovea (preferred retinal locus, or PRL). However, development of a PRL and the rate of success in developing one vary greatly, meaning some patients live years without making effective use of their spared vision. Recent, studies in Vision Science show that training healthy participants with gaze-contingent displays, obstructing central vision ('simulated scotoma'), leads to development of PRLs at a faster time scale than found for MD patients. Additionally, oculomotor metrics developed in our lab, are effective in characterizing individual eye movement patterns in simulated scotoma participants. The ability to describe differences in compensatory strategies in MD represents a crucial step towards individualized rehabilitative strategies, which could be further improved by accelerating PRL development. However, it is unclear whether these results can be reproduced in those with MD. It has been suggested that the visible, sharp-edged occluder in the gaze- contingent displays increases scotoma awareness, thus accelerating PRL development. Many MD patients are unaware of the location of their scotoma, with some persisting to use their damaged fovea as a fixation spot. No study to date has translated the use of a simulated scotoma to promote rapid PRL development in MD patients. As a first step towards addressing individual differences in patients and examine whether Vision Science paradigms can be used as a rehabilitative tool in MD, we propose two Aims: In Aim 1 we will use a set of oculomotor metrics to characterize individual profiles of compensation. In Aim 2 we will test the effectiveness of the visible, simulated scotoma as a technique to promote the rapid development of a PRL. Patients will undergo a 'scotoma awareness' training, in which a simulated scotoma, individually tailored for each patient, will be used to help them visualize their region of vision loss. Patients will be tested on the same metrics from Aim 1 and a battery of visual and cognitive assessments before and after the 'scotoma awareness' (or control) sessions. This will enable quantification of the effect of scotoma awareness both in terms of visual abilities and oculomotor strategies, and test the hypothesis that awareness of the location and extent of retinal damage promotes fast PRL development. While challenging, the use of eye tracking techniques in patients could be highly rewarding if this scotoma awareness procedure proves to be effective. A null result would be equally informative, suggesting fundamental differences between physiological and simulated scotomas, thus providing a limit in the use of simulations of retinal damage as a framework for the study of retinal pathologies such as MD. This will provide a unique data set to help those developing interventions for central vision loss understand how approaches to visual rehabilitation, and individual differences, give rise to training outcomes.
- Conditions
- Macular Degeneration, Central Visual Impairment
- Being tested
- 'Scotoma awareness' Training, Control Training
- Keywords
- plasticity, central vision loss
- Medical subject headings
- Macular Degeneration, Blindness, Cortical, Scotoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Scotoma awareness' TrainingBehavioural
In the 'scotoma awareness' training, patients will perform visual search and orientation discrimination tasks while an opaque occluder, custom-tailored to overlap each patient's retinal scotoma, is constantly presented on the computer screen.
Control TrainingBehavioural
The task will be performed in the control group without the visible scotoma.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 - 'Scotoma awareness' Training | Experimental | 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. Receives: Behavioral: 'Scotoma awareness' Training |
| Condition 2 - Control Training | Experimental | In the control condition, participants will perform the same task as the scotoma awareness training, without the artificial visible scotoma. Receives: Behavioral: Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Fixation Stability After Completion of Training at Approximately 6 Weeks and 14 Weeks
Dispersion of fixation locations averaged across trials in which the participant used their PRL (expressed as the Bivariate contour ellipse area (BCEA) of the dispersion of fixation locations).
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Visual Acuity After Completion of Training at Approximately 6 Weeks and 14 Weeks
Score of Change in baseline visual acuity, in logMAR units after training. Measured as post-test minus pre-test.
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Saccadic Re-referencing After Completion of Training at Approximately 6 Weeks and 14 Weeks
Proportion of trials with first fixation using PRL (expressed as a % of the total number of trials). Expressed as post-test minus pre-test.
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Secondary outcomes (7)
Change From Baseline First Saccade Landing Dispersion After Completion of Training at Approximately 6 Weeks and 14 Weeks
The dispersion of the end point of the first saccade (expressed as the Bivariate contour ellipse area, BCEA of the dispersion). BCEA is the area (in deg^2) of an ellipse encompassing the fixation points, as described by Crossland et al., 2011.
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Latency of Target Acquisition After Completion of Training at Approximately 6 Weeks and 14 Weeks
The mean time until target is visible outside scotoma (expressed in seconds).
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Saccadic Precision After Completion of Training at Approximately 6 Weeks and 14 Weeks
The dispersion of the end point of the saccade that puts the target outside scotoma (expressed as the BCEA of the dispersion).
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Percentage of Trials That Are Useful After Completion of Training at Approximately 6 Weeks and 14 Weeks
How often participants place the target outside of the scotoma (% of dots in Saccadic precision relative to total trials). Definition of "trials that are useful" is that the target is placed outside the scotoma at some point during the trial.
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Minimal Print Size From MNREAD Task After Completion of Training at Approximately 6 Weeks and 14 Weeks
For the MNREAD test we will primarily rely upon minimal print size (a secondary measure of acuity). MNREAD is a computerized version of the task from Mansfield et al., 1993 from Gordon Legge's lab. Participants perform the task without any simulated scotoma. Sentences are shown to participants in a standardized order, from largest to smallest. The words are read out loud. The task stops when the participant can no longer read the sentence. The number of sentences is thus a measure of how small the print can be for a participant to read it effectively. Larger number of sentences is a better minimal print size. Thus we expect that effective training will result in greater values at post-test than at baseline.
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Time-to-complete Trailmaking B Subtest After Completion of Training at Approximately 6 Weeks and 14 Weeks
We will look at time-to-complete the Trail Making B subtest, measured in seconds. Post-test minus baseline. Trailmaking B test is often thought of as a measure of executive function. The task requires ordering numbers and letters, and switching between them (e.g., Find 1, then A, then 2, then B, then 3... etc.).
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Contrast Sensitivity After Completion of Training at Approximately 6 Weeks and 14 Weeks
Measured via Robson-Pelli charts. Contrast sensitivity is a measure of what visual contrast the participant can detect. This outcome is in units of log contrast sensitivity
Measured: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Nov 2022
- Primary completion4 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Kristina M Visscher, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456581
- Sponsor's protocol ID
- IRB-300006197 (R21)
- Other IDs
- R21EY033623
- Acronym
- SPOT
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2022
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of the project will be submitted to the relevant repository (ClinicalTrials.gov, or Open-Science Framework) within one year of the final participant completing data collection. We expect to report participant flow by group (intervention or control), participant demographics and other baseline characteristics, outcome measures and statistical analyses, adverse events (if applicable), and limitations or caveats of our results. We also will ensure that the final protocol and statistical analysis plan are uploaded to the record.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Methods to Quantify and Train Eye Movement Strategies in Macular Degeneration
- ClinicalTrials.gov ID
- NCT05456581
- Acronym / sponsor ID
- SPOT / IRB-300006197 (R21)
- Conditions
- Macular Degeneration, Central Visual Impairment
- Keywords
- plasticity, central vision loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of California, Riverside, National Eye Institute (NEI)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research is relevant to public health because a greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has 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.
Declines in vision are particularly common in older adults and thus increasing our understanding of how to cre- ate effective means of improving vision is also highly relevant to the mission of the NIA to support research on aging and the health and well-being of older people.
Detailed description
This proposal tests a novel 'scotoma awareness' approach to aid those with Macular Degeneration (MD). MD is the leading cause of central vision loss worldwide. MD patients spontaneously develop oculomotor strategies to overcome loss of central vision, such as developing a new peripheral fixation spot to replace the fovea (preferred retinal locus, or PRL). However, development of a PRL and the rate of success in developing one vary greatly, meaning some patients live years without making effective use of their spared vision. Recent, studies in Vision Science show that training healthy participants with gaze-contingent displays, obstructing central vision ('simulated scotoma'), leads to development of PRLs at a faster time scale than found for MD patients. Additionally, oculomotor metrics developed in our lab, are effective in characterizing individual eye movement patterns in simulated scotoma participants. The ability to describe differences in compensatory strategies in MD represents a crucial step towards individualized rehabilitative strategies, which could be further improved by accelerating PRL development. However, it is unclear whether these results can be reproduced in those with MD. It has been suggested that the visible, sharp-edged occluder in the gaze- contingent displays increases scotoma awareness, thus accelerating PRL development. Many MD patients are unaware of the location of their scotoma, with some persisting to use their damaged fovea as a fixation spot. No study to date has translated the use of a simulated scotoma to promote rapid PRL development in MD patients. As a first step towards addressing individual differences in patients and examine whether Vision Science paradigms can be used as a rehabilitative tool in MD, we propose two Aims: In Aim 1 we will use a set of oculomotor metrics to characterize individual profiles of compensation. In Aim 2 we will test the effectiveness of the visible, simulated scotoma as a technique to promote the rapid development of a PRL. Patients will undergo a 'scotoma awareness' training, in which a simulated scotoma, individually tailored for each patient, will be used to help them visualize their region of vision loss. Patients will be tested on the same metrics from Aim 1 and a battery of visual and cognitive assessments before and after the 'scotoma awareness' (or control) sessions. This will enable quantification of the effect of scotoma awareness both in terms of visual abilities and oculomotor strategies, and test the hypothesis that awareness of the location and extent of retinal damage promotes fast PRL development. While challenging, the use of eye tracking techniques in patients could be highly rewarding if this scotoma awareness procedure proves to be effective. A null result would be equally informative, suggesting fundamental differences between physiological and simulated scotomas, thus providing a limit in the use of simulations of retinal damage as a framework for the study of retinal pathologies such as MD. This will provide a unique data set to help those developing interventions for central vision loss understand how approaches to visual rehabilitation, and individual differences, give rise to training outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condition 1 - 'Scotoma awareness' Training | Experimental | Behavioral: 'Scotoma awareness' TrainingParticipants 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. |
| Condition 2 - Control Training | Experimental | Behavioral: Control TrainingIn the control condition, participants will perform the same task as the scotoma awareness training, without the artificial visible scotoma. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severely impaired vision in both eyes (20/100 or worse)
- Diagnosis of Macular Degeneration
- Light sensitivity in the macular retina that is at least 10 dB units worse than in peripheral regions, as demonstrated by a scanning laser ophthalmoscope (SLO, MAIA)
- Medical record review indicates this disease severity level has been present for at least 2 years.
Key exclusion criteria (3 listed)
- Inability to sit still in eye tracker for extended periods
- Inability to visualize iris on video eye tracker
- Bilateral retinal scotomas larger than 20° diameter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Scotoma awareness' TrainingIn the 'scotoma awareness' training, patients will perform visual search and orientation discrimination tasks while an opaque occluder, custom-tailored to overlap each patient's retinal scotoma, is constantly presented on the computer screen. | Behavioural | Condition 1 - 'Scotoma awareness' Training |
| Control TrainingThe task will be performed in the control group without the visible scotoma. | Behavioural | Condition 2 - Control Training |
Primary outcome
Change From Baseline Fixation Stability After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Dispersion of fixation locations averaged across trials in which the participant used their PRL (expressed as the Bivariate contour ellipse area (BCEA) of the dispersion of fixation locations).
Change From Baseline Visual Acuity After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Score of Change in baseline visual acuity, in logMAR units after training. Measured as post-test minus pre-test.
Change From Baseline Saccadic Re-referencing After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Proportion of trials with first fixation using PRL (expressed as a % of the total number of trials). Expressed as post-test minus pre-test.
7 secondary outcomes
Change From Baseline First Saccade Landing Dispersion After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Latency of Target Acquisition After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Saccadic Precision After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Percentage of Trials That Are Useful After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Minimal Print Size From MNREAD Task After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Time-to-complete Trailmaking B Subtest After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Change From Baseline Contrast Sensitivity After Completion of Training at Approximately 6 Weeks and 14 Weeks
Time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Results of the project will be submitted to the relevant repository (ClinicalTrials.gov, or Open-Science Framework) within one year of the final participant completing data collection. We expect to report participant flow by group (intervention or control), participant demographics and other baseline characteristics, outcome measures and statistical analyses, adverse events (if applicable), and limitations or caveats of our results. We also will ensure that the final protocol and statistical analysis plan are uploaded to the record.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Scotoma awareness' Training in people with Macular Degeneration and Central Visual Impairment, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Fixation Stability After Completion of Training at Approximately 6 Weeks and 14 Weeks (time frame: Baseline, after training completion, training is complete 6 weeks from baseline on average, and at follow up, 14 weeks from baseline on average). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.