An interventional study of 'Scotoma awareness' Training and Control Training in Macular Degeneration and Central Visual Impairment, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Basic science
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.
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.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 21 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
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.
Behavioral: 'Scotoma awareness' Training
In the control condition, participants will perform the same task as the scotoma awareness training, without the artificial visible scotoma.
Behavioral: Control Training
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.
The task will be performed in the control group without the visible scotoma.
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).
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 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.
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 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.
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 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.
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
The mean time until target is visible outside scotoma (expressed in seconds).
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
The dispersion of the end point of the saccade that puts the target outside scotoma (expressed as the BCEA of the dispersion).
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
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.
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
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.
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
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.).
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
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
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
We recruited people with macular degeneration who met our strict inclusion and exclusion criteria. These included participants aged 18-89 with 20/100 or worse vision, an MD dx, at least 2 years of history of MD, capability to see well enough to perform a microperimetry evaluation using a MAIA. Exclusion criteria: hearing impaired, previous serious head injury, neurological disorder, hallucinations/delusions.
| Milestone | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Started | 8 | 6 |
| Completed | 7 | 5 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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).
| Bivariate contour ellipse area (deg^2) | Simulated Scotoma | No Simulated Scotoma |
|---|---|---|
| Posttest - Baseline | 2.737921593 ± 5.799342792 | 3.510922586 ± 15.55387014 |
| follow up - Baseline | 15.5 ± 8.49 | — |
Score of Change in baseline visual acuity, in logMAR units after training. Measured as post-test minus pre-test.
| Acuity change (difference of logMAR) | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | -0.101956375 ± 0.082936861 | 0.029403725 ± 0.096555141 |
| follow up - Baseline | -0.060662638 ± 0.090003409 | 0 ± 0.141421356 |
Proportion of trials with first fixation using PRL (expressed as a % of the total number of trials). Expressed as post-test minus pre-test.
| Percent | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | -10.36 ± 31.2 | -4.5 ± 23.46 |
| follow up - Baseline | 3.28 ± 54 | — |
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.
| degree^2 | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | -7.8 ± 40.2 | -23.6 ± 22.9 |
| follow up - Baseline | -7.9 ± 103 | — |
The mean time until target is visible outside scotoma (expressed in seconds).
| seconds | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | .30 ± .79 | .71 ± 1.13 |
| follow up - Baseline | -.0588 ± 0.69 | — |
The dispersion of the end point of the saccade that puts the target outside scotoma (expressed as the BCEA of the dispersion).
| degree^2 | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | 16.8 ± 60.0 | -8.56 ± 47.91 |
| follow up - Baseline | 60.52 ± 65 | — |
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.
| Percent | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | -2.5 ± 23 | -18.75 ± 39.0 |
| follow up - Baseline | -25.58 ± 27.69 | — |
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.
| number of sentences read correctly | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | 0 ± 0.577 | 0.6 ± 1.14 |
| follow up - Baseline | -.2 ± 1.48 | 1.33 ± .577 |
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.).
| seconds | Simulated Scotoma | No Simulated Scotoma. |
|---|---|---|
| Posttest - Baseline | -19.7 ± 208.12 | -66.4 ± 74.57 |
| follow up - Baseline | -23.6 ± 301.34 | -99.06 ± 12.77 |
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
| log contrast sensitivity. | Condition 1 - 'Scotoma Awareness' Training | Condition 2 - Control Training |
|---|---|---|
| Posttest - Baseline | .003 ± .17 | -.017 ± .14 |
| follow up - Baseline | 0.0388 ± 0.1526 | -0.0133 ± 0.18 |
Collected over from enrollment until end of follow-up, up to 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Condition 1 - 'Scotoma Awareness' Training | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Condition 2 - Control Training | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
7 Participants dropped from the study prior to completing baseline measures; this is why the number of baseline participants (14) is smaller than the number in Participant Flow (21).
| Age, Categorical(Participants) | Simulated Scotoma | No Simulated Scotoma | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 |
| >=65 years | 7 | 6 | 13 |
| Sex: Female, Male(Participants) | Simulated Scotoma | No Simulated Scotoma | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 6 | 5 | 11 |
| Race (NIH/OMB)(Participants) | Simulated Scotoma | No Simulated Scotoma | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 7 | 6 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Simulated Scotoma | No Simulated Scotoma | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 6 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: 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.
Ran from Nov 2022 to primary completion in Jun 2025, 31 months.
Results were first posted in Sep 2026, 1 year 3 months after primary completion.
Of 104 non-industry interventional studies with no phase under Macular Degeneration, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 31 months is below that.
Counting every sponsor, half of 132 studies reached it within 37 months; a quarter within 17 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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