Central Visual ImpairmentFLAPNCT05454124
Factors in Learning And Plasticity: Macular Degeneration
A study testing Training visual sensitivity and Combination training in people with Central Visual Impairment and Macular Degeneration, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has the 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
- Central Visual Impairment, Macular Degeneration
- What is being tested?
- Training visual sensitivity and Combination training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18-89
- Severely impaired vision in both eyes (20/100 or worse)
- diagnosis of Macular Degeneration by an Ophthalmologist
- 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 (MAIA)
- Medical record review indicating this level of disease severity has been present for at least 2 years
- Reside within 50 miles of study site
Who cannot join
- Pacemaker or any ferromagnetic metal implanted in their body
- Metal of any type implanted in their head (limited dental work is acceptable)
- Claustrophobia
- Being hearing-impaired
- Weight over 300 pounds
- Maximum body girth over 60 inches
Show all 11Show fewer
- Previous serious head injury
- Presence of hallucinations or delusions
- Excessive old, or colorful tattoos, especially near the head
- Pregnancy
- Braces/permanent retainer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB
Birmingham, Alabama, 35294
Rachel A Chua, MS, 205-410-4041, r2chel@uab.edu
Kristina M Visscher, PhD, 205-934-0497, kmv@uab.edu
About this study
Official title: Characterization of Multiple Factors in Training and Plasticity in Central Vision Loss: Macular Degeneration
A greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has the 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. The comparison of different training and outcome factors is in line with the NIMH RDOC framework and studies in an aging population are consistent with the mission of the NIA.
Read the detailed description
Research on perceptual learning (PL) has been dominated by studies that seek to isolate and improve individual visual processes. However, an important translational outcome of PL research is to address the needs of patients with vision loss, who seek to improve performance on daily tasks such as reading, navigation, and face recognition. These more ecological cases of behavioral change and cortical plasticity, which are inherently complex and integrative, have revealed significant gaps in a more holistic understanding of how multiple visual processes and their associated brain systems jointly contribute to durable and generalizable PL. To address these gaps, here the investigators study simulated and natural central vision loss. The investigators focus on macular degeneration (MD), one of the most common causes of vision loss (projected to affect 248 million people worldwide by 2040), which results from damage to photoreceptors in the macula that disrupts central vision. Such central vision loss is a superb lens through which study to how ecologically relevant changes in the use of vision relate to changing brain activity and connectivity because it represents a massive alteration in visual experience requiring reliance on peripheral vision for daily tasks. With the use of eye-trackers and gaze-contingent displays that induce central scotomas, central vision loss can be simulated in normally seeing individuals, who then develop peripheral looking patterns that resemble compensatory vision strategies seen in MD patients. Ideal use of peripheral vision requires improvement in multiple vision domains, three of the most important being: early visual processing (e.g., visual sensitivity), mid-level visual processing (e.g., spatial integration), and attention and eye-movements. To date, no study has systematically investigated these three domains of PL and their neural underpinnings. The proposed research plan rests on rigorous prior work showing that PL influences multiple brain structures and functions related to these three domains. The investigators propose a novel approach of systematically measuring how different training regimes related to the three domains influence a broad range of psychophysical and ecological behaviors (Aim 1), how these changes arise from plasticity in brain structure and function (Aim 2), and how PL after simulated central vision loss compares to PL in MD (Aim 3). This work is significant and innovative as it will be the first integrated study of PL characterizing multiple trainable factors and their impact on diverse behavioral outcomes and on cutting-edge assessments of neural representations and dynamics. It is also the first study to directly compare PL in MD patients with PL in a controlled model system of central visual field loss with simulated scotomas, which if validated will allow the use of this model system to interrogate MD in larger samples of healthy individuals. The investigators will also share a unique dataset that will help the field to understand behavioral and neural plasticity after central vision loss and individual differences in responsiveness to training. Finally, this work will illuminate basic mechanisms of brain plasticity after sensory loss that may generalize to other forms of rehabilitation after peripheral or central damage.
- Conditions
- Central Visual Impairment, Macular Degeneration
- Being tested
- Training visual sensitivity, Combination training
- Keywords
- plasticity, central vision loss, perceptual learning
- Medical subject headings
- Blindness, Cortical, Macular Degeneration, Scotoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training visual sensitivityBehavioural
Investigators adopt a standard PL approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold contrast. Across training blocks, Gabors will range in spatial frequency, where contrast is adapted with a 3/1 staircase. Whenever a specific contrast threshold is reached, spatial frequency will increase by 2 cycles per degree and contrast will be reset. Preliminary data from this method in normally seeing and MD participants show both feasibility and tentative evidence that this training gives rise to improvements in acuity.
Combination trainingBehavioural
Daily tasks involve a combination of being sensitive to basic visual features, being able to integrate these features, and directing attention and eye movements to better evaluate the information of potential interest. To address this integrative nature of real-world vision, this condition combines elements of training visual sensitivity, spatial integration, and spatial attention.
| Study group | Role | What they receive |
|---|---|---|
| Training visual sensitivity | Experimental | A standard Perceptual Learning approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold- level contrast. Preliminary data, using this method, in normally seeing and MD participants show both feasibility and preliminary evidence that this training gives rise to improvements in acuity. Receives: Behavioral: Training visual sensitivity |
| Combination training | Experimental | In combination training, investigators test the extent to which a combined training gives rise to the joint benefits of each training individually, or integrative benefits potentially surpassing benefits of the individual training alone. The visual sensitivity task will alternate across blocks with the spatial integration task, using the timing of targets and location switches from spatial attention training. Receives: Behavioral: Combination training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Radial Bias from the Crowding Task after completion of Training at approximately 7 weeks
The ratio of the crowding threshold along the axis connected to the fovea vs. along the orthogonal axis.
Measured: Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average
Change from Baseline Saccadic Precision after Completion of Training at approximately 7 weeks
Consistency across trials in placement of the first saccade calculated by the distribution across trials (bivariate contour ellipse area) of the landing point of the first fixation of each trial.
Measured: Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average
Change from Baseline Fixation Stability after Completion of Training at approximately 7 weeks
Normalizing fixations in the PRL to the first fixation to that region and calculating the distribution of all fixation locations in this normalized space (measured as a bivariate contour ellipse area).
Measured: Baseline and Within 3 weeks of training completion, training is complete 7 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 posted12 Jul 2022
- Study start1 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Visual ImpairmentStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside
- Responsible party
- Principal investigator, Kristina M Visscher, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454124
- Sponsor's protocol ID
- 300006197 (Study 2)
- Acronym
- FLAP
- Status last verified
- Feb 2026
- First submitted
- 5 Jul 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- 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-ScienceFramework, MRI data to OpenfMRI) within one year of the final participant completing data collection. The investigators expect to report participant flow by group (intervention or control), participant demographics (age, sex assigned at birth, years of education), outcome measures and statistical analyses, adverse events (if applicable), and limitations or caveats of our results. The investigators also will ensure that the final protocol and statistical analysis code are uploaded to the record. No Protected Health Information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Multiple Factors in Training and Plasticity in Central Vision Loss: Macular Degeneration
- ClinicalTrials.gov ID
- NCT05454124
- Acronym / sponsor ID
- FLAP / 300006197 (Study 2)
- Conditions
- Central Visual Impairment, Macular Degeneration
- Keywords
- plasticity, central vision loss, perceptual learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of California, Riverside
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has the 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. The comparison of different training and outcome factors is in line with the NIMH RDOC framework and studies in an aging population are consistent with the mission of the NIA.
Detailed description
Research on perceptual learning (PL) has been dominated by studies that seek to isolate and improve individual visual processes. However, an important translational outcome of PL research is to address the needs of patients with vision loss, who seek to improve performance on daily tasks such as reading, navigation, and face recognition. These more ecological cases of behavioral change and cortical plasticity, which are inherently complex and integrative, have revealed significant gaps in a more holistic understanding of how multiple visual processes and their associated brain systems jointly contribute to durable and generalizable PL. To address these gaps, here the investigators study simulated and natural central vision loss. The investigators focus on macular degeneration (MD), one of the most common causes of vision loss (projected to affect 248 million people worldwide by 2040), which results from damage to photoreceptors in the macula that disrupts central vision. Such central vision loss is a superb lens through which study to how ecologically relevant changes in the use of vision relate to changing brain activity and connectivity because it represents a massive alteration in visual experience requiring reliance on peripheral vision for daily tasks. With the use of eye-trackers and gaze-contingent displays that induce central scotomas, central vision loss can be simulated in normally seeing individuals, who then develop peripheral looking patterns that resemble compensatory vision strategies seen in MD patients. Ideal use of peripheral vision requires improvement in multiple vision domains, three of the most important being: early visual processing (e.g., visual sensitivity), mid-level visual processing (e.g., spatial integration), and attention and eye-movements. To date, no study has systematically investigated these three domains of PL and their neural underpinnings. The proposed research plan rests on rigorous prior work showing that PL influences multiple brain structures and functions related to these three domains. The investigators propose a novel approach of systematically measuring how different training regimes related to the three domains influence a broad range of psychophysical and ecological behaviors (Aim 1), how these changes arise from plasticity in brain structure and function (Aim 2), and how PL after simulated central vision loss compares to PL in MD (Aim 3). This work is significant and innovative as it will be the first integrated study of PL characterizing multiple trainable factors and their impact on diverse behavioral outcomes and on cutting-edge assessments of neural representations and dynamics. It is also the first study to directly compare PL in MD patients with PL in a controlled model system of central visual field loss with simulated scotomas, which if validated will allow the use of this model system to interrogate MD in larger samples of healthy individuals. The investigators will also share a unique dataset that will help the field to understand behavioral and neural plasticity after central vision loss and individual differences in responsiveness to training. Finally, this work will illuminate basic mechanisms of brain plasticity after sensory loss that may generalize to other forms of rehabilitation after peripheral or central damage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training visual sensitivity | Experimental | Behavioral: Training visual sensitivityA standard Perceptual Learning approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold- level contrast. Preliminary data, using this method, in normally seeing and MD participants show both feasibility and preliminary evidence that this training gives rise to improvements in acuity. |
| Combination training | Experimental | Behavioral: Combination trainingIn combination training, investigators test the extent to which a combined training gives rise to the joint benefits of each training individually, or integrative benefits potentially surpassing benefits of the individual training alone. The visual sensitivity task will alternate across blocks with the spatial integration task, using the timing of targets and location switches from spatial attention training. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-89
- Severely impaired vision in both eyes (20/100 or worse)
- diagnosis of Macular Degeneration by an Ophthalmologist
- 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 (MAIA)
- Medical record review indicating this level of disease severity has been present for at least 2 years
Key exclusion criteria (11 listed)
- Pacemaker or any ferromagnetic metal implanted in their body
- Metal of any type implanted in their head (limited dental work is acceptable)
- Claustrophobia
- Being hearing-impaired
- Weight over 300 pounds
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 |
|---|---|---|
| Training visual sensitivityInvestigators adopt a standard PL approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold contrast. Across training blocks, Gabors will range in spatial frequency, where contrast is adapted with a 3/1 staircase. Whenever a specific contrast threshold is reached, spatial frequency will increase by 2 cycles per degree and contrast will be reset. Preliminary data from this method in normally seeing and MD participants show both feasibility and tentative evidence that this training gives rise to improvements in acuity. | Behavioural | Training visual sensitivity |
| Combination trainingDaily tasks involve a combination of being sensitive to basic visual features, being able to integrate these features, and directing attention and eye movements to better evaluate the information of potential interest. To address this integrative nature of real-world vision, this condition combines elements of training visual sensitivity, spatial integration, and spatial attention. | Behavioural | Combination training |
Primary outcome
Change from Baseline Radial Bias from the Crowding Task after completion of Training at approximately 7 weeks
Time frame: Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average
The ratio of the crowding threshold along the axis connected to the fovea vs. along the orthogonal axis.
Change from Baseline Saccadic Precision after Completion of Training at approximately 7 weeks
Time frame: Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average
Consistency across trials in placement of the first saccade calculated by the distribution across trials (bivariate contour ellipse area) of the landing point of the first fixation of each trial.
Change from Baseline Fixation Stability after Completion of Training at approximately 7 weeks
Time frame: Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average
Normalizing fixations in the PRL to the first fixation to that region and calculating the distribution of all fixation locations in this normalized space (measured as a bivariate contour ellipse area).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Results of the project will be submitted to the relevant repository (ClinicalTrials.gov, or Open-ScienceFramework, MRI data to OpenfMRI) within one year of the final participant completing data collection. The investigators expect to report participant flow by group (intervention or control), participant demographics (age, sex assigned at birth, years of education), outcome measures and statistical analyses, adverse events (if applicable), and limitations or caveats of our results. The investigators also will ensure that the final protocol and statistical analysis code are uploaded to the record. No Protected Health Information will be shared.
Related trials for Central Visual Impairment
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
Diabetic Macular Edema (DME)
Not yet recruiting
Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss
Macular Degeneration, Central Visual Impairment
Not yet recruiting
joyVision: The Superiority of Co-design in the Development of a Serious Game for Children With Cerebral Visual Impairment
Cerebral Visual Impairment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training visual sensitivity and Combination training in people with Central Visual Impairment and Macular Degeneration, 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel A Chua, MS (205-410-4041, r2chel@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Radial Bias from the Crowding Task after completion of Training at approximately 7 weeks (time frame: Baseline and Within 3 weeks of training completion, training is complete 7 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 9 Feb 2026.