Age-related Macular DegenerationNCT03848663
Visual Remapping to Aid Reading With Field Loss
A study testing Traditional Remapping and Personalized Remapping in people with Age-related Macular Degeneration, run by University of Minnesota at 1 site in United States.
Trial summary
Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Traditional Remapping and Personalized Remapping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 16 years or older
- Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
- Stable fixation (+/- 1 deg) using their PRL.
- No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
- Satisfactory calibration achievable using eye tracker
Who cannot join
- Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
- Poor fixation (worse than+/- 1 deg) using their PRL.
- Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
- Satisfactory calibration not achievable using eye tracker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gordon Legge, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Stephen Engel
About this study
Official title: Remapping the Visual Field to Aid Reading With Central Scotomas
Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field.
Read the detailed description
Following initial characterization of their visual field loss, the participant's performance in reading tasks will be measured with and without remapping. Tasks will include reading groups of random letters, words, simple sentences, and "natural" text from the environment (taken from phone apps, signage, etc). Different kinds of remappings will be used by participants, including traditional and personalized remapping. For control observers, differently shaped artificial scotomas will be used.
Participants interested in the study will be brought in for an initial visit. All participants will be administered the MMSE. Observers who pass the criteria for the study will then have the remainder of the procedures described to them verbally prior to undergoing the remainder of the consent process (see below). Participants will then undergo a standard exam at the UMN eye clinic, if they have not had one within the last month.
Participants will then have their scotomas mapped using a microperimeter housed in the psychology department to give size and shape information. Additional perimetry may also be conducted using either of the two displays (either HMD or desk mounted computer monitor) we have developed. Here, patients will be asked to fixate at a spot on screen and identify visual stimuli presented at different regions of the screen. The size and locations of visual stimuli patients were unable to identify will provide the size and location of the scotoma. Another additional manual perimetry protocol may be conducted as well. This would involve asking subjects to fixate at the center of a tangent screen, and asking them to identify dots temporarily presented on the screen by the researcher using a laser pointer. The locations of dots that patients are unable to identify will provide the size and location of the scotoma. The location and extent of each eye's scotoma and PRL will be used as software inputs on either device. Perimetry using one or all of the methods above will be performed until acceptable information about the scotoma extent and location is obtained.
In a second visit, participants will perform the visual tasks that are used as the basis of their personalized remapping, letter perimetry. Participants will first view and report three randomly selected horizontally arranged letters placed at different locations in the visual field. This letter perimetry task will take about 40 min and will cover a large part of the visual field.
Participants will then read single words whose letters have been displaced from horizontal in various ways that comprise candidate remappings generated on the basis of the letter perimetry results. This personalization test will take about 40 minutes, and will find a good remapping strategy for the individual. Subjects will then be introduced to the reading tasks that comprise the remainder of the study
In 6 additional sessions, participants will perform various reading tasks using different remappings. In all of these, text will be displayed on the screen, and the task is simply to read aloud what was presented. Two sessions will involve reading single words, one session will involve reading strings of 3 letters that are not arranged horizontally, two sessions will involve reading short sentences, and one session will involve reading naturalistic text (from phone apps, signage, menus, etc). In all sessions, some reading will be with remapping, some will be without. Both traditional and personalized remapping will be used.
In all these sessions, the eye tracker will be calibrated to participants' individual head and eye position. This will involve fixating at different points on the device screen (HMD or desk-mounted) as the eye is imaged by the eye trackers. This may take up to 45 minutes in the initial session, if various combinations of head and eye positions are required for the eye trackers to work well. But once completed, calibration is much faster in subsequent sessions. Quick perimetry validation may also be conducted in each session.
Throughout all testing, patients will be asked if they feel any discomfort, and will be able to take a break or quit testing at any point.
Including the initial visit, testing for any given patient is anticipated to last no more than eight sessions over eight weeks. Enrolling participants, testing, and data analysis for all participants is anticipated to take five years from the date of enrollment of the first participant.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Traditional Remapping, Personalized Remapping
- Keywords
- Scotoma, Remapping, Reading, Low vision, Visual aid
- Medical subject headings
- Macular Degeneration, Scotoma, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional RemappingBehavioural
Shifting text outside of scotoma
Personalized RemappingBehavioural
Shifting text based on individual letter-based perimetry
| Study group | Role | What they receive |
|---|---|---|
| Patients with scotoma | Experimental | No remapping (control condition), traditional remapping, personalized remapping Receives: Behavioral: Traditional Remapping; Behavioral: Personalized Remapping |
| Normally sighted with artificial scotoma | Active comparator | No remapping (control condition), traditional remapping, personalized remapping Receives: Behavioral: Traditional Remapping; Behavioral: Personalized Remapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading Speed for Individual Words
How quickly participants can correctly read displayed text
Measured: Measured during third visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Reading Speed for Sentences
How quickly participants can correctly read displayed text
Measured: Measured during fourth visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Reading Speed for Natural Text Samples
How quickly participants can correctly read displayed text
Measured: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Reading error rate for Individual Words
How many mistakes participants make
Measured: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Reading error rate for Sentences
How many mistakes participants make
Measured: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Reading error rate for Natural Text Samples
How many mistakes participants make
Measured: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Secondary outcomes (5)
Eye fixation quality for words
Variance of x and y eye position coordinates computed during fixation periods while reading
Measured: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye fixation quality for sentences
Variance of x and y eye position coordinates computed during fixation periods while reading
Measured: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye movement quality for sentences
Number off leftward (regressive) eye movements during sentence reading
Measured: Measured during fourth visit
Eye fixation quality for natural text samples
Variance of x and y eye position coordinates computed during fixation periods while reading
Measured: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye movement quality for natural text samples
Number off leftward (regressive) eye movements during natural text reading
Measured: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Feb 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Engel, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848663
- Sponsor's protocol ID
- REMAP002
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2019
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Perimetry, psychophysical and eye-tracking data will be deidentified upon acquisition, and indexed using only a subject code. These data will be stored on a secure server for sharing upon request by a PI of a research team. We will offer psychophysical and eye tracking data along with appropriate metadata specifying details of the test (remapping used, stimulus protocol, etc) and data format.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remapping the Visual Field to Aid Reading With Central Scotomas
- ClinicalTrials.gov ID
- NCT03848663
- Acronym / sponsor ID
- REMAP002
- Conditions
- Age-related Macular Degeneration
- Keywords
- Scotoma, Remapping, Reading, Low vision, Visual aid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Feb 2019 (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.
Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field.
Detailed description
Following initial characterization of their visual field loss, the participant's performance in reading tasks will be measured with and without remapping. Tasks will include reading groups of random letters, words, simple sentences, and "natural" text from the environment (taken from phone apps, signage, etc). Different kinds of remappings will be used by participants, including traditional and personalized remapping. For control observers, differently shaped artificial scotomas will be used.
Participants interested in the study will be brought in for an initial visit. All participants will be administered the MMSE. Observers who pass the criteria for the study will then have the remainder of the procedures described to them verbally prior to undergoing the remainder of the consent process (see below). Participants will then undergo a standard exam at the UMN eye clinic, if they have not had one within the last month.
Participants will then have their scotomas mapped using a microperimeter housed in the psychology department to give size and shape information. Additional perimetry may also be conducted using either of the two displays (either HMD or desk mounted computer monitor) we have developed. Here, patients will be asked to fixate at a spot on screen and identify visual stimuli presented at different regions of the screen. The size and locations of visual stimuli patients were unable to identify will provide the size and location of the scotoma. Another additional manual perimetry protocol may be conducted as well. This would involve asking subjects to fixate at the center of a tangent screen, and asking them to identify dots temporarily presented on the screen by the researcher using a laser pointer. The locations of dots that patients are unable to identify will provide the size and location of the scotoma. The location and extent of each eye's scotoma and PRL will be used as software inputs on either device. Perimetry using one or all of the methods above will be performed until acceptable information about the scotoma extent and location is obtained.
In a second visit, participants will perform the visual tasks that are used as the basis of their personalized remapping, letter perimetry. Participants will first view and report three randomly selected horizontally arranged letters placed at different locations in the visual field. This letter perimetry task will take about 40 min and will cover a large part of the visual field.
Participants will then read single words whose letters have been displaced from horizontal in various ways that comprise candidate remappings generated on the basis of the letter perimetry results. This personalization test will take about 40 minutes, and will find a good remapping strategy for the individual. Subjects will then be introduced to the reading tasks that comprise the remainder of the study
In 6 additional sessions, participants will perform various reading tasks using different remappings. In all of these, text will be displayed on the screen, and the task is simply to read aloud what was presented. Two sessions will involve reading single words, one session will involve reading strings of 3 letters that are not arranged horizontally, two sessions will involve reading short sentences, and one session will involve reading naturalistic text (from phone apps, signage, menus, etc). In all sessions, some reading will be with remapping, some will be without. Both traditional and personalized remapping will be used.
In all these sessions, the eye tracker will be calibrated to participants' individual head and eye position. This will involve fixating at different points on the device screen (HMD or desk-mounted) as the eye is imaged by the eye trackers. This may take up to 45 minutes in the initial session, if various combinations of head and eye positions are required for the eye trackers to work well. But once completed, calibration is much faster in subsequent sessions. Quick perimetry validation may also be conducted in each session.
Throughout all testing, patients will be asked if they feel any discomfort, and will be able to take a break or quit testing at any point.
Including the initial visit, testing for any given patient is anticipated to last no more than eight sessions over eight weeks. Enrolling participants, testing, and data analysis for all participants is anticipated to take five years from the date of enrollment of the first participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with scotoma | Experimental | Behavioral: Traditional Remapping, Behavioral: Personalized RemappingNo remapping (control condition), traditional remapping, personalized remapping |
| Normally sighted with artificial scotoma | Active comparator | Behavioral: Traditional Remapping, Behavioral: Personalized RemappingNo remapping (control condition), traditional remapping, personalized remapping |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 16 years or older
- Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
- Stable fixation (+/- 1 deg) using their PRL.
- No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
- Satisfactory calibration achievable using eye tracker
Key exclusion criteria (4 listed)
- Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
- Poor fixation (worse than+/- 1 deg) using their PRL.
- Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
- Satisfactory calibration not achievable using eye tracker
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 |
|---|---|---|
| Traditional RemappingShifting text outside of scotoma | Behavioural | Normally sighted with artificial scotoma, Patients with scotoma |
| Personalized RemappingShifting text based on individual letter-based perimetry | Behavioural | Normally sighted with artificial scotoma, Patients with scotoma |
Primary outcome
Reading Speed for Individual Words
Time frame: Measured during third visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
How quickly participants can correctly read displayed text
Reading Speed for Sentences
Time frame: Measured during fourth visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
How quickly participants can correctly read displayed text
Reading Speed for Natural Text Samples
Time frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
How quickly participants can correctly read displayed text
Reading error rate for Individual Words
Time frame: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
How many mistakes participants make
Reading error rate for Sentences
Time frame: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
How many mistakes participants make
Reading error rate for Natural Text Samples
Time frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
How many mistakes participants make
5 secondary outcomes
Eye fixation quality for words
Time frame: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye fixation quality for sentences
Time frame: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye movement quality for sentences
Time frame: Measured during fourth visit
Eye fixation quality for natural text samples
Time frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
Eye movement quality for natural text samples
Time frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day
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 8 Jul 2026.
- Individual participant dataSharing planned: Yes. Perimetry, psychophysical and eye-tracking data will be deidentified upon acquisition, and indexed using only a subject code. These data will be stored on a secure server for sharing upon request by a PI of a research team. We will offer psychophysical and eye tracking data along with appropriate metadata specifying details of the test (remapping used, stimulus protocol, etc) and data format.
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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.
Gordon Legge, Ph.D. contact
Stephen Engel, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Remapping and Personalized Remapping in people with Age-related Macular Degeneration, run by University of Minnesota 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 5 inclusion and 4 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 8 Jul 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 Stephen Engel, Ph.D. (612-625-5571, engel@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading Speed for Individual Words (time frame: Measured during third visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day). The study lists 6 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 8 Jul 2026.