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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Stephen Engel, Ph.D. contact

612-625-5571

engel@umn.edu

Gordon Legge, Ph.D. contact

legge@umn.edu

United States1 site, 1 recruiting
  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Stephen Engel

    Recruiting

Other trials in United States

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.

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 groups in NCT03848663
Study groupRoleWhat they receive
Patients with scotomaExperimentalNo remapping (control condition), traditional remapping, personalized remapping
Receives: Behavioral: Traditional Remapping; Behavioral: Personalized Remapping
Normally sighted with artificial scotomaActive comparatorNo 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)
  1. 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

  2. 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

  3. Eye movement quality for sentences

    Number off leftward (regressive) eye movements during sentence reading

    Measured: Measured during fourth visit

  4. 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

  5. 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.

  1. First posted21 Feb 2019
  2. Study start1 Feb 2022
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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)
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.

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.

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