NCT07216924

Brief Summary

Reading performance in patients with Central Vision Loss will be measured with and without missing text being remapped to different parts of the visual field in a variety of different reading tasks.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
72mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 15, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2031

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

4.9 years

First QC Date

September 22, 2025

Last Update Submit

October 13, 2025

Conditions

Keywords

ReadingCentral Field Loss

Outcome Measures

Primary Outcomes (6)

  • Sentence reading speed

    Time it took to read sentence in words per minute

    Measured on day 35, end of the Personalised Remapping Training in the 33 participants in the Perceptual Learning arm.

  • Sentence reading accuracy

    Percentage of correctly read words in sentence

    Measured on day 35, end of the Personalised Remapping Training in the 33 participants in the Perceptual Learning arm.

  • Word reading speed: RSVP

    Time taken to read each word

    Measured on day 21, end of the RSVP Remapping intervention in the 33 participants in the Rapid Serial Visual Presentation arm.

  • Word recognition accuracy: RSVP

    Percentage of words correctly read

    Measured on day 21, end of the RSVP Remapping intervention in the 33 participants in the Rapid Serial Visual Presentation arm.

  • Word reading speed: Reading in The Wild

    Time taken to read each word

    Measured on day 21, end of the Reading Text in The Wild with Remapping intervention in the 33 participants in the Reading in The Wild arm.

  • Word recognition accuracy: Reading in the wild

    Percentage of words correctly read

    Measured on day 21, end of the Reading Text in The Wild with Remapping intervention in the 33 participants in the Reading in The Wild arm.

Study Arms (3)

Perceptual Learning

EXPERIMENTAL

Participants will practice reading with remapping over many sessions on different days.

Behavioral: Personalised Remapping Training

Rapid Serial Visual Presentation

EXPERIMENTAL

Participants will read words presented one at a time in rapid succession near fixation.

Behavioral: RSVP personalized remappi

Reading in The Wild

EXPERIMENTAL

Participants will view scenes in virtual reality showing natural settings and read a single word at a time within those scenes- e.g. a name on a street sign or shop in a city scene.

Behavioral: Reading text in the wild with remapping

Interventions

Participants will receive training across multiple days with text being shifted in real time as it is being read from locations covered by scotoma to locations determined by personalization procedure .

Perceptual Learning

Participants will read one word at a time presented in rapid succession at fixation with text being shifted from scotoma locations to locations determined by personalization procedure.

Rapid Serial Visual Presentation

Participants will read short texts presented in natural scenes in virtual reality with text being shifted from scotoma locations to locations determined by personalization procedure.

Reading in The Wild

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dense bilateral scotomas of at least 2 deg diameter in each eye covering the fovea
  • Bivariate contour ellipse area (BCEA) of less than 10\^2 is obtained in a simple fixation task

You may not qualify if:

  • Neovascular AMD
  • Any history of visual disorders other than that causing the central vision loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Edina, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Macular DegenerationBlindness, Cortical

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesBlindnessVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Stephen A Engel, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 15, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2032

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Psychophysical (behavioral) data on reading will be gathered from 32 participants each in 3 experiments. Scotoma shape and location and location used for fixation will also be gathered for each participant. All data will be deidentified prior to storage in the repository.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be made available at the end of funding, or upon result publication, whichever comes first. As noted above all relevant publications will contain the DOI that points to the relevant data. The data will be stored as long as the OSF repository remains viable; if for some reason alternative storage sites are required within the next 10 years, the PI will pick from others available and transfer the data there.
Access Criteria
We will store data on the Open Science Foundation (OSF) repository, available to most people. Computer code will be mirrored there and also stored as github repositories. We will take and store separate "snapshots" corresponding to published protocols and analyses to insure accessibility of older code as projects continue to develop. OSF allows for the creation of a DOI for projects, and a project/DOI pair will be created and associated with each aim of the present proposal. The DOI will be referenced in publications and presentations associated with each project. The behavioral data will be stored in a general purpose format (e.g. csv files), but posted analysis and presentation code will make use of MATLAB. While MATLAB is commercial software, most universities have site licenses available. The analysis code may also run in Octave, an open-source alternative to MATLAB.

Locations