NCT03848663

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2022Jul 2026

First Submitted

Initial submission to the registry

January 28, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
2.9 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

January 28, 2019

Last Update Submit

April 16, 2026

Conditions

Keywords

ScotomaRemappingReadingLow visionVisual aid

Outcome Measures

Primary Outcomes (6)

  • Reading Speed for Individual Words

    How quickly participants can correctly read displayed text

    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 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 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 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 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 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

    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

    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

    Measured during fourth visit

  • Eye fixation quality for natural text samples

    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

    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

Study Arms (2)

Patients with scotoma

EXPERIMENTAL

No remapping (control condition), traditional remapping, personalized remapping

Behavioral: Traditional RemappingBehavioral: Personalized Remapping

Normally sighted with artificial scotoma

ACTIVE COMPARATOR

No remapping (control condition), traditional remapping, personalized remapping

Behavioral: Traditional RemappingBehavioral: Personalized Remapping

Interventions

Shifting text outside of scotoma

Normally sighted with artificial scotomaPatients with scotoma

Shifting text based on individual letter-based perimetry

Normally sighted with artificial scotomaPatients with scotoma

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Macular DegenerationScotomaVision, Low

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephen Engel, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Engel, Ph.D.

CONTACT

Gordon Legge, Ph.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 21, 2019

Study Start

February 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Once results are published.
Access Criteria
Research group.

Locations