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Visual Remapping to Aid Reading With Field Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03848663
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Behavioral: Traditional Remapping Behavioral: Personalized Remapping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remapping the Visual Field to Aid Reading With Central Scotomas
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with scotoma
No remapping (control condition), traditional remapping, personalized remapping
Behavioral: Traditional Remapping
Shifting text outside of scotoma

Behavioral: Personalized Remapping
Shifting text based on individual letter-based perimetry

Active Comparator: Normally sighted with artificial scotoma
No remapping (control condition), traditional remapping, personalized remapping
Behavioral: Traditional Remapping
Shifting text outside of scotoma

Behavioral: Personalized Remapping
Shifting text based on individual letter-based perimetry




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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 ]
    Variance of x and y eye position coordinates computed during fixation periods while reading

  2. 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 ]
    Variance of x and y eye position coordinates computed during fixation periods while reading

  3. Eye movement quality for sentences [ Time Frame: Measured during fourth visit ]
    Number off leftward (regressive) eye movements during sentence reading

  4. 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 ]
    Variance of x and y eye position coordinates computed during fixation periods while reading

  5. 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 ]
    Number off leftward (regressive) eye movements during natural text reading



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 16 years or older
  2. Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
  3. Stable fixation (+/- 1 deg) using their PRL.
  4. No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
  5. Satisfactory calibration achievable using eye tracker

Exclusion Criteria:

  1. Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
  2. Poor fixation (worse than+/- 1 deg) using their PRL.
  3. Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
  4. Satisfactory calibration not achievable using eye tracker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848663


Contacts
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Contact: Stephen Engel, Ph.D. 612-625-5571 engel@umn.edu
Contact: Gordon Legge, Ph.D. legge@umn.edu

Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Stephen Engel, Ph.D. University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03848663    
Other Study ID Numbers: REMAP002
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Analytic Code
Time Frame: Once results are published.
Access Criteria: Research group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Scotoma
Remapping
Reading
Low vision
Visual aid
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases