NCT03640130

Brief Summary

The purpose of this study is to evaluate reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. Participants will read a page of text at a comfortable rate. Several manipulations hypothesized to improve reading will be tested, such as an inverted-text "spotlight" of a single word that follows the participant's gaze.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

August 19, 2018

Last Update Submit

November 13, 2018

Conditions

Central Visual Impairment

Outcome Measures

Primary Outcomes (3)

  • Reading speed

    Average time/word it takes to read a paragraph of text.

    From enrollment to completion of testing (<2 weeks)

  • Reading accuracy

    Ability to correctly answer comprehension questions or orally read words

    From enrollment to completion of testing (<2 weeks)

  • Efficiency of eye movement

    Ability to move the eyes systematically from word to word

    From enrollment to completion of testing (<2 weeks)

Study Arms (1)

Single Arm

EXPERIMENTAL

Each participant will participate in several blocks (randomized order), to evaluate performance with and without behavioral gaze-contingent text enhancements.

Behavioral: Gaze-contingent text enhancement

Interventions

Gaze-contingent text enhancementBEHAVIORAL

In different testing blocks, the efficacy of the different enhancements will be evaluated, such as inverting the text in a gaze-contingent inverted "spotlight."

Single Arm

Eligibility Criteria

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

You may qualify if:

  • Normal vision
  • English language

You may not qualify if:

  • Less than 20/20 vision in either eye
  • Abnormalities which affect vision (amblyopia, keratoconus, etc.)
  • Ortho-K lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston, College of Optometry

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

BlindnessVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2018

First Posted

August 21, 2018

Study Start

November 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)