NCT04957745

Brief Summary

In this research study we want to test how people understand a visual scene when the same image is presented to both the eyes, but portions of these images are altered in terms of contrast, depth or in some cases motion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 28, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 9, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 28, 2021

Results QC Date

March 13, 2023

Last Update Submit

June 16, 2023

Conditions

Keywords

Visual confusionRivalryHead mounted displayStereoscopic displaysBinocular vision

Outcome Measures

Primary Outcomes (1)

  • Percentage of Total Viewing Time That Peripheral Target is Perceived

    (Total time the peripheral target in the visual confusion condition was visible) / (total viewing time (=1 min))

    Approximately 1-2 sessions to finish total 6 trials, up to 2 hours for each session, any time within the 4month study period

Study Arms (1)

Visual confusion

EXPERIMENTAL

Participants viewed peripheral targets in three different visual confusion conditions (three interventions): binocular visual confusion (unilateral opaque target), unilateral monocular visual confusion (unilateral see-through target), and bilateral monocular visual confusion (bilateral see-through target). Each intervention was presented twice in a randomized order, resulting in a total of six trials. During each trial, a peripheral target was presented in front of a forward-moving background for one minute. Participants were instructed to hold down the controller button while the target was visible and release it when a third or more of the target disappeared. After each trial, participants could take a brief break before the next trial in a different visual confusion condition was presented in a randomized order.

Behavioral: Binocular visual confusion (unilateral opaque)Behavioral: Unilateral monocular visual confusion (unilateral see-through)Behavioral: Bilateral monocular visual confusion (bilateral see-through)

Interventions

The peripheral target was a horizontally drifting grating measuring 10° by 10°, with a spatial frequency of 1 cycle per degree and a temporal frequency of 3 Hz, and located at 10° above the fixation. For the binocular visual confusion condition, the non-transparent (opaque) peripheral target will be displayed on only one eye (unilateral opaque display).

Visual confusion

The peripheral target was a horizontally drifting grating measuring 10° by 10°, with a spatial frequency of 1 cycle per degree and a temporal frequency of 3 Hz, and located at 10° above the fixation. For the unilateral monocular visual confusion condition, the half-transparent peripheral target will be displayed on only one eye (unilateral see-through display).

Visual confusion

The peripheral target was a horizontally drifting grating measuring 10° by 10°, with a spatial frequency of 1 cycle per degree and a temporal frequency of 3 Hz, and located at 10° above the fixation. For bilateral monocular visual confusion condition, the half-transparent peripheral target will be displayed on both eyes (bilateral see-through display).

Visual confusion

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Better than 20/40 visual acuity in the worse eye
  • No restrictions of the peripheral visual field: (at least 60 degrees vertically and 40 degrees horizontally)
  • At least 14 years of age (no upper age limit)
  • Able to give voluntary, informed consent
  • Able to understand English
  • Binocular vision parameters within normal limits (Stereopsis ≤ 100 arc sec on any stereo test)

You may not qualify if:

  • Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
  • Being unable to complete sessions lasting 2-3 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diplopia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Jaehyun Jung
Organization
Schepens Eye Research Institute of Massachusetts Eye and Ear

Study Officials

  • JaeHyun Jung

    Schepens Eye Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants in the group will see all three interventions (peripheral targets in three visual confusion conditions) in a randomized order. In this study design, each participant will serve as their own control, and the order of the interventions will be randomized to account for potential carryover or ordering effects. There will be no comparison or control group. The outcome will be compared through a within-subject analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 12, 2021

Study Start

November 9, 2021

Primary Completion

July 27, 2022

Study Completion

July 27, 2022

Last Updated

July 10, 2023

Results First Posted

July 10, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations