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Understanding Visual Confusion Using Stereoscopic Displays

Primary Purpose

Diplopia, Binocular Vision Suppression, Binocular; Fusion, With Defective Stereopsis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Binocular visual confusion (unilateral opaque)

Unilateral monocular visual confusion (unilateral see-through)

Bilateral monocular visual confusion (bilateral see-through)

About this trial

This is an interventional basic science trial for Diplopia focused on measuring Visual confusion, Rivalry, Head mounted display, Stereoscopic displays, Binocular vision

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion criteria:

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

Sites / Locations

Schepens Eye Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Visual confusion

Arm Description

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.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

Full Information

NCT ID

NCT04957745

First Posted

June 28, 2021

Last Updated

June 16, 2023

Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

National Eye Institute (NEI)

1. Study Identification

Unique Protocol Identification Number

NCT04957745

Brief Title

Understanding Visual Confusion Using Stereoscopic Displays

Official Title

Monocular Visual Confusion for Field Expansion

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

November 9, 2021 (Actual)

Primary Completion Date

July 27, 2022 (Actual)

Study Completion Date

July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diplopia, Binocular Vision Suppression, Binocular; Fusion, With Defective Stereopsis, Monocular Diplopia

Keywords

Visual confusion, Rivalry, Head mounted display, Stereoscopic displays, Binocular vision

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Visual confusion

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Binocular visual confusion (unilateral opaque)

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Unilateral monocular visual confusion (unilateral see-through)

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Bilateral monocular visual confusion (bilateral see-through)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Percentage of Total Viewing Time That Peripheral Target is Perceived

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JaeHyun Jung

Organizational Affiliation

Schepens Eye Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schepens Eye Research Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Understanding Visual Confusion Using Stereoscopic Displays

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