DiplopiaNCT04957745
Understanding Visual Confusion Using Stereoscopic Displays
A study testing Binocular visual confusion (unilateral opaque), Unilateral monocular visual confusion (unilateral see-through) and Bilateral monocular visual confusion (bilateral see-through) in people with Diplopia and Binocular Vision Suppression, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diplopia, Binocular Vision Suppression, Binocular; Fusion, With Defective Stereopsis
- What is being tested?
- Binocular visual confusion (unilateral opaque), Unilateral monocular visual confusion (unilateral see-through) and Bilateral monocular visual confusion (bilateral see-through)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Schepens Eye Research Institute
Boston, Massachusetts, 02114
About this study
Official title: Monocular Visual Confusion for Field Expansion
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.
- Conditions
- Diplopia, Binocular Vision Suppression, Binocular; Fusion, With Defective Stereopsis, Monocular Diplopia
- Being tested
- Binocular visual confusion (unilateral opaque), Unilateral monocular visual confusion (unilateral see-through), Bilateral monocular visual confusion (bilateral see-through)
- Keywords
- Visual confusion, Rivalry, Head mounted display, Stereoscopic displays, Binocular vision
- Medical subject headings
- Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular visual confusion (unilateral opaque)Behavioural
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).
Unilateral monocular visual confusion (unilateral see-through)Behavioural
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).
Bilateral monocular visual confusion (bilateral see-through)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Binocular visual confusion (unilateral opaque); Behavioral: Unilateral monocular visual confusion (unilateral see-through); Behavioral: Bilateral monocular visual confusion (bilateral see-through) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: Approximately 1-2 sessions to finish total 6 trials, up to 2 hours for each session, any time within the 4month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start9 Nov 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiplopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Jaehyun Jung, Massachusetts Eye and Ear Infirmary
- Investigators
- JaeHyun Jung, Principal investigator, Schepens Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957745
- Sponsor's protocol ID
- 2021P001757
- Other IDs
- R01EY031777
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2021
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocular Visual Confusion for Field Expansion
- ClinicalTrials.gov ID
- NCT04957745
- Acronym / sponsor ID
- 2021P001757
- Conditions
- Diplopia, Binocular Vision Suppression, Binocular; Fusion, With Defective Stereopsis, Monocular Diplopia
- Keywords
- Visual confusion, Rivalry, Head mounted display, Stereoscopic displays, Binocular vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Visual confusion | Experimental | Behavioral: Binocular visual confusion (unilateral opaque), Behavioral: Unilateral monocular visual confusion (unilateral see-through), Behavioral: Bilateral monocular visual confusion (bilateral see-through)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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binocular visual confusion (unilateral opaque)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). | Behavioural | Visual confusion |
| Unilateral monocular visual confusion (unilateral see-through)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). | Behavioural | Visual confusion |
| Bilateral monocular visual confusion (bilateral see-through)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). | Behavioural | Visual confusion |
Primary outcome
Percentage of Total Viewing Time That Peripheral Target is Perceived
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
(Total time the peripheral target in the visual confusion condition was visible) / (total viewing time (=1 min))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JaeHyun Jung principal investigator
Schepens Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binocular visual confusion (unilateral opaque), Unilateral monocular visual confusion (unilateral see-through) and Bilateral monocular visual confusion (bilateral see-through) in people with Diplopia and Binocular Vision Suppression, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Total Viewing Time That Peripheral Target is Perceived (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.