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| ID | Type | Description | Link |
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| R01EY031777 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binocular visual confusion (unilateral opaque) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JaeHyun Jung | Schepens Eye Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Schepens Eye Research Institute | Boston | Massachusetts | 02114 | United States |
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13 participants were recruited and screened for eligibility and all of them met the inclusion criteria.
13 participants were recruited and screened for eligibility and all of them met the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Visual Confusion | 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. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
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| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2021 |
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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.
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| Unilateral monocular visual confusion (unilateral see-through) | Behavioral | 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). |
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| Bilateral monocular visual confusion (bilateral see-through) | Behavioral | 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). |
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| ID | Title | Description |
|---|---|---|
| BG000 | Visual Confusion | The study participants will respond to various visual confusion stimuli presented on a stereoscopic display designed to simulate binocular/monocular visual confusions Visual confusion: We will show peripheral target images on a background motion in a stereoscopic display. For the binocular visual confusion condition, the target peripheral image will be displayed on only one eye. For unilateral and bilateral monocular visual confusion conditions, the half-transparent peripheral image will be displayed on only one eye and both eyes, respectively. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Visual acuity | The visual acuity test is used to determine the smallest letters that a participant can read on a standardized chart (Snellen chart) held 20 feet away. A Snellen fraction of 20/20 indicates normal vision, where the smallest line of letters on the chart can be read from 20 feet away. For example, 20/40 (worse than normal) vision can see a letter clearly at 20 feet that normal vision could see clearly at 40 feet, while 20/10 (better than normal) vision can see a letter clearly at 20 feet that normal vision could see clearly at 10 feet. We measured visual acuity with both eyes open. | Mean | Standard Deviation | Snellen fraction (20/X) |
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| Stereo-acuity | Stereo acuity refers to the smallest detectable depth difference that can be perceived through binocular vision. It is measured in terms of the angular difference in arcseconds, with smaller values indicating better acuity. The random dot stereogram is commonly used to measure stereoacuity within the range of 20 to 400 arcseconds. In this test, participants are asked to identify which of three circles appears to float forward or seems "different" from the others. If the participant's stereoacuity is better than the target value, they will be able to discern the differences. | Mean | Standard Deviation | arcseconds |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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)) | Each subject observed two trials in each visual confusion condition. There were three visual confusion conditions, so each subject participated in 6 trials. Since 13 subjects participated, the total number of trials analyzed was 78 trials (6 * 13). For each visual confusion condition, 26 trials were analyzed. | Posted | Mean | Standard Deviation | Percentage of Time | Approximately 1-2 sessions to finish total 6 trials, up to 2 hours for each session, any time within the 4month study period | Trials | Trials |
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Through study completion, an average of 4 months, for all three interventions
All participants who saw at least one intervention (peripheral target in any visual confusion condition) were asked to report when they experienced any potential other adverse events (i.e., dizziness, motion sickness, and nausea), but there were no reported other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Visual Confusion | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaehyun Jung | Schepens Eye Research Institute of Massachusetts Eye and Ear | 6179122525 | jaehyun_jung@meei.harvard.edu |
| Nov 23, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2021 | Nov 23, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D004172 | Diplopia |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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