Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04289571
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2020-02-27
Brief Title:
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
Status:
RECRUITING
Status Verified Date:
2024-08-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
The retina is a thin layer of tissue at the back of the eye Retinal disease usually reduces a person s mobility because it affects how he or she moves through familiar and unfamiliar environments Researchers want to see if a virtual reality VR tool can provide an easier and more accurate way to assess mobility
Objective
To learn if researchers can track changes in mobility in people with retinal disease using a new VR tool
Eligibility
People aged 5 and older with retinal disease that affects their vision and healthy volunteers
Design
Participants will have 2-3 clinic visits
Participants will wear goggles while sitting Using a game controller they will navigate through 4 obstacle courses presented in VR
Participants will have a medical history exam They will answer questions about their family history They will fill out questionnaires about the vision and mobility issues they have in their daily lives
Participants will have a complete eye exam They will read letters from a chart Their eye pressure will be measured Their pupils may be dilated with eye drops Pictures of their eye will be taken Lights will be shined in their eyes
Participants will take a visual field test For this they will look into a dome and press a button when they see a light
Participants will have an electroretinogram For this they will sit in the dark with their eyes patched Then their eyes will be numbed with eye drops and they will wear contact lenses while watching flashing lights
Participants will have optical coherence tomography This is a noninvasive procedure It produces cross-sectional pictures of the retina
The retina is a thin layer of tissue at the back of the eye Retinal disease usually reduces a person s mobility because it affects how he or she moves through familiar and unfamiliar environments Researchers want to see if a virtual reality VR tool can provide an easier and more accurate way to assess mobility
Objective
To learn if researchers can track changes in mobility in people with retinal disease using a new VR tool
Eligibility
People aged 5 and older with retinal disease that affects their vision and healthy volunteers
Design
Participants will have 2-3 clinic visits
Participants will wear goggles while sitting Using a game controller they will navigate through 4 obstacle courses presented in VR
Participants will have a medical history exam They will answer questions about their family history They will fill out questionnaires about the vision and mobility issues they have in their daily lives
Participants will have a complete eye exam They will read letters from a chart Their eye pressure will be measured Their pupils may be dilated with eye drops Pictures of their eye will be taken Lights will be shined in their eyes
Participants will take a visual field test For this they will look into a dome and press a button when they see a light
Participants will have an electroretinogram For this they will sit in the dark with their eyes patched Then their eyes will be numbed with eye drops and they will wear contact lenses while watching flashing lights
Participants will have optical coherence tomography This is a noninvasive procedure It produces cross-sectional pictures of the retina
Detailed Description:
Objective Designing clinical trials for advanced retinal disease represents an especially difficult challenge due to the lack of suitable outcome measures Clinical measures such as visual field and area of atrophy measured with multimodal imaging may be highly variable andor difficult to measure in this population A main contributor to disability in the visually impaired is poor mobility which is a quality of life measure used to assess visually-guided behavior in low-vision patients The goal of our study is to determine whether parameters from a recently developed virtual reality VR mobility assessment tool may serve as biomarkers of functional vision in participants with advanced retinal disease The long-term goal will be to determine whether the VR mobility assessment tool parameters can document longitudinal changes in functional vision and serve as a suitable outcome measure for clinical trials in participants with advanced retinal disease
Study Population Up to 120 participants with retinal disease and 45 healthy volunteers will be recruited The upper limit of 120 participants with retinal disease was chosen to allow approximately equal groups of 60 participants with rod-cone degeneration RCD and 60 participants with cone-rod degeneration CRD to represent groups of participants with peripheral visual field constriction and central vision loss respectively A total of 60 per group was chosen to A allow feasibility to be determined across age groups eg 5-11 yrs 12-50 years over 50 years and B to allow for a sufficient range of disease severity to examine VR mobility test sensitivity The number of healthy volunteers N45 was chosen to provide about 15 participants across each of three age groups
Design In this multi-site observational study VR mobility testing will be performed in participants with retinal disease While the ultimate goal is to use this for advanced retinal disease in the current study we will examine participants with a wide range of retinal disease severity to enable correlations between VR mobility parameters and markers of disease severity eg field size mobility scores from questionnaires This analysis will also help determine the range of retinal disease severity for which VR mobility will be useful Based on the simulation studies we predict that participants should be able to repeat the VR course between four to eight times in a one-hour session Testing will also include best corrected visual acuity BCVA visual fields optical coherence tomography OCT autofluorescence imaging ultra-widefield imaging and participant reported outcome PRO questionnaires Two tests of photosensitivity Visual Photosensitivity Threshold VPT and Palpebral Aperture Measurement PAM will also be recorded in a subset of participants known to be photosensitive eg albinos achromats and CRD and healthy volunteers at visit 001 Participants will be required to attend two to three clinic visits within three months VR and photosensitivity testing will be the focus of the second and third clinic visit in order to A examine the learning effect and B quantify test-retest variability of VR and photosensitivity test parameters
Outcome Measures The primary outcome is to determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease To this end we will examine the correlation between VR mobility test parameters eg accuracy task time and the mobility score from a PRO questionnaires A secondary outcome is to examine the correlation between the VR mobility test parameters and clinical measures of retinal structure and function eg visual acuity non-seeing area Other secondary outcomes include quantifying the learning effect and test-retest variability of the VR test parameters exploring the feasibility of the tool based on age and presence of physical disabilities determining the sensitivity of VR mobility test parameters to the presence and severity of retinal disease determining the brightest background at which participants who experience photoaversion can navigate the VR maze and determining whether prior or present computer game playing eg number of hours type of games played computer game platform influences baseline performance on the VR mobility tool
Study Population Up to 120 participants with retinal disease and 45 healthy volunteers will be recruited The upper limit of 120 participants with retinal disease was chosen to allow approximately equal groups of 60 participants with rod-cone degeneration RCD and 60 participants with cone-rod degeneration CRD to represent groups of participants with peripheral visual field constriction and central vision loss respectively A total of 60 per group was chosen to A allow feasibility to be determined across age groups eg 5-11 yrs 12-50 years over 50 years and B to allow for a sufficient range of disease severity to examine VR mobility test sensitivity The number of healthy volunteers N45 was chosen to provide about 15 participants across each of three age groups
Design In this multi-site observational study VR mobility testing will be performed in participants with retinal disease While the ultimate goal is to use this for advanced retinal disease in the current study we will examine participants with a wide range of retinal disease severity to enable correlations between VR mobility parameters and markers of disease severity eg field size mobility scores from questionnaires This analysis will also help determine the range of retinal disease severity for which VR mobility will be useful Based on the simulation studies we predict that participants should be able to repeat the VR course between four to eight times in a one-hour session Testing will also include best corrected visual acuity BCVA visual fields optical coherence tomography OCT autofluorescence imaging ultra-widefield imaging and participant reported outcome PRO questionnaires Two tests of photosensitivity Visual Photosensitivity Threshold VPT and Palpebral Aperture Measurement PAM will also be recorded in a subset of participants known to be photosensitive eg albinos achromats and CRD and healthy volunteers at visit 001 Participants will be required to attend two to three clinic visits within three months VR and photosensitivity testing will be the focus of the second and third clinic visit in order to A examine the learning effect and B quantify test-retest variability of VR and photosensitivity test parameters
Outcome Measures The primary outcome is to determine whether parameters from a recently developed VR mobility tool can serve as biomarkers of functional vision in participants with retinal disease To this end we will examine the correlation between VR mobility test parameters eg accuracy task time and the mobility score from a PRO questionnaires A secondary outcome is to examine the correlation between the VR mobility test parameters and clinical measures of retinal structure and function eg visual acuity non-seeing area Other secondary outcomes include quantifying the learning effect and test-retest variability of the VR test parameters exploring the feasibility of the tool based on age and presence of physical disabilities determining the sensitivity of VR mobility test parameters to the presence and severity of retinal disease determining the brightest background at which participants who experience photoaversion can navigate the VR maze and determining whether prior or present computer game playing eg number of hours type of games played computer game platform influences baseline performance on the VR mobility tool
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-EI-0026 | None | None | None |