Cone-Rod DegenerationPhase 1NCT04289571
Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
A Phase 1 study testing VR Mobility Tool in people with Cone-Rod Degeneration and Rod-Cone Degeneration, run by National Eye Institute (NEI) at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Cone-Rod Degeneration, Rod-Cone Degeneration
- What is being tested?
- VR Mobility Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jul 2023to 31 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 5 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be eligible, the following inclusion criteria must be met.
- For the NEI site: Participant must be five years of age or older.
- For the USyd site: Participant must be thirteen (13) years of age or older.
- Participant (or legal guardian) must understand and be willing to sign the protocol s informed consent document.
- Participant must be able to cooperate with the testing required for this study.
- Participant must be able to read and speak English.
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- If participant is a minor, their parent or legal guardian must be able to read and speak English.
- For healthy volunteers only:
- Participant must not have retinal disease in either eye.
Who cannot join
- A participant is not eligible if any of the following exclusion criteria are present.
- Participant is in another investigational study and actively receiving study therapy.
- Participant is unable to comply with study procedures.
- STUDY EYE ELIGIBILITY CRITERIA:
- The participant must have at least one eye meeting all inclusion criteria.
- STUDY EYE INCLUSION CRITERIA:
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- Healthy Volunteers Only
- Study eye must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens).
- Participants with Retinal Disease Only
- Study eye must have retinal disease, defined as retinal dysfunction and/or degeneration as previously established by standard clinical methods including perimetry, ERG and imaging.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
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.
Read more
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 or sit in front of a screen 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....
Read the 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 and/or 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 (e.g., 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 (N=45) 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 (e.g., 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 (e.g., 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 (e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s. A secondary outcome is to examine the correlation between the VR mobility test parameters and clinical measures of retinal structure and function (e.g., 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 (e.g., number of hours, type of games played, computer game platform) influences baseline performance on the VR mobility tool.
- Conditions
- Cone-Rod Degeneration, Rod-Cone Degeneration
- Being tested
- VR Mobility Tool
- Keywords
- Cone-Rod Degeneration, Rod-Cone Degeneration, Eye, BCVA, OCT
- Medical subject headings
- Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Mobility ToolDiagnostic test
Participant wears VR goggles and interacts with a visual avatar via a control unit to navigate four courses. Derived parameters automatically recorded by the VR system include number and type of collisions, walking speed, task time, and distance walked.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants with retinal disease, healthy volunteers Receives: Diagnostic Test: VR Mobility Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Examine the correlation between VR mobility test parameters(e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s.
Measured: Three months
Secondary outcomes (6)
Determination of the brightest background at which participants who experience photoaversion can navigate the VR maze.
Determining the brightest background at which participants who experience photoaversion can navigate the VR maze.
Measured: Three months
Sensitivity of VR mobility test parameters to the presence and severity of retinal disease.
Determining the sensitivity of VR mobility test parameters to the presence and severity of retinal disease.
Measured: Three Months
Learning effect on and test-retest variability of the VR test parameters.
Quantifying the learning effect on and testretest variability of the VR test parameters.
Measured: Three Months
Effect of prior game play
Determining whether prior or present computer game playing (e.g., number of hours, type of games played, computer game platform) influences baseline performance on the VR mobility tool.
Measured: Three Months
Feasibility of the tool
Determining the feasibility of the tool based on age and presence of physical disabilities.
Measured: Three Months
Correlation between the VR mobility test parameters and clinical measures of retinal structure and function (e.g., visual acuity, non-seeing area)
Determining the correlation between VR mobility test parameters and clinical measures of retinal structure and function.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Jul 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cone-Rod DegenerationStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brett G Jeffrey, Ph.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289571
- Sponsor's protocol ID
- 200026
- Other IDs
- 20-EI-0026
- Status last verified
- 6 Aug 2026
- First submitted
- 27 Feb 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cross-Sectional Study of Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease
- ClinicalTrials.gov ID
- NCT04289571
- Acronym / sponsor ID
- 200026
- Conditions
- Cone-Rod Degeneration, Rod-Cone Degeneration
- Keywords
- Cone-Rod Degeneration, Rod-Cone Degeneration, Eye, BCVA, OCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 or sit in front of a screen 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 and/or 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 (e.g., 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 (N=45) 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 (e.g., 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 (e.g., 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 (e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s. A secondary outcome is to examine the correlation between the VR mobility test parameters and clinical measures of retinal structure and function (e.g., 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 (e.g., number of hours, type of games played, computer game platform) influences baseline performance on the VR mobility tool.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Diagnostic Test: VR Mobility ToolParticipants with retinal disease, healthy volunteers |
Who may qualify
- Ages
- 5 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- To be eligible, the following inclusion criteria must be met.
- For the NEI site: Participant must be five years of age or older.
- For the USyd site: Participant must be thirteen (13) years of age or older.
- Participant (or legal guardian) must understand and be willing to sign the protocol s informed consent document.
- Participant must be able to cooperate with the testing required for this study.
Key exclusion criteria (10 listed)
- A participant is not eligible if any of the following exclusion criteria are present.
- Participant is in another investigational study and actively receiving study therapy.
- Participant is unable to comply with study procedures.
- The participant must have at least one eye meeting all inclusion criteria.
- Healthy Volunteers Only
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 |
|---|---|---|
| VR Mobility ToolParticipant wears VR goggles and interacts with a visual avatar via a control unit to navigate four courses. Derived parameters automatically recorded by the VR system include number and type of collisions, walking speed, task time, and distance walked. | Diagnostic test | Participants |
Primary outcome
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
Time frame: Three months
Examine the correlation between VR mobility test parameters(e.g., accuracy, task time) and the mobility score from a PRO questionnaire/s.
6 secondary outcomes
Determination of the brightest background at which participants who experience photoaversion can navigate the VR maze.
Time frame: Three months
Sensitivity of VR mobility test parameters to the presence and severity of retinal disease.
Time frame: Three Months
Learning effect on and test-retest variability of the VR test parameters.
Time frame: Three Months
Effect of prior game play
Time frame: Three Months
Feasibility of the tool
Time frame: Three Months
Correlation between the VR mobility test parameters and clinical measures of retinal structure and function (e.g., visual acuity, non-seeing area)
Time frame: Three Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Brett G Jeffrey, Ph.D. principal investigator
National Eye Institute (NEI)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VR Mobility Tool in people with Cone-Rod Degeneration and Rod-Cone Degeneration, run by National Eye Institute (NEI) at 2 sites in 2 countries.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel W Claus, R.N. ((301) 451-1621, daniel.claus@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Three months). 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 Aug 2026.