Convergence InsufficiencyEarly Phase 1VRVT - VERVENCT04691427
Effectiveness of Virtual Reality Vision Therapy - VERVE
A Early Phase 1 study testing Virtual Eye Rotation Vision Exercises (VERVE) in people with Convergence Insufficiency, run by OculoMotor Technologies at 2 sites in United States.
Trial summary
The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. Read more about this study
- Who is it for?
- Ages 9 to 35 years
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Virtual Eye Rotation Vision Exercises (VERVE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2021to Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 9 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 9 years and older
- CISS score ≥ 16
- Best-corrected distance visual acuity of 20/25 or better in each eye
- Random dot stereopsis appreciation of 500 seconds of arc or better
- Parent or subject understands the protocol and is willing to enroll in the study
Who cannot join
- Constant strabismus at distance or near
- Vertical heterophoria ≥ 2 ∆ at distance or near
- ≥ 2 line interocular difference in best-corrected visual acuity
- Near point of accommodation > 20 cm in either eye as measured by push-up method
- Manifest or latent nystagmus
- Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain
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- Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease
- Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
- Inability to comprehend and/or perform any study-related test or procedure
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
OculoMotor Technologies
Newark, New Jersey, 07103
Chang Yaramothu, PhD, cto@omtvr.com
- Completed
The Eye Institute at Salus University
Philadelphia, Pennsylvania, 19141
About this study
Official title: Effectiveness of Vision Therapy in a Virtual Reality Headset
The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.
- Conditions
- Convergence Insufficiency
- Being tested
- Virtual Eye Rotation Vision Exercises (VERVE)
- Medical subject headings
- Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Eye Rotation Vision Exercises (VERVE)Device
A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).
| Study group | Role | What they receive |
|---|---|---|
| Active Virtual Reality-Based Vision Therapy | Experimental | Virtual reality vision therapy where participants will be playing a custom-designed video game to act as a therapeutic intervention on a consumer-available virtual reality headset. Receives: Device: Virtual Eye Rotation Vision Exercises (VERVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Fusional Vergence
Normal range is >15 Prism Diopters
Measured: up to 4 weeks post-therapy
Near Point of Convergence
Normal range is < 6 cm
Measured: up to 4 weeks post-therapy
Secondary outcomes (3)
Convergence Insufficiency Symptom Survey (CISS)
Normal range is < 21 for adults and < 16 for pediatrics
Measured: up to 4 weeks post-therapy
Vision Quality of Life with Time Survey (VisQuaL-T)
Normal range is > 2.5
Measured: up to 4 weeks post-therapy
Core Elements of Gaming Experience Questionnaire
User experience rating
Measured: up to 4 weeks post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start14 Oct 2021
- Primary completion28 Aug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convergence InsufficiencyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OculoMotor Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Jersey Institute of Technology, Salus University
- Responsible party
- Sponsor
- Investigators
- Chang Yaramothu, PhD, Study chair, OculoMotor TechnologiesTara L Alvarez, PhD, Principal investigator, OculoMotor TechnologiesMitchell M Scheiman, OD, PhD, Principal investigator, OculoMotor Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691427
- Sponsor's protocol ID
- OMT-01
- Acronym
- VRVT - VERVE
- Status last verified
- Apr 2024
- First submitted
- 15 Dec 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vision Therapy in a Virtual Reality Headset
- ClinicalTrials.gov ID
- NCT04691427
- Acronym / sponsor ID
- VRVT - VERVE / OMT-01
- Conditions
- Convergence Insufficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OculoMotor TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- New Jersey Institute of Technology, Salus University
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 28 Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 31 Dec 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.
The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Virtual Reality-Based Vision Therapy | Experimental | Device: Virtual Eye Rotation Vision Exercises (VERVE)Virtual reality vision therapy where participants will be playing a custom-designed video game to act as a therapeutic intervention on a consumer-available virtual reality headset. |
Who may qualify
- Ages
- 9 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 9 years and older
- CISS score ≥ 16
- Best-corrected distance visual acuity of 20/25 or better in each eye
- Random dot stereopsis appreciation of 500 seconds of arc or better
- Parent or subject understands the protocol and is willing to enroll in the study
Key exclusion criteria (9 listed)
- Constant strabismus at distance or near
- Vertical heterophoria ≥ 2 ∆ at distance or near
- ≥ 2 line interocular difference in best-corrected visual acuity
- Near point of accommodation > 20 cm in either eye as measured by push-up method
- Manifest or latent nystagmus
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 |
|---|---|---|
| Virtual Eye Rotation Vision Exercises (VERVE)A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye). | Device | Active Virtual Reality-Based Vision Therapy |
Primary outcome
Positive Fusional Vergence
Time frame: up to 4 weeks post-therapy
Normal range is >15 Prism Diopters
Near Point of Convergence
Time frame: up to 4 weeks post-therapy
Normal range is < 6 cm
3 secondary outcomes
Convergence Insufficiency Symptom Survey (CISS)
Time frame: up to 4 weeks post-therapy
Vision Quality of Life with Time Survey (VisQuaL-T)
Time frame: up to 4 weeks post-therapy
Core Elements of Gaming Experience Questionnaire
Time frame: up to 4 weeks post-therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- 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.
Chang Yaramothu, PhD study chair
OculoMotor Technologies
Tara L Alvarez, PhD principal investigator
OculoMotor Technologies
Mitchell M Scheiman, OD, PhD principal investigator
OculoMotor Technologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual Eye Rotation Vision Exercises (VERVE) in people with Convergence Insufficiency, run by OculoMotor Technologies at 2 sites 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Yaramothu, PhD (9735585456, cto@omtvr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Fusional Vergence (time frame: up to 4 weeks post-therapy). The study lists 2 primary outcomes in all. 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 16 Apr 2024.