AmblyopiaNCT06049459
Novel Amblyopia Treatment With Virtual Reality Games
A study testing Optical Correction and Therapeutic Dichoptic Virtual Reality Games in people with Amblyopia, run by Marjean Kulp at 1 site in United States.
Trial summary
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Optical Correction and Therapeutic Dichoptic Virtual Reality Games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients ages 5 to 17 years of age
- Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
- Age normal VA in the nonamblyopic eye
- Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
- Interocular difference of ≥ 3 lines
- No amblyopia treatment in the past 2 weeks
- An interpupillary distance of 52-72 mm (inclusive)
Who cannot join
- Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Previous dichoptic treatment > 2 weeks in duration
- Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
- Diplopia more than once per week over the last week prior to enrollment by parental report.
- Down syndrome or cerebral palsy.
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- Light-induced seizures
- Known simulator sickness
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University College of Optometry
Columbus, Ohio, 43210
Marjean T Kulp, OD, MS, 614-688-3336, kulp.6@osu.edu
About this study
Official title: Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:
Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?
Read more
Participants will each serve as their own control and complete:
Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction
- Conditions
- Amblyopia
- Being tested
- Optical Correction, Therapeutic Dichoptic Virtual Reality Games
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical CorrectionDevice
Optical correction (if needed)
Therapeutic Dichoptic Virtual Reality GamesDevice
Virtual Reality Game play for amblyopia treatment
| Study group | Role | What they receive |
|---|---|---|
| Optical Correction alone | Active comparator | Optical correction alone (16 weeks) (Each participant will complete both study conditions.) Receives: Device: Optical Correction |
| Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction | Experimental | Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.) Receives: Device: Optical Correction; Device: Therapeutic Dichoptic Virtual Reality Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mean Change in Amblyopic Eye Visual Acuity
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Secondary outcomes (6)
Difference in Change in Stereoacuity/Binocularity
Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in Attention
Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing.
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in reading eye movements
Optical correction worn for testing with Readalyzer eye tracker.
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in visual-motor integration
Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)
Measured: Baseline to 16 weeks versus 16 weeks to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start14 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a within-subject study, and all participants complete both study conditions. Each participant completes 16 weeks of optical correction alone (if needed) followed by 16 weeks of Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction. Each subject serves as their own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marjean Kulp
- Sponsor type
- University, hospital or other
- Collaborators
- Beta Sigma Kappa - College of Optometrists in Vision Development, VividVision
- Responsible party
- Sponsor-investigator, Marjean Kulp, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049459
- Sponsor's protocol ID
- 2023H0013
- Status last verified
- Jul 2025
- First submitted
- 15 Sep 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
- ClinicalTrials.gov ID
- NCT06049459
- Acronym / sponsor ID
- 2023H0013
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Marjean KulpUniversity, hospital or other
- Collaborators
- Beta Sigma Kappa - College of Optometrists in Vision Development, VividVision
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Sep 2023 (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 goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:
Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?
Participants will each serve as their own control and complete:
Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a within-subject study, and all participants complete both study conditions. Each participant completes 16 weeks of optical correction alone (if needed) followed by 16 weeks of Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction. Each subject serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Optical Correction alone | Active comparator | Device: Optical CorrectionOptical correction alone (16 weeks) (Each participant will complete both study conditions.) |
| Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction | Experimental | Device: Optical Correction, Device: Therapeutic Dichoptic Virtual Reality GamesTherapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients ages 5 to 17 years of age
- Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd
- Age normal VA in the nonamblyopic eye
- Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
- Interocular difference of ≥ 3 lines
Key exclusion criteria (9 listed)
- Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Previous dichoptic treatment > 2 weeks in duration
- Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).
- Diplopia more than once per week over the last week prior to enrollment by parental report.
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 |
|---|---|---|
| Optical CorrectionOptical correction (if needed) | Device | Optical Correction alone, Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction |
| Therapeutic Dichoptic Virtual Reality GamesVirtual Reality Game play for amblyopia treatment | Device | Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction |
Primary outcome
Difference in Mean Change in Amblyopic Eye Visual Acuity
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older
6 secondary outcomes
Difference in Change in Stereoacuity/Binocularity
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in Attention
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in reading eye movements
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in visual-motor integration
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
Time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks
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 22 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Correction and Therapeutic Dichoptic Virtual Reality Games in people with Amblyopia, run by Marjean Kulp 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 7 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. 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?
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 Marjean T Kulp, OD, MS (614-688-3336, kulp.6@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Mean Change in Amblyopic Eye Visual Acuity (time frame: Baseline to 16 weeks versus 16 weeks to 32 weeks). 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 22 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.