AmblyopiaPhase 1NCT02246556
Dichoptic Virtual Reality Therapy for Amblyopia in Adults
A Phase 1 study testing Dichoptic therapy, Patching therapy and Dioptic (non-dichoptic) therapy in people with Amblyopia and Anisometropia, run by University of California, San Francisco at 1 site in United States.
Trial summary
This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Amblyopia, Anisometropia, Strabismus
- What is being tested?
- Dichoptic therapy, Patching therapy and Dioptic (non-dichoptic) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2016
- Phase
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Interpupillary distance of 60-66 mm
- Age 15-40
- Anisometropic amblyopia or strabismic amblyopia
- Best corrected visual acuity of 20/30 or worse in the amblyopic eye
- No prior therapeutic use of the software
- No other ongoing therapies including patching or recent eye muscle surgery
- No vested interest in the product
- Ability attend visits and complete the training session, and to stop the intervention after the specified intervention period
Who cannot join
- Stimulus-deprivation amblyopia.
- Organic lesions of the eye preventing the establishment of good vision (eg. media opacities, abnormalities in the fundus or optic nerve).
- Lesions of the brain preventing the establishment of good vision (eg. cortical visual impairment).
- Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
- Patients diagnosed with Photosensitive Epilepsy.
- Inability to comply with the follow-up visits required.
- History of pathologic nystagmus (congenital or sensory).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94117
About this study
This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.
- Conditions
- Amblyopia, Anisometropia, Strabismus
- Being tested
- Dichoptic therapy, Patching therapy, Dioptic (non-dichoptic) therapy
- Keywords
- Amblyopia, Dichoptic, Virtual reality, Stereopsis, Stereo vision, Visual acuity, Binocular
- Medical subject headings
- Amblyopia, Anisometropia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dichoptic therapyDevice
Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system
Patching therapyOther
Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
Dioptic (non-dichoptic) therapyDevice
Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
| Study group | Role | What they receive |
|---|---|---|
| Patching therapy | Active comparator | Patching treatment followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system. Receives: Other: Patching therapy |
| Dioptic (non-dichoptic) therapy | Active comparator | Dioptic (non-dichoptic) therapy followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system. Receives: Device: Dioptic (non-dichoptic) therapy |
| Dichoptic therapy | Experimental | Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system. Receives: Device: Dichoptic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Measured: 3 weeks, 6 weeks, and 6 months
Secondary outcomes (2)
Change in stereopsis
Measured: 3 weeks, 6 weeks, and 6 months
Quality of life
Measured: 3 weeks, 6 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Recruitment inadequate and investigators leaving the study institution for new positions.
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Levin, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246556
- Sponsor's protocol ID
- 14-14212
- Other IDs
- 093955
- Status last verified
- May 2017
- First submitted
- 17 Sep 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichoptic Virtual Reality Therapy for Amblyopia in Adults
- ClinicalTrials.gov ID
- NCT02246556
- Acronym / sponsor ID
- 14-14212
- Conditions
- Amblyopia, Anisometropia, Strabismus
- Keywords
- Amblyopia, Dichoptic, Virtual reality, Stereopsis, Stereo vision, Visual acuity, Binocular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment inadequate and investigators leaving the study institution for new positions.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Sep 2014 (estimated)
- 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.
This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patching therapy | Active comparator | Other: Patching therapyPatching treatment followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system. |
| Dioptic (non-dichoptic) therapy | Active comparator | Device: Dioptic (non-dichoptic) therapyDioptic (non-dichoptic) therapy followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system. |
| Dichoptic therapy | Experimental | Device: Dichoptic therapyDichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Interpupillary distance of 60-66 mm
- Age 15-40
- Anisometropic amblyopia or strabismic amblyopia
- Best corrected visual acuity of 20/30 or worse in the amblyopic eye
- No prior therapeutic use of the software
Key exclusion criteria (7 listed)
- Stimulus-deprivation amblyopia.
- Organic lesions of the eye preventing the establishment of good vision (eg. media opacities, abnormalities in the fundus or optic nerve).
- Lesions of the brain preventing the establishment of good vision (eg. cortical visual impairment).
- Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
- Patients diagnosed with Photosensitive Epilepsy.
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 |
|---|---|---|
| Dichoptic therapyDichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system | Device | Dichoptic therapy |
| Patching therapyConventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software | Other | Patching therapy |
| Dioptic (non-dichoptic) therapyDioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software | Device | Dioptic (non-dichoptic) therapy |
Primary outcome
Change in visual acuity
Time frame: 3 weeks, 6 weeks, and 6 months
2 secondary outcomes
Change in stereopsis
Time frame: 3 weeks, 6 weeks, and 6 months
Quality of life
Time frame: 3 weeks, 6 weeks, and 6 months
Results and safety
The study was stopped early (reason given: Recruitment inadequate and investigators leaving the study institution for new positions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dichoptic therapy, Patching therapy and Dioptic (non-dichoptic) therapy in people with Amblyopia and Anisometropia, run by University of California, San Francisco 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 May 2017. 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.
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?
The study was stopped early (reason given: Recruitment inadequate and investigators leaving the study institution for new positions.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity (time frame: 3 weeks, 6 weeks, and 6 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 3 May 2017.