AmblyopiaNCT02003235
Assessment of Device for Treatment of Amblyopia
A study testing Daily watching videos using Reviview™, a dichoptic video display device, for 60 min in people with Amblyopia, run by Visior Technologies Ltd. at 1 site in Israel.
Trial summary
The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids. The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to 15 Jul 2017
- Phase
- Interventional
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Refractive or Strabismic Amblyopia, with best corrected visual acuity.
- Refractive Amblyopia, visual acuity score <6:15 (worse then)
- or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30
Who cannot join
- Diagnosed with epilepsy, recently treated with occlusion or penalization therapy
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.
The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.
- Conditions
- Amblyopia
- Being tested
- Daily watching videos using Reviview™, a dichoptic video display device, for 60 min
- Keywords
- Amblyopia
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily watching videos using Reviview™, a dichoptic video display device, for 60 minDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Daily watching videos using Reviview™, a dichoptic video display device Receives: Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in VA in amblyopic eye
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visior Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haim Stolovitch, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003235
- Sponsor's protocol ID
- RV-TMSC-1
- Status last verified
- Jul 2017
- First submitted
- 1 Dec 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Device for Treatment of Amblyopia
- ClinicalTrials.gov ID
- NCT02003235
- Acronym / sponsor ID
- RV-TMSC-1
- Conditions
- Amblyopia
- Keywords
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Visior Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 6 Dec 2013 (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.
The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.
The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 minDaily watching videos using Reviview™, a dichoptic video display device |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Refractive or Strabismic Amblyopia, with best corrected visual acuity.
- Refractive Amblyopia, visual acuity score <6:15 (worse then)
- or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30
Key exclusion criteria (1 listed)
- Diagnosed with epilepsy, recently treated with occlusion or penalization therapy
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 |
|---|---|---|
| Daily watching videos using Reviview™, a dichoptic video display device, for 60 min | Device | Single Arm |
Primary outcome
Improvement in VA in amblyopic eye
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Haim Stolovitch, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily watching videos using Reviview™, a dichoptic video display device, for 60 min in people with Amblyopia, run by Visior Technologies Ltd. at 1 site in Israel.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in VA in amblyopic eye (time frame: 3 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 21 Jul 2017.