Amblyopia, AnisometropicNCT02970708
Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia
A study testing EFG group and Patching group in people with Amblyopia, Anisometropic, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Amblyopia, Anisometropic
- What is being tested?
- EFG group and Patching group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged from 4 to 13 years old
- the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes
- anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more.
- no amblyopia treatment one month prior to the study except refractive correction.
- myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
- willing to participate in this study and be able to follow up on time
Who cannot join
- ocular disease and other disease that have an influence on the visual acuity
- history of ocular surgery that have an influence on the visual acuity
- the patient is receiving other amblyopia treatment except refractive correction
- a family or personal history of seizures
- the patient is using some medicine that may have an influence on visual acuity
About this study
Official title: Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children
To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.
Read the detailed description
A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional MRI will be measured at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.
- Conditions
- Amblyopia, Anisometropic
- Being tested
- EFG group, Patching group
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFG groupDevice
88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.
Patching groupDevice
88 anisometropic amblyopia will be recruited to receive patching treatment.
| Study group | Role | What they receive |
|---|---|---|
| EFG group | Experimental | amblyopia in EFG group will receive Eyetronix Flicker Glassess treatment. Receives: Device: EFG group |
| Patching group | Active comparator | amblyopia in patching group will receive patching treatment. Receives: Device: Patching group |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
have an improvement of best corrected visual acuity in the amblyopic eyes
Measured: 6 months
Secondary outcomes (5)
stereocuity
have an improvement of stereocuity in the amblyopic eyes
Measured: 6 months
contrast sensitivity function
have an improvement of contrast sensitivity in the amblyopic eyes
Measured: 6 months
visual evoked potential
P100 latency decrease and N75-P100 amplitude increase in the amblyopic eye.
Measured: 6 months
functional MRI
the visual cortex activity have an improvement
Measured: 6 months
best corrected visual acuity
have an improvement of best corrected visual acuity in the amblyopic eyes
Measured: a year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amblyopia, AnisometropicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970708
- Sponsor's protocol ID
- YFZX2016001
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eyetronix Flicker Glasses to the Treatment of Anisometropic Amblyopia in Chinese Children
- ClinicalTrials.gov ID
- NCT02970708
- Acronym / sponsor ID
- YFZX2016001
- Conditions
- Amblyopia, Anisometropic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Nov 2016 (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.
To evaluate the efficacy and safety of Eyetronix Flicker Glassess therapy in treating anisometropic amblyopia.
Detailed description
A total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or Eyetronix Flicker Glasses treatment in a 1:1 ratio.Eyetronix Flicker Glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. Patching is a traditional treatment of amblyopia. The best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional MRI will be measured at baseline and follow-up visits to assess the improvement of amblyopia.Feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFG group | Experimental | Device: EFG groupamblyopia in EFG group will receive Eyetronix Flicker Glassess treatment. |
| Patching group | Active comparator | Device: Patching groupamblyopia in patching group will receive patching treatment. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- aged from 4 to 13 years old
- the best corrected visual acuity in the amblyopic eye is no more than 0.1logMAR, with two lines or more of difference between the two eyes
- anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 D or more or a cylindrical difference of 1.50 D or more.
- no amblyopia treatment one month prior to the study except refractive correction.
- myopia is less than -6.00D or hyperopia is less than +9.00D, strabismus was less than 20 prism diopters
Key exclusion criteria (5 listed)
- ocular disease and other disease that have an influence on the visual acuity
- history of ocular surgery that have an influence on the visual acuity
- the patient is receiving other amblyopia treatment except refractive correction
- a family or personal history of seizures
- the patient is using some medicine that may have an influence on visual acuity
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 |
|---|---|---|
| EFG group88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment. | Device | EFG group |
| Patching group88 anisometropic amblyopia will be recruited to receive patching treatment. | Device | Patching group |
Primary outcome
best corrected visual acuity
Time frame: 6 months
have an improvement of best corrected visual acuity in the amblyopic eyes
5 secondary outcomes
stereocuity
Time frame: 6 months
contrast sensitivity function
Time frame: 6 months
visual evoked potential
Time frame: 6 months
functional MRI
Time frame: 6 months
best corrected visual acuity
Time frame: a year and a half
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EFG group and Patching group in people with Amblyopia, Anisometropic, run by Shanghai Eye Disease Prevention and Treatment Center.
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 6 inclusion and 5 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
best corrected visual acuity (time frame: 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 22 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.