AmblyopiaNCT02687581
Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia
A study testing IO-therapy Glasses and patch in people with Amblyopia, run by Salus University at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- IO-therapy Glasses and patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2016to 30 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 to < 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- Visual acuity in the amblyopic eye between 20/100 and 20/400 inclusive
- Visual acuity in the sound eye 20/32 or better
- Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
Show all 14Show fewer
- Requirements for spectacle correction:
- For patients meeting criteria for only strabismus i. Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion.
- For patients meeting criteria for anisometropia or combined-mechanism i. Spherical equivalent must be within 0.50 D of fully correcting the anisometropia ii. Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes iii. Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism iv. Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
- Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
- Gestational age > 34 weeks and birth weight > 1500 grams
- Parent willing to accept randomization
- Parent willing to be contacted and has access to phone
- Parent does not anticipate relocation outside area of active study site
Who cannot join
- • Amblyopic eye has myopia worse than -3.00D spherical equivalent.
- Previous amblyopia treatment within 6 months.
- Prior intraocular or refractive surgery
- Known skin reactions to patch or bandage adhesives
- Systemic diseases that may cause reduced vision such as Down syndrome.
- If patients are in the deprivation amblyopia category, the following criteria must be met for the patient to be enrolled in the study:
Show all 18Show fewer
- Age 3 to < 8 years
- Amblyopia due to previous congenital or developmental cataract surgery.
- Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- Visual acuity in the amblyopic eye between 20/40 and 20/400 inclusive b. Visual acuity in the sound eye 20/32 or better c. Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 3 lines worse than sound eye acuity) d) Gestational age > 34 weeks and birth weight > 1500 grams e) Parent willing to be contacted and has access to phone.
- If patients are enrolled in the myopic anisometropia amblyopia category, the following criteria must be met for the patients to be enrolled in the study.
- Aged 3 to <8 years
- Best-corrected VA in the amblyopic eye of 20/40 to 20/400 inclusive
- Best-corrected VA in the fellow eye of 20/40 or better
- Magnitude of myopic anisometropia of > 3.00 D
- Intereye acuity difference of > 3 logMAR lines
- Amblyopia associated with myopic anisometropia
- Has been wearing optimal spectacle correction for a minimum of four weeks
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.
Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.
The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.
Read the detailed description
Children ages 3 to < 8 years with severe/dense amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.
Children ages 3 to < 8 years with deprivation amblyopia associated with congenital or developmental cataracts (visual acuity of 20/40 to 20/400 in the amblyopic eye) will be enrolled.
Children ages 3 to < 8 years with myopic anisometropic amblyopia will be enrolled into an intermittent occlusion therapy glasses (AmblyzTM) group.
According to visual acuity, they will receive one of two IO-therapy glasses treatment regimens: 1) If the amblyopic eye is between 20/40 to 20/80 inclusive, 4-hour IO-therapy glasses or 2) If the amblyopic eye is between 20/100 to 20/400 inclusive, the child will receive12-hour IO-therapy glasses.
- Conditions
- Amblyopia
- Being tested
- IO-therapy Glasses, patch
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IO-therapy GlassesDevice
12-hour of 50% intermittent occlusion therapy on the fellow eye.
patchDevice
6-hour of eye patch on the fellow eye
| Study group | Role | What they receive |
|---|---|---|
| 12-hour IO-therapy Glasses | Experimental | wear IO-therapy glasses for 12-hour Receives: Device: IO-therapy Glasses |
| 6-hour patching | Active comparator | wear the eye patch for 6-hour Receives: Device: patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Improvement
Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
Measured: 12± 1 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start19 Dec 2016
- Primary completion30 May 2021
- Study completion30 May 2021
Why it stopped: Enrollment is challenging and study materials were not produced any more.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Principal investigator, Jingyun Wang, Salus University
- Investigators
- Jingyun Wang, PhD, Principal investigator, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687581
- Sponsor's protocol ID
- HJW1602
- Status last verified
- Nov 2022
- First submitted
- 16 Feb 2016
- Last updated
- 22 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia
- ClinicalTrials.gov ID
- NCT02687581
- Acronym / sponsor ID
- HJW1602
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment is challenging and study materials were not produced any more.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Posted 22 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the effectiveness of a novel amblyopia treatment - Intermittent occlusion therapy (IO-therapy) glasses (AmblyzTM) in treating severe amblyopia.
Children ages 3 to 8 years with severe amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.
The study also observe the effectiveness of IO-therapy glasses on two types of difficult amblyopia: deprivation amblyopia associated with congenital or developmental cataract, and myopic anisometropic amblyopia.
Detailed description
Children ages 3 to < 8 years with severe/dense amblyopia (visual acuity of 20/100 to 20/400 in the amblyopic eye) will be enrolled and randomized into two groups: 1) standard 6-hour patching group or 2) 12-hour IO-therapy glasses group.
Children ages 3 to < 8 years with deprivation amblyopia associated with congenital or developmental cataracts (visual acuity of 20/40 to 20/400 in the amblyopic eye) will be enrolled.
Children ages 3 to < 8 years with myopic anisometropic amblyopia will be enrolled into an intermittent occlusion therapy glasses (AmblyzTM) group.
According to visual acuity, they will receive one of two IO-therapy glasses treatment regimens: 1) If the amblyopic eye is between 20/40 to 20/80 inclusive, 4-hour IO-therapy glasses or 2) If the amblyopic eye is between 20/100 to 20/400 inclusive, the child will receive12-hour IO-therapy glasses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-hour IO-therapy Glasses | Experimental | Device: IO-therapy Glasseswear IO-therapy glasses for 12-hour |
| 6-hour patching | Active comparator | Device: patchwear the eye patch for 6-hour |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Age 3 to < 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
- Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
Key exclusion criteria (18 listed)
- • Amblyopic eye has myopia worse than -3.00D spherical equivalent.
- If patients are in the deprivation amblyopia category, the following criteria must be met for the patient to be enrolled in the study:
- Age 3 to < 8 years
- Amblyopia due to previous congenital or developmental cataract surgery.
- Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
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 |
|---|---|---|
| IO-therapy Glasses12-hour of 50% intermittent occlusion therapy on the fellow eye. | Device | 12-hour IO-therapy Glasses |
| patch6-hour of eye patch on the fellow eye | Device | 6-hour patching |
Primary outcome
Visual Acuity Improvement
Time frame: 12± 1 weeks after treatment
Visual acuity was measured with ATS-HOTV methods in logMAR. The larger amount means the worse acuity. Visual acuity improvement is defined as the change at the primary outcome follow-up visit from the baseline. (Note: Visual acuity improvement = Visual acuity at the baseline - Visual acuity at the 12-week follow-up) The larger amount of change indicates better improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
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.
Jingyun Wang, PhD principal investigator
Salus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IO-therapy Glasses and patch in people with Amblyopia, run by Salus University 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 14 inclusion and 18 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 22 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 22 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Acuity Improvement (time frame: 12± 1 weeks after treatment). 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 2022.