AmblyopiaNCT01973348
Comparison of AmblyzTM Glasses and Patching for Amblyopia
A study testing 4-hour AmblyZ glasses, 12-hour AmblyZ glasses and 2-hour patching in people with Amblyopia, run by Indiana University at 1 site in United States.
Trial summary
Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- 4-hour AmblyZ glasses, 12-hour AmblyZ glasses and 2-hour patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2016
- 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
- Both genders and all races are eligible to this study.
- Age 3 to 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
- Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference >3 logarithm of the minimum angle of resolution (logMAR) lines
- Wearing of optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
Who cannot join
- No amblyopia treatment before enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.
Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment.
Read more
The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment.
This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia.
Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group.
Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.
- Conditions
- Amblyopia
- Being tested
- 4-hour AmblyZ glasses, 12-hour AmblyZ glasses, 2-hour patching, 6-hour patching
- 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.
4-hour AmblyZ glassesDevice
4-hour AmblyZ glasses for moderate amblyopia
12-hour AmblyZ glassesDevice
12-hour AmblyZ glasses for severe amblyopia
2-hour patchingDevice
2-hour patching for moderate amblyopia
6-hour patchingDevice
6-hour patching for severe amblyopia
| Study group | Role | What they receive |
|---|---|---|
| 4-hour AmblyZ glasses | Experimental | 4-hour AmblyZ glasses for moderate amblyopia Receives: Device: 4-hour AmblyZ glasses |
| 2-hour eye patching | Active comparator | 2-hour eye patching for moderate amblyopia Receives: Device: 2-hour patching |
| 12-hour AmblyZ glasses | Experimental | 12-hour AmblyZ glasses for severe amblyopia Receives: Device: 12-hour AmblyZ glasses |
| 6-hour eye patching | Active comparator | 6-hour eye patching for severe amblyopia Receives: Device: 6-hour patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Change During 12 Weeks
Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: funding and personnel are lack.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973348
- Sponsor's protocol ID
- 1307011930
- Status last verified
- Jul 2017
- First submitted
- 25 Oct 2013
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wang J, Neely DE, Galli J, Schliesser J, Graves A, Damarjian TG, Kovarik J, Bowsher J, Smith HA, Donaldson D, Haider KM, Roberts GJ, Sprunger DT, Plager DA. A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia. J AAPOS. 2016 Aug;20(4):326-31. doi: 10.1016/j.jaapos.2016.05.014. Epub 2016 Jul 12.
PubMed 27418249
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AmblyzTM Glasses and Patching for Amblyopia
- ClinicalTrials.gov ID
- NCT01973348
- Acronym / sponsor ID
- 1307011930
- Conditions
- Amblyopia
- Keywords
- amblyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding and personnel are lack.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.
Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment.
The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment.
This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia.
Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group.
Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4-hour AmblyZ glasses | Experimental | Device: 4-hour AmblyZ glasses4-hour AmblyZ glasses for moderate amblyopia |
| 2-hour eye patching | Active comparator | Device: 2-hour patching2-hour eye patching for moderate amblyopia |
| 12-hour AmblyZ glasses | Experimental | Device: 12-hour AmblyZ glasses12-hour AmblyZ glasses for severe amblyopia |
| 6-hour eye patching | Active comparator | Device: 6-hour patching6-hour eye patching for severe amblyopia |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Both genders and all races are eligible to this study.
- Age 3 to 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
- Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference >3 logarithm of the minimum angle of resolution (logMAR) lines
Key exclusion criteria (1 listed)
- No amblyopia treatment before enrollment.
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 |
|---|---|---|
| 4-hour AmblyZ glasses4-hour AmblyZ glasses for moderate amblyopia | Device | 4-hour AmblyZ glasses |
| 12-hour AmblyZ glasses12-hour AmblyZ glasses for severe amblyopia | Device | 12-hour AmblyZ glasses |
| 2-hour patching2-hour patching for moderate amblyopia | Device | 2-hour eye patching |
| 6-hour patching6-hour patching for severe amblyopia | Device | 6-hour eye patching |
Primary outcome
Visual Acuity Change During 12 Weeks
Time frame: 12 weeks
Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27418249Wang J, Neely DE, Galli J, Schliesser J, Graves A, Damarjian TG, Kovarik J, Bowsher J, Smith HA, Donaldson D, Haider KM, Roberts GJ, Sprunger DT, Plager DA. A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia. J AAPOS. 2016 Aug;20(4):326-31. doi: 10.1016/j.jaapos.2016.05.014. Epub 2016 Jul 12.
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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 study testing 4-hour AmblyZ glasses, 12-hour AmblyZ glasses and 2-hour patching in people with Amblyopia, run by Indiana 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 6 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: stopped early, as of the sponsor's last update on 25 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2017). 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 Change During 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973348, which also lists 1 linked publication.
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 25 Aug 2017.