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AmblyopiaOPTANCT03080285

Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study

A study testing over-glasses patch and Conventional patch in people with Amblyopia, run by Pusan National University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes. Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Amblyopia
What is being tested?
over-glasses patch and Conventional patch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
No sites listed yet
Study dates
Jul 2014to May 2016
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 3 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • moderate amblyopia (logMAR visual acuity in the amblyopic eye 0.3 to 0.7 inclusive)
  • logMAR visual acuity in the sound eye of 0.1 or better
  • intereye acuity difference of larger or equal to 0.3 of logMAR visual acuity
  • the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia.

Who cannot join

  • presence of an ocular cause for low vision
  • myopia greater than -6.0 diopters (D) spherical equivalent in either eye
  • prior intraocular or refractive surgery
  • treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment
  • Down syndrome

About this study

Official title: Efficacy of Over-glasses Patch Treatment for Amblyopia in Children :OPTA Study, A Prospective Randomized Clinical Trial

This is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.

Read the detailed description

In a randomized multi-center controlled clinical trial, children younger than 7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to receive treatment with either a conventional patch or an over-glasses patch. The patients will be prescribed 2 hours of patching per day for the sound eye. Best-corrected visual acuity (BCVA) and stereopsis will be investigated and ATI questionnaires be collected from parents at 5 weeks and 17 weeks after the initiation of treatment.

Conditions
Amblyopia
Being tested
over-glasses patch, Conventional patch
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • over-glasses patchDevice

    Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.

  • Conventional patchDevice

    Conventional patch (Opticlude Eye Patch, 3M, Maplewood, MN, USA) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.

Study groups in NCT03080285
Study groupRoleWhat they receive
Conventional patchActive comparatorThe patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time. Conventional patch is occlusion treatment sticker (Opticlude Eye Patch, 3M, Maplewood, MN, USA) with an adhesive material attached to the skin and serves to cover the eyes.
Receives: Device: Conventional patch
over-glasses patchExperimentalthe patients were prescribed 2 hours of patching per day for the sound eye and the spectacles were to be worn full-time. Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is made of fabric and covers the glasses, hence serves to cover the eyes.
Receives: Device: over-glasses patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in visual acuity (logMAR)

    changes in best- corrected visual acuity between before treatment and after 17 weeks.

    Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.

    Measured: 17 weeks

Secondary outcomes (3)

  1. amblyopia treatment index

    A modified version of ATI was provided to the parent(s) of all the enrolled minor patients as part of their follow-up visit with their child. The test consisted of 20 items, translated to Korean by one English language specialist and three ophthalmologists. The score from each question contributed to a sub-scale of the adverse effect (question numbers 2, 3, 4, 7, 8, 9, 13, and 16), compliance (question numbers 1, 5, 6a, 10 and 12), and social stigma (question numbers 11, 14 and 18). The questionnaires were scored on a 5-point Likert scale system, and the parent-provided questionnaire used a strength of agreement scale with responses of "strongly agree" (5), "agree" (4), "neither agree nor disagree" (3), "disagree" (2), "strongly disagree" (1), and "not applicable." In the test, the majority of items were negative statements, and therefore, a higher score indicated a higher negative impact or a higher burden. Reverse scoring was applied to the few items that were positive statements.

    Measured: 17 weeks

  2. the best corrected visual acuity

    best corrected visual acuity (logMAR) at 17 weeks Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.

    Measured: 17 weeks

  3. change of binocularity

    A binocularity index was determined with the use of the Worth 4 Dot test at near and the Titmus stereo test with a scale ranging from 0 to 4 with the following characteristics: 0, indicating complete suppression; 1, a moderate central suppression scotoma with peripheral fusion at near only indicated by fusion on the Worth 4 Dot test at near; 2, a small suppression scotoma and peripheral fusion indicated by fusion of the Titmus stereo fly; 3, moderate stereoacuity (100-400 arc seconds) on the stereo test animals (1 to 3 animals) and/or on the stereo test circles (1 to 5 circles); and 4, good stereoacuity (<80 arc seconds ) on the stereo test circles (6 to 9 circles).

    Measured: 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study startJul 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080285
Sponsor's protocol ID
1404-021-017
Acronym
OPTA
Status last verified
Mar 2017
First submitted
9 Mar 2017
Last updated
15 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Scheiman MM, Hertle RW, Beck RW, Edwards AR, Birch E, Cotter SA, Crouch ER Jr, Cruz OA, Davitt BV, Donahue S, Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh DW, Tamkins SM; Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol. 2005 Apr;123(4):437-47. doi: 10.1001/archopht.123.4.437.

    PubMed 15824215

  • Flynn JT, Schiffman J, Feuer W, Corona A. The therapy of amblyopia: an analysis of the results of amblyopia therapy utilizing the pooled data of published studies. Trans Am Ophthalmol Soc. 1998;96:431-50; discussion 450-3.

    PubMed 10360300

  • Wallace MP, Stewart CE, Moseley MJ, Stephens DA, Fielder AR; Monitored Occlusion Treatment Amblyopia Study (MOTAS) Cooperatives; Randomized Occlusion Treatment Amblyopia Study (ROTAS) Cooperatives. Compliance with occlusion therapy for childhood amblyopia. Invest Ophthalmol Vis Sci. 2013 Sep 17;54(9):6158-66. doi: 10.1167/iovs.13-11861.

    PubMed 23882695

Questions about this trial

What is this clinical trial studying?

A study testing over-glasses patch and Conventional patch in people with Amblyopia, run by Pusan National University Hospital.

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 4 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: finished, as of the sponsor's last update on 15 Mar 2017. 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?

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?

Changes in visual acuity (logMAR) (time frame: 17 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 NCT03080285, which also lists 3 linked publications.

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 15 Mar 2017.

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