Clinical trial NCT03080285: Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study
Official title: Efficacy of Over-glasses Patch Treatment for Amblyopia in Children :OPTA Study, A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 107
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in visual acuity (logMAR)
timeFrame: 17 weeks
Secondary outcomes:
measure: amblyopia treatment index
timeFrame: 17 weeks
measure: the best corrected visual acuity
timeFrame: 17 weeks
measure: change of binocularity
timeFrame: 17 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pusan National University hospotal
name: Hee young Choi, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.