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

Amblyopia Clinical Trial

— OPTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080285
• Other study ID #: 1404-021-017
• Status: Completed
• Phase: N/A
• First received: March 9, 2017
• Last updated: March 14, 2017
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• over-glasses patch
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 patch
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

References & Publications (3)

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. — View 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 o — View 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 amblyop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	17 weeks
Secondary	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.	17 weeks
Secondary	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.	17 weeks
Secondary	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).	17 weeks