Binocular Visual Therapy and Video Games for Amblyopia Treatment.
NCT ID: NCT03655912
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2018-10-09
2025-12-31
Brief Summary
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Detailed Description
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Participants will be randomly assigned to one of three treatment modalities: Group A: eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc) Group B: an eye patch on the fellow eye and a electronic tablet Group C: red/green glasses and a electronic tablet
Treatment will be done buy the three groups daily during 2 consecutive hours, and will be completed for four months. Children will then suspend the therapy for 2 months, and will be reevaluated to determine lazy eye relapses . All groups will be compared to see which patients achieved greater improvement on visual acuity and depth perception.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Patch
Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc)
Eye patch
The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.
Electronic Devices
Eye patch on the fellow eye and a electronic tablet
Electronic Tablet
The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.
Red/Green Glasses
Red/green glasses and a electronic tablet
Red/green glasses
The use of red/green glasses and electronic devices for two hours a day during 4 months.
Interventions
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Red/green glasses
The use of red/green glasses and electronic devices for two hours a day during 4 months.
Electronic Tablet
The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.
Eye patch
The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.
Eligibility Criteria
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Inclusion Criteria
* Patients with out previous amblyopia treatment
* Patient with previous strabismus surgery or use of there best corrected visual acuity glasses for at least 1 month
* Birth at term gestational age
* Without any systemic or ophthalmic comorbidities
* Previous patients parent verbal and fiscal assessment.
Exclusion Criteria
* Any previous amblyopia treatment
* Any previous intraocular surgery
* Any ocular condition
* Any neurologic conditions or psychomotor development alterations
* Patients not able to cooperate for visual acuity or stereopsis evaluation
4 Years
10 Years
ALL
No
Sponsors
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Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Universidad Autonoma de Nuevo Leon
OTHER
Responsible Party
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Karim Mohamed-Noriega
Professor
Principal Investigators
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Marissa L. Fernandez-de Luna, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma de Nuevo Leon
Locations
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Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Tailor V, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Cochrane Database Syst Rev. 2015 Aug 11;2015(8):CD011347. doi: 10.1002/14651858.CD011347.pub2.
Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224.
Hunter D. Amblyopia: The clinician's view. Vis Neurosci. 2018 Jan;35:E011. doi: 10.1017/S0952523817000189. No abstract available.
Carlton J, Karnon J, Czoski-Murray C, Smith KJ, Marr J. The clinical effectiveness and cost-effectiveness of screening programmes for amblyopia and strabismus in children up to the age of 4-5 years: a systematic review and economic evaluation. Health Technol Assess. 2008 Jun;12(25):iii, xi-194. doi: 10.3310/hta12250.
Grant S, Melmoth DR, Morgan MJ, Finlay AL. Prehension deficits in amblyopia. Invest Ophthalmol Vis Sci. 2007 Mar;48(3):1139-48. doi: 10.1167/iovs.06-0976.
Grant S, Moseley MJ. Amblyopia and real-world visuomotor tasks. Strabismus. 2011 Sep;19(3):119-28. doi: 10.3109/09273972.2011.600423.
Hrisos S, Clarke MP, Kelly T, Henderson J, Wright CM. Unilateral visual impairment and neurodevelopmental performance in preschool children. Br J Ophthalmol. 2006 Jul;90(7):836-8. doi: 10.1136/bjo.2006.090910. Epub 2006 Mar 15.
Niechwiej-Szwedo E, Goltz HC, Chandrakumar M, Hirji Z, Wong AM. Effects of anisometropic amblyopia on visuomotor behavior, III: Temporal eye-hand coordination during reaching. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5853-61. doi: 10.1167/iovs.11-7314.
O'Connor AR, Birch EE, Anderson S, Draper H; FSOS Research Group. The functional significance of stereopsis. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):2019-23. doi: 10.1167/iovs.09-4434. Epub 2009 Nov 20.
Rahi JS, Cumberland PM, Peckham CS. Does amblyopia affect educational, health, and social outcomes? Findings from 1958 British birth cohort. BMJ. 2006 Apr 8;332(7545):820-5. doi: 10.1136/bmj.38751.597963.AE. Epub 2006 Mar 6.
Webber AL, Wood JM, Gole GA, Brown B. The effect of amblyopia on fine motor skills in children. Invest Ophthalmol Vis Sci. 2008 Feb;49(2):594-603. doi: 10.1167/iovs.07-0869.
Guo CX, Babu RJ, Black JM, Bobier WR, Lam CS, Dai S, Gao TY, Hess RF, Jenkins M, Jiang Y, Kowal L, Parag V, South J, Staffieri SE, Walker N, Wadham A, Thompson B; BRAVO study team. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial. Trials. 2016 Oct 18;17(1):504. doi: 10.1186/s13063-016-1635-3.
Other Identifiers
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OF17-00013
Identifier Type: -
Identifier Source: org_study_id
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