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Recruiting NCT03655912

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

No phase Interventional Amblyopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Red/green glasses, Electronic Tablet, Eye patch.
Who it may be relevant to
Registry conditions: Amblyopia. Basic parameters: 4 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and/or movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.

Detailed description

The objective of this study is to determine if the binocular visual therapy with red-green glasses and the use of electronic devices is effective for amblyopia treatment in children.

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.

Interventions

  • Device Red/green glasses
    The use of red/green glasses and electronic devices for two hours a day during 4 months.
  • Device Electronic Tablet
    The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.
  • Device Eye patch
    The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.

Primary outcome measures

  • Best corrected visual acuity of the amblyopic eye [Time frame: Basal]
  • Best corrected visual acuity of the amblyopic eye [Time frame: One month of treatment]
  • Best corrected visual acuity of the amblyopic eye [Time frame: Two months of treatment]
  • Best corrected visual acuity of the amblyopic eye [Time frame: Three months of treatment]
  • Best corrected visual acuity of the amblyopic eye [Time frame: Four months of treatment]
  • Best corrected visual acuity of the amblyopic eye two months after treatment suspension to determine lazy eye relapses [Time frame: Two months after treatment suspension.]
Secondary outcome measures (6)
  • Stereopsis [Time frame: Basal]
  • Stereopsis [Time frame: One month of treatment]
  • Stereopsis [Time frame: Two months of treatment]
  • Stereopsis [Time frame: Three months of treatment]
  • Stereopsis [Time frame: Four months of treatment]
  • Stereopsis two months after treatment suspension to determine lazy eye relapses [Time frame: Two months after treatment suspension.]

Eligibility criteria

Inclusion criteria

  • Patients with anisometropic amblyopia, strabismic amblyopia or both
  • 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 other amblyopia diagnosis (deprivation)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey

Publications

  • 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. PMID 26263202
  • 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. PMID 27832248
  • Hunter D. Amblyopia: The clinician's view. Vis Neurosci. 2018 Jan;35:E011. doi: 10.1017/S0952523817000189. No abstract available. PMID 29905115
  • 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. PMID 18513466
  • 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. PMID 17325157
  • Grant S, Moseley MJ. Amblyopia and real-world visuomotor tasks. Strabismus. 2011 Sep;19(3):119-28. doi: 10.3109/09273972.2011.600423. PMID 21870915
  • 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. PMID 16540485
  • 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. PMID 21540479

Identifiers

NCT: NCT03655912 · OF17-00013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗