Binocular Visual Therapy and Video Games for Amblyopia Treatment.

NCT03655912 | Recruiting

• 1 other identifier: OF17-00013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amblyopia

Keywords

Amblyopia; Binocular therapy; Videogames

Outcome Measures

Primary Outcomes (6)

• Best corrected visual acuity of the amblyopic eye

  Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

  Basal

• Best corrected visual acuity of the amblyopic eye

  Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

  One month of treatment

• Best corrected visual acuity of the amblyopic eye

  Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

  Two months of treatment

• Best corrected visual acuity of the amblyopic eye

  Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

  Three months of treatment

• Best corrected visual acuity of the amblyopic eye

  Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

  Four months of treatment

• Best corrected visual acuity of the amblyopic eye two months after treatment suspension to determine lazy eye relapses

  Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

  Two months after treatment suspension.

Secondary Outcomes (6)

• Stereopsis

  Basal

• Stereopsis

  One month of treatment

• Stereopsis

  Two months of treatment

• Stereopsis

  Three months of treatment

• Stereopsis

  Four months of treatment

Study Arms (3)

Patch

ACTIVE COMPARATOR

Eye patch on the fellow eye and to near-vision activities (such as reading, drawing, etc)

Device: Eye patch

Electronic Devices

EXPERIMENTAL

Eye patch on the fellow eye and a electronic tablet

Device: Electronic Tablet

Red/Green Glasses

EXPERIMENTAL

Red/green glasses and a electronic tablet

Device: Red/green glasses

Interventions

Red/green glasses DEVICE

The use of red/green glasses and electronic devices for two hours a day during 4 months.

Red/Green Glasses

Electronic Tablet DEVICE

The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.

Electronic Devices

Eye patch DEVICE

The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.

Patch

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Hospital Universitario Dr. Jose E. Gonzalez: collaborator

Study Sites (1)

Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• Hunter D. Amblyopia: The clinician's view. Vis Neurosci. 2018 Jan;35:E011. doi: 10.1017/S0952523817000189. No abstract available.

  PMID: 29905115 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19933184 BACKGROUND

• 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.

  PMID: 16520328 BACKGROUND

• 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.

  PMID: 18235004 BACKGROUND

• 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.

  PMID: 27756405 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marissa L. Fernandez-de Luna, MD

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa L. Fernandez-de Luna, MD

CONTACT

+528183469259; dra.fernandezdeluna@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the patient or the care provider will be aware of the treatment modality group the patient is in. In order to achieve that, patients in different modality groups will be evaluated in different days preventing information of group modality gossip between the patients parents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: October 9, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

ME (1)