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Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03655912
Enrollment
60
Registered
2018-08-31
Start date
2018-10-09
Completion date
2026-12-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Keywords

Amblyopia, Binocular therapy, Videogames

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.

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

DEVICERed/green glasses

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

DEVICEElectronic Tablet

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

DEVICEEye patch

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

Sponsors

Universidad Autonoma de Nuevo Leon
Lead SponsorOTHER
Hospital Universitario Dr. Jose E. Gonzalez
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Best corrected visual acuity of the amblyopic eyeBasalBest corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.
Best corrected visual acuity of the amblyopic eye two months after treatment suspension to determine lazy eye relapsesTwo months after treatment suspension.Best corrected visual acuity of the amblyopic eye using the Snellen chart. Measurements will be converted to LogMar values for statistical analysis.

Secondary

MeasureTime frameDescription
StereopsisBasalStereopsis measurement by titmus test
Stereopsis two months after treatment suspension to determine lazy eye relapsesTwo months after treatment suspension.Stereopsis measurement by titmus test

Countries

Mexico

Contacts

CONTACTMarissa L. Fernandez-de Luna, MD
dra.fernandezdeluna@gmail.com+528183469259
PRINCIPAL_INVESTIGATORMarissa L. Fernandez-de Luna, MD

Universidad Autonoma de Nuevo Leon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026