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Recruiting NCT03655912

NCT03655912 Binocular Visual Therapy and Video Games for Amblyopia Treatment.

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Clinical Trial Summary
NCT ID NCT03655912
Status Recruiting
Phase
Sponsor Universidad Autonoma de Nuevo Leon
Condition Amblyopia
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2018-10-09
Primary Completion 2026-10

Eligibility & Interventions

Sex All sexes
Min Age 4 Years
Max Age 10 Years
Study Type INTERVENTIONAL
Interventions
Red/green glassesElectronic TabletEye patch

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2018-10-09 with a primary completion date of 2026-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Marissa L. Fernandez-de Luna, MD

✉ dra.fernandezdeluna@gmail.com

📞 +528183469259

Principal Investigator

Marissa L. Fernandez-de Luna, MD

PRINCIPAL INVESTIGATOR

Universidad Autonoma de Nuevo Leon

Frequently Asked Questions

Who can join the NCT03655912 clinical trial?

This trial is open to participants of all sexes, aged 4 Years or older, up to 10 Years, studying Amblyopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03655912 currently recruiting?

Yes, NCT03655912 is actively recruiting participants. Contact the research team at dra.fernandezdeluna@gmail.com for enrollment information.

Where is the NCT03655912 trial being conducted?

This trial is being conducted at Monterrey, Mexico.

Who is sponsoring the NCT03655912 clinical trial?

NCT03655912 is sponsored by Universidad Autonoma de Nuevo Leon. The principal investigator is Marissa L. Fernandez-de Luna, MD at Universidad Autonoma de Nuevo Leon. The trial plans to enroll 60 participants.

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