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Binocular Visual Therapy and Video Games for Amblyopia Treatment.

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Oct 2025 to Oct 2026
    • Study completion date: Dec 2025 to Dec 2026
    v9
  2. Notable Primary completion date: Oct 2023 to Oct 2025
    • Study completion date: Dec 2023 to Dec 2025
    v8
  3. Notable Primary completion date: Oct 2022 to Oct 2023
    • Study completion date: Dec 2022 to Dec 2023
    v7
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Notable Primary completion date: Oct 2020 to Oct 2022
    • Study completion date: Dec 2020 to Dec 2022
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Sep 2018 to Oct 2020
    • Study completion date: Dec 2018 to Dec 2020
    • Start date changed from estimate of Sep 2018 to Oct 9, 2018
    • Site details revised
  3. Notable Primary endpoints revised (6)
    • Eligibility criteria revised
    • Secondary endpoints revised (6)
    • Study description revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03655912
Lead Sponsor Universidad Autonoma de Nuevo Leon
Collaborators: Hospital Universitario Dr. Jose E. Gonzalez
Conditions
(from sponsor)
Amblyopia
Related terms Amblyopia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov