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Completed
NCT06150391
Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program
Conditions: Amblyopia
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 125
Sponsor: Hospital de Merida
Location: Servicio de Oftalmología del Hospital de Merida Mérida Extremadura
Summary
Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Moreover, occlusion is associated with a high risk of recurrence and non-compliance. Here, it is presented a protocol of a randomized clinical trial to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer game.
The goal of this prospective clinical trial is to compare in visual acuity improvements in patients with amblyopia, following conventional patching therapy or this novel computer-based therapy.
The main questions it aims to answer are:
* Does computer-based therapy equal or improve patching therapy? Can it be used as an alternative to patching?
* Does computer-based therapy used in combination with pathching solve amblyopia when patching fails alone (persistent amblyopia)?
Participants will be divided in two groups according to the previous occlusion o penalization of fellow eye. Both groups will be divided in two subgroups, experimental and control. Researchers will compare subgroups outcomes in order to asses this novel approach.
Eligibility Criteria
Inclusion Criteria:
* The sample will be made up of children with amblyopia from 4 to 12 years old (amblyopia will be defined as the best corrected visual acuity less o equal to 0.8 in decimal units or \> 2 lines of difference between both eyes). Strabismus inclusion criteria will be \< 25 prismatic diopters, with a deviation ≥ 2 prismatic diopters.
Exclusion Criteria:
* Subjects with nystagmus, ocular pathology o cognitive delay will be excluded.
Source: ClinicalTrials.gov (NCT06150391). StuddyBuddy aggregates publicly available trial information.