Randomized Controlled Trial of a Dichoptic Gabor Videogame Program to Improve Visual Function in Children With Amblyopia
| Registry | NCT06150391 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 125 (Actual) |
| Sponsor | Hospital de Merida (Other); collaborators: VisionaryTool, S.L. |
| Conditions | Amblyopia |
| Interventions | Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks, Patching (Device) |
| Dates | start 2023-12-04, primary completion 2026-10-15, completion 2026-10-15, first posted 2023-11-29, last updated 2026-10-20 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Amblyopia All trials of Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks All trials of Patching
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.
Amblyopia is a common neurodevelopmental abnormality that results in physiological alterations of the visual pathways and impaired vision in one eye or, less commonly, in both.Disruption of normal visual development early in life may result in perceptual, oculomotor and clinical abnormalities such as instability of fixation, anomalous retinal correspondence, and lack of stereoacuity.Amblyopia has a prevalence of around 2-4% in children and is associated with refractive error (anisometropia or isometropia) and strabismus.
The Pediatric Eye Disease Investigator Group (PEDIG) has produced several studies that analyze the most effective therapies for amblyopic eye. The gold standard treatment prescribed for this condition combines spectacle correction of the refractive error with penalization and/or occlusion of the dominant eye
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.
This randomized clinical trial is designed to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer activity that uses dichoptic Gabor Patches and band-filtered noise masks. It combines the concepts of perceptual learning, dichoptic training, home based therapy and gamification.
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 as coadjuvant to pathching solve amblyopia in patients where 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 if this novel approach may lead to greater improvements in vision performance in amblyopic children as substitution of occlusion treatment in novel amblyopia or as coadjutant in persistent amblyopia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group GA-E. Patients without previous occlusion o penalization treatment - Experimental | Experimental | Device: Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks | GA-E volunteers (experimental) will be prescribed home therapy using computer-based exercises (Visionary) for 12 weeks, five days week, ½ half hour per day. Visionary target frequencies will be adjusted, considering BCVA, each three weeks. Contrast of Gabor patch frequencies will be adjusted to match patient contrast sensitivity thresholds. In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will change to GA-C. |
| Group GA-C. Patients without previous occlusion o penalization treatment - Control | Active comparator | Device: Patching | GA-C patients (control) will be prescribed occlusion following Pediatric Eye Disease Investigation Group (PEDIG) criteria: 2 hours for mild and moderate amblyopia or 6 hours for severe amblyopia. Patients will receive a calendar to track patching accomplishment. In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will change to GA-E. |
| Group GB-E. Patients with previous occlusion o penalization treatment - Experimental | Experimental | Device: Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks; Device: Patching | GB-E volunteers will receive occlusion following PEDIG criteria and will be prescribed home therapy using Visionary. Patients will receive a calendar to track patching accomplishment. Visionary target frequencies will be adjusted, considering BCVA, each three weeks. |
| Group GB-C. Patients with previous occlusion o penalization treatment - Control | Active comparator | Device: Visionary: computer exercises using dichoptic Gabor Patches and band-filtered noise masks; Device: Patching | GB-C volunteers will receive occlusion following PEDIG criteria and will be prescribed home therapy using Visionary. Patients will receive a calendar to track patching accomplishment. Visionary target frequencies will always be low, no matter patient VA. In case BCVA does not improve at least 2 lines in two consecutive visits (6 weeks), patients will be move to GB-E. |
Sex: All, ages: 4 Years to 12 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Servicio de Oftalmología del Hospital de Merida | Mérida, Extremadura | Spain |