Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program
- Conditions
- Amblyopia
- Interventions
- Device: Patching
- Registration Number
- NCT06150391
- Lead Sponsor
- Hospital de Merida
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- Subjects with nystagmus, ocular pathology o cognitive delay will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group GA-C. Patients without previous occlusion o penalization treatment - Control 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 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 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.
- Primary Outcome Measures
Name Time Method BCVA Best Corrected Visual Acuity Treatment will last 12 weeks, with BCVA measurements every 2 weeks. The stability control post treatment will last 12 months, with BCVA controls at 3, 6 and 12 months. Best Corrected Visual Acuity is the measurement of the ability to distinguish shapes and the details of objects at a given distance wearing full refraction. Different optotipes are used to measure clinically this ability (e.g. Snellen E, ETDRS, etc.). Refraction must be calculated under cyclopegia following PEDIG criteria. Crowding bars can be added to the optotypes.
In this study, amblyopic eye BCVA will be measured using visual acuity chart ETDRS whitout crowding bars, in logarithmic scale.
- Secondary Outcome Measures
Name Time Method Stereoacuity Treatment will last 12 weeks, with stereoacuity measurements every 2 weeks. The stability control post treatment will last 12 months, with stereoacuity controls at 3, 6 and 12 months. In this stuty Randot Preschool Stereoacuity Test (Stereo Optical, Inc., Chicago, USA) will be used to asses stereoacuity in arc seconds. This is a random dot stereogram that measures global stereopsis (or cyclopean stereopsis) and does not contain monocular cues. Stereoacuity is measured at a constant distance of 40 cm.
Trial Locations
- Locations (1)
Servicio de Oftalmología del Hospital de Merida
🇪🇸Mérida, Extremadura, Spain