Amblyopia
Conditions
Keywords
Amblyopic children, Perceptual learning, Dichoptic training, Virtual reality, Gamification
Brief summary
The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task.
Detailed description
Due to the global impact of amblyopia, there is a medical and social need, and at the same time, a clear market niche, for the design and development of new therapies that can improve recurrence rates and non-compliance with conventional treatments. In this sense, the aim of this single-arm, multicentre, prospective pilot study is to examine the safety, acceptability and clinical efficacy of a novel Virtual Reality-based system designed to provide binocular vision training to 7-15 year old amblyopic children complementing the concepts of perceptual learning and dichoptic training with a gamification approach.
Interventions
OTHERActive vision therapy sessions with the NEIVATECH Virtual Reality-based system
The active visual therapy sessions with the NEIVATECH Virtual Reality-based system will be 18 in total, will have an average duration of half an hour and will be distributed over a month as follows: 5 sessions in the first two weeks after enrollment (Monday to Friday) and 4 sessions in the next two weeks (Monday to Thursday).
Sponsors
University of Alicante
University of Valladolid
Hospital Clínico Universitario de Valladolid
Increase-Tech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children aged between 7 and 15 years. * VA in the amblyopic eye \< 0.1 logMAR units. * Interocular difference in VA ≥ 1 logMAR line. * Interocular difference in espherical equivalent ≥ 1 D. * Interpupillary distance (IPD) between 60.7 and 73.5 mm. * Use of best refractive correction for at least 2 months prior to inclusion. * Lack of response or therapeutic adherence to conventional occlusion therapy. * Willingness to attend all the active vision therapy sessions and/or visits of the study. * No history of previous treatment for amblyopia other than optimal refractive correction for at least 2 months prior to inclusion.
Exclusion criteria
* Active eye disease. * Previous ocular surgery. * BCVA in the amblyopic eye of ≥ 0.70 logMAR. * Presence of cognitive impairment or neurological or psychiatric disorders. * Presence of irregular cornea due to astigmatism or ectatic corneal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in distance best-corrected visual acuity (BCVA) | Baseline - 1 month | ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in near BCVA | Baseline - 1 month | ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse) |
| Change in photopic contrast sensitivity function (CSF) | Baseline - 1 month | CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in fusional vergence | Baseline - 1 month | Magnitude of base-out and base-in prisms needed to obtain diplopia while the patient is looking at a distance and near (40 cm) stimulus |
| Change in refraction under cycloplegia | Baseline - 1 month | Magnitude of sphere and cylinder (diopters), orientation of axis of astigmatism (degrees) |
| Change in near point of convergence | Baseline - 1 month | Closest distance in cm in reference to the nasal root of the patient at which the subject is able to maintain single vision |
| Change in accommodative facility | Baseline - 1 month | Number of changes performed achieving an optimum focus using a spherical flipper of +-2.00 D while the patient is looking at a near optotype (VA 0,63) |
| Change in stereopsis | Baseline - 1 month | Magnitude of stereoacuity (seconds of arc) |
| Change in binocular vision | Baseline - 1 month | Worth's four dot test and Four prism dioptre reflex text |
Countries
Spain
Outcome results
None listed