NEIVATECH Virtual Reality-based System for Amblyopia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Pilot Study of the NEIVATECH Virtual Reality-based System to Improve Visual Function in Children With Amblyopia

Conditions
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Amblyopia

Intervention / Treatment
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* Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system | Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distance best-corrected visual acuity (BCVA) | ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse) | Baseline - 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in near BCVA | ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse) | Baseline - 1 month | 
| Change in photopic contrast sensitivity function (CSF) | CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree | Baseline - 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amblyopic children, Perceptual learning, Dichoptic training, Virtual reality, Gamification