NEIVATECH Virtual Reality-based System for Amblyopia

N/ATerminatedNCT04819386

Increase-Tech20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amblyopia

Interventions

Active vision therapy sessions with the NEIVATECH Virtual Reality-based systemOTHER

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).

Eligibility

Sex: ALLMin age: 7 YearsMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (2)

University Clinical Hospital of Valladolid

Valladolid, Valladolid, Spain

Vithas Medimar International Hospital

Alicante, Spain

Outcomes

Primary Outcomes

Change in distance best-corrected visual acuity (BCVA)

ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Time frame: Baseline - 1 month

Secondary Outcomes

Change in near BCVA

ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Time frame: Baseline - 1 month

Change in photopic contrast sensitivity function (CSF)

CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree

Time frame: Baseline - 1 month

Data from ClinicalTrials.gov

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