NEIVATECH Virtual Reality-based System for Amblyopia

Not Applicable

Terminated

• Conditions: Amblyopia
• Interventions: Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system

• Registration Number: NCT04819386
• Lead Sponsor: Increase-Tech

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.

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Study Start: 2022-07-01
• Status Verified: 2023-09
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-30
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active group	Active vision therapy sessions with the NEIVATECH Virtual Reality-based system	18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system

Primary Outcome Measures

Name	Time	Method
Change in distance best-corrected visual acuity (BCVA)	Baseline - 1 month	ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Vithas Medimar International Hospital; 🇪🇸 Alicante, Spain

University Clinical Hospital of Valladolid; 🇪🇸 Valladolid, Spain