NEIVATECH Virtual Reality-based System for Amblyopia

Increase-Tech

Status: Terminated

Conditions: Amblyopia

Treatments: Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system

Study type: Interventional

Funder types: Other

Identifiers

NCT04819386

CASVE-NM-21-516

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Active group

Experimental group

Description:

18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system

Treatment:

Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system