NCT04819386

NEIVATECH Virtual Reality-based System for Amblyopia

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Increase-Tech · Academic / Other
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
OTHER	Active 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).

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-07-01
• Completion: 2024-09-30
• First posted: 2021-03-29
• Last updated: 2024-10-04

Locations

2 sites across 1 country: Spain