Recruitment difficulties

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.

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.