Clinical trial NCT04819386: NEIVATECH Virtual Reality-based System for Amblyopia
Official title: Prospective Pilot Study of the NEIVATECH Virtual Reality-based System to Improve Visual Function in Children with Amblyopia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amblyopia
Keywords: Amblyopic children
Perceptual learning
Dichoptic training
Virtual reality
Gamification
Lead sponsor: Increase-Tech
Sponsor class: OTHER
Collaborators: name: University of Alicante
name: University of Valladolid
name: Hospital Clínico Universitario de Valladolid
First posted: 2021-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in distance best-corrected visual acuity (BCVA)
timeFrame: Baseline - 1 month
Secondary outcomes:
measure: Change in near BCVA
timeFrame: Baseline - 1 month
measure: Change in photopic contrast sensitivity function (CSF)
timeFrame: Baseline - 1 month
Other outcomes:
measure: Change in refraction under cycloplegia
timeFrame: Baseline - 1 month
measure: Change in stereopsis
timeFrame: Baseline - 1 month
measure: Change in binocular vision
timeFrame: Baseline - 1 month
measure: Change in fusional vergence
timeFrame: Baseline - 1 month
measure: Change in accommodative facility
timeFrame: Baseline - 1 month
measure: Change in near point of convergence
timeFrame: Baseline - 1 month
Locations:
city: Alicante
country: Spain
facility: Vithas Medimar International Hospital
city: Valladolid
country: Spain
facility: University Clinical Hospital of Valladolid
Study officials:
affiliation: University of Valladolid
name: Juan Francisco Arenillas Lara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leal Vega L, Pinero DP, Hernandez Rodriguez CJ, Molina Martin A, Morales-Quezada L, Vallelado Alvarez AI, Arenillas Lara JF, Coco Martin MB. Study protocol for a randomized controlled trial of the NEIVATECH virtual reality system to improve visual function in children with anisometropic amblyopia. BMC Ophthalmol. 2022 Jun 7;22(1):253. doi: 10.1186/s12886-022-02466-z.