NEIVATECH Virtual Reality-based System for Amblyopia (NEIVATECH)

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

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.

Study Overview

• Status: Terminated
• Conditions: Amblyopia
• Intervention / Treatment: Other: Active vision therapy sessions with the NEIVATECH Virtual Reality-based system

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 3016
    • Vithas Medimar International Hospital
  • Valladolid, Spain, 47003
    • University Clinical Hospital of Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Active group; 18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in near BCVA	ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)	Baseline - 1 month
Change in photopic contrast sensitivity function (CSF)	CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree	Baseline - 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in refraction under cycloplegia	Magnitude of sphere and cylinder (diopters), orientation of axis of astigmatism (degrees)	Baseline - 1 month
Change in stereopsis	Magnitude of stereoacuity (seconds of arc)	Baseline - 1 month
Change in binocular vision	Worth's four dot test and Four prism dioptre reflex text	Baseline - 1 month
Change in fusional vergence	Magnitude of base-out and base-in prisms needed to obtain diplopia while the patient is looking at a distance and near (40 cm) stimulus	Baseline - 1 month
Change in accommodative facility	Number of changes performed achieving an optimum focus using a spherical flipper of +-2.00 D while the patient is looking at a near optotype (VA 0,63)	Baseline - 1 month
Change in near point of convergence	Closest distance in cm in reference to the nasal root of the patient at which the subject is able to maintain single vision	Baseline - 1 month

Collaborators and Investigators

• Sponsor: Increase-Tech
• Collaborators: University of Valladolid; University of Alicante; Hospital Clínico Universitario de Valladolid
• Investigators: Principal Investigator: Juan Francisco Arenillas Lara, PhD, University of Valladolid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Virtual reality; Gamification; Amblyopic children; Perceptual learning; Dichoptic training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia
• Other Study ID Numbers: CASVE-NM-21-516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No