NEIVATECH Virtual Reality-based System for Amblyopia

Amblyopia Clinical Trial

— NEIVATECH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819386
• Other study ID #: CASVE-NM-21-516
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Increase-Tech
• Contact: Juan Francisco Arenillas Lara, PhD
• Phone: +34637890926
• Email: juanfarenillas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia

Intervention

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).

Locations

Country	Name	City	State
Spain	Vithas Medimar International Hospital	Alicante
Spain	University Clinical Hospital of Valladolid	Valladolid

Sponsors (4)

Lead Sponsor	Collaborator
Increase-Tech	Hospital Clínico Universitario de Valladolid, University of Alicante, University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in refraction under cycloplegia	Magnitude of sphere and cylinder (diopters), orientation of axis of astigmatism (degrees)	Baseline - 1 month
Other	Change in stereopsis	Magnitude of stereoacuity (seconds of arc)	Baseline - 1 month
Other	Change in binocular vision	Worth's four dot test and Four prism dioptre reflex text	Baseline - 1 month
Other	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
Other	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
Other	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
Primary	Change in distance best-corrected visual acuity (BCVA)	ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)	Baseline - 1 month
Secondary	Change in near BCVA	ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)	Baseline - 1 month
Secondary	Change in photopic contrast sensitivity function (CSF)	CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree	Baseline - 1 month