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NEIVATECH Virtual Reality-based System for Amblyopia (NEIVATECH)

Primary Purpose

Amblyopia

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Active vision therapy sessions with the NEIVATECH Virtual Reality-based system

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Amblyopic children, Perceptual learning, Dichoptic training, Virtual reality, Gamification

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children aged between 5 and 17 years.
Willingness to perform the assigned therapy and to carry out the established visits.
No history of previous treatment for amblyopia other than optimal refractive correction for at least 2 months prior to inclusion in the study.
BCVA in the amblyopic eye of ≤ 0.1 logMAR with at least 1 logMAR line difference between the two eyes of the same patient.
Presence of anisometropia defined as a difference in spherical equivalent between the two eyes of ≥ 1.5 dioptres.

Exclusion Criteria:

Active eye disease.
Previous ocular surgery.
BCVA in the amblyopic eye of ≥ 0.70 logMAR.
Presence of strabismic or deprivation amblyopia.
Presence of microtropia or intermittent strabismus.
Presence of irregular cornea due to astigmatism or ectatic corneal disease.
Presence of cognitive impairment or psychiatric or neurological disorders.

Sites / Locations

Vithas Medimar International HospitalRecruiting
University Clinical Hospital of ValladolidRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active group

Arm Description

18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system

Outcomes

Primary Outcome Measures

Change in distance best-corrected visual acuity (BCVA)

ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Secondary Outcome Measures

Change in near BCVA

ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Change in photopic contrast sensitivity function (CSF)

CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree

Full Information

NCT ID

NCT04819386

First Posted

March 18, 2021

Last Updated

September 26, 2023

Sponsor

Increase-Tech

Collaborators

University of Alicante, University of Valladolid, Hospital Clínico Universitario de Valladolid

1. Study Identification

Unique Protocol Identification Number

NCT04819386

Brief Title

NEIVATECH Virtual Reality-based System for Amblyopia

Acronym

NEIVATECH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Increase-Tech

Collaborators

University of Alicante, University of Valladolid, Hospital Clínico Universitario de Valladolid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amblyopia

Keywords

Amblyopic children, Perceptual learning, Dichoptic training, Virtual reality, Gamification

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active group

Arm Type

Experimental

Arm Description

18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system

Intervention Type

Other

Intervention Name(s)

Active vision therapy sessions with the NEIVATECH Virtual Reality-based system

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in distance best-corrected visual acuity (BCVA)

Description

ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Time Frame

Baseline - 1 month

Secondary Outcome Measure Information:

Title

Change in near BCVA

Description

ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)

Time Frame

Baseline - 1 month

Title

Change in photopic contrast sensitivity function (CSF)

Description

CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree

Time Frame

Baseline - 1 month

Other Pre-specified Outcome Measures:

Title

Change in refraction under cycloplegia

Description

Magnitude of sphere and cylinder (diopters), orientation of axis of astigmatism (degrees)

Time Frame

Baseline - 1 month

Title

Change in stereopsis

Description

Magnitude of stereoacuity (seconds of arc)

Time Frame

Baseline - 1 month

Title

Change in binocular vision

Description

Worth's four dot test and Four prism dioptre reflex text

Time Frame

Baseline - 1 month

Title

Change in fusional vergence

Description

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

Time Frame

Baseline - 1 month

Title

Change in accommodative facility

Description

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)

Time Frame

Baseline - 1 month

Title

Change in near point of convergence

Description

Closest distance in cm in reference to the nasal root of the patient at which the subject is able to maintain single vision

Time Frame

Baseline - 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Francisco Arenillas Lara, PhD

Phone

+34637890926

Ext

+34

juanfarenillas@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

María Begoña Coco Martín, PhD

Phone

607802586

Ext

+34

mbegococom@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Francisco Arenillas Lara, PhD

Organizational Affiliation

University of Valladolid

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vithas Medimar International Hospital

City

Alicante

ZIP/Postal Code

3016

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Piñero Llorens, PhD

david.pinyero@gcloud.ua.es

Facility Name

University Clinical Hospital of Valladolid

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

María Begoña Coco Martín, PhD

mbegococom@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35672688

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.

Results Reference

derived

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NEIVATECH Virtual Reality-based System for Amblyopia

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