NCT04819386

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 4, 2024

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

March 18, 2021

Last Update Submit

October 2, 2024

Conditions

Amblyopia

Keywords

Amblyopic childrenPerceptual learningDichoptic trainingVirtual realityGamification

Outcome Measures

Primary Outcomes (1)

  • Change in distance best-corrected visual acuity (BCVA)

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

    Baseline - 1 month

Secondary Outcomes (2)

  • Change in near BCVA

    Baseline - 1 month

  • Change in photopic contrast sensitivity function (CSF)

    Baseline - 1 month

Other Outcomes (6)

  • Change in refraction under cycloplegia

    Baseline - 1 month

  • Change in stereopsis

    Baseline - 1 month

  • Change in binocular vision

    Baseline - 1 month

  • +3 more other outcomes

Study Arms (1)

Active group

EXPERIMENTAL

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

Interventions

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

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).

Active group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Clinical Hospital of Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Vithas Medimar International Hospital

Alicante, 3016, Spain

Location

Related Publications (2)

  • Leal-Vega L, Coco-Martin M feminineB, Molina-Martin A, Cuadrado-Asensio R, Vallelado-Alvarez AI, Sanchez-Tocino H, Mayo-Iscar A, Hernandez-Rodriguez CJ, Arenillas Lara JF, Pinero DP. NEIVATECH pilot study: immersive virtual reality training in older amblyopic children with non-compliance or non-response to patching. Sci Rep. 2024 Nov 14;14(1):28062. doi: 10.1038/s41598-024-79565-y.

    PMID: 39543340DERIVED

  • 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.

    PMID: 35672688DERIVED

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan Francisco Arenillas Lara, PhD

    University of Valladolid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 29, 2021

Study Start

July 1, 2022

Primary Completion

July 1, 2024

Study Completion

September 30, 2024

Last Updated

October 4, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)