Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2022-07-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active group
18 half-hour in-office active vision therapy sessions with the NEIVATECH Virtual Reality-based system
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
7 Years
15 Years
ALL
No
Sponsors
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University of Alicante
OTHER
University of Valladolid
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
Increase-Tech
OTHER
Responsible Party
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Juan Francisco Arenillas Lara
Principal Investigator
Principal Investigators
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Juan Francisco Arenillas Lara, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Valladolid
Locations
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University Clinical Hospital of Valladolid
Valladolid, Valladolid, Spain
Vithas Medimar International Hospital
Alicante, , Spain
Countries
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References
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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.
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.
Other Identifiers
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CASVE-NM-21-516
Identifier Type: -
Identifier Source: org_study_id
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