Evidence map›Paper›PMID 35672688›Full record

ArticleBMC ophthalmology2022

Study protocol for a randomized controlled trial of the NEIVATECH virtual reality system to improve visual function in children with anisometropic amblyopia.

L Leal Vega, D P Piñero, C J Hernández Rodríguez, A Molina Martín, L Morales-Quezada, A I Vallelado Álvarez, J F Arenillas Lara, M B Coco Martín

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04819386 (Prospective Pilot Study of the NEIVATECH Virtual Reality-based System to Improve Visual Function in Children with Amblyopia), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04819386 naterminatednot on this map

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

TypeinterventionalSponsorIncrease-TechRan2022 to 2024Enrolled20ConditionsAmblyopiaArmsActive vision therapy sessions with the NEIVATECH Virtual Reality-based system
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

L Leal VegaGroup of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, Av. Ramón y Cajal, 7, 47005, Valladolid, Spain.
D P PiñeroGroup of Optics and Visual Perception, Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain.
C J Hernández RodríguezGroup of Optics and Visual Perception, Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain.
A Molina MartínGroup of Optics and Visual Perception, Department of Optics, Pharmacology and Anatomy, University of Alicante, Alicante, Spain.
L Morales-QuezadaDepartment of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA.
A I Vallelado ÁlvarezPediatric Ophthalmology Unit, Department of Ophthalmology, University Clinical Hospital of Valladolid, Valladolid, Spain.
J F Arenillas LaraGroup of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, Av. Ramón y Cajal, 7, 47005, Valladolid, Spain. juanfarenillas@gmail.com.ORCID http://orcid.org/0000-0001-7464-6101
M B Coco MartínGroup of Applied Clinical Neurosciences and Advanced Data Analysis, Department of Medicine, Dermatology and Toxicology, University of Valladolid, Av. Ramón y Cajal, 7, 47005, Valladolid, Spain.
Universidad de Valladolid · ESUniversity of Alicante · ESHarvard University · US

Funding

Centre for Industrial Technological Development IDI20181232
6 · The paper itself

Abstract

backgroundInterest in developing alternative methods for the treatment of amblyopia has long been a topic of interest among clinicians and researchers, as prescribed occlusion and penalization therapies do not always provide an effective response and are associated with a high risk of recurrence and non-compliance. Here, we present the protocol of a small-scale RCT to evaluate the safety and clinical efficacy of a novel VR-based system designed to provide binocular vision training to children with anisometropic amblyopia.

methodsWe aim to recruit a total of 60 children with anisometropic amblyopia aged 5-17 years with no previous treatment for amblyopia other than refractive correction from the pediatric ophthalmology units of the University Clinical Hospital of Valladolid and the Vithas Medimar International Hospital of Alicante. Children who meet the eligibility criteria and consent to participate will be randomly assigned to a three-month intervention group of 18 half-hour in-office therapy sessions with the NEIVATECH system (group A) or to a parallel group receiving 2 hours of conventional patching per day at home for the same period of time (group B). Assessments of visual function will be carried out before the intervention and at 1, 2 and 3 months, with changes in distance BCVA being the primary outcome measure to be considered. Patient safety, compliance, satisfaction and acceptance to treatment will also be assessed after therapy as other valuable outcome measures. In addition, a rsfMRI scan will be performed on a subgroup of 5 patients from each group at the pre-intervention visit and at the post-intervention visit to test the effects of both therapies on neural plasticity in the visual cortex. DISCUSSION: The NEIVATECH system has been conceived as a serious game designed to provide binocular vision training to anisometropic amblyopic children by complementing the concepts of perceptual learning, dichoptic training and gamification in an immersive VR environment. We hope that this novel approach may lead to greater improvements in vision performance than those provided so far by conventional patching in anisometropic amblyopic children.

trial registrationThis protocol was registered with ClinicalTrials.gov ( NCT04819386 ) on 29 March 2021.

Indexed as

AmblyopiaVideo GamesVirtual RealityChildHumansRandomized Controlled Trials as TopicSensory DeprivationTreatment OutcomeVision, BinocularVisual AcuityAnisometropic amblyopiaDichoptic trainingGamificationNeural plasticityPerceptual learningVirtual reality

Identifiers

PMID35672688
PMCPMC9172013
OpenAlexW4281625175

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.