An interventional study of Active vision therapy sessions with the NEIVATECH Virtual Reality-based system in Amblyopia, sponsored by Increase-Tech. Terminated at 2 sites in Spain. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Increase-Tech · Not applicable, Interventional, and Treatment
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.
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.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 133 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Increase-Tech is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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).
Change in distance best-corrected visual acuity (BCVA)
ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)
Time frame: Baseline - 1 month
Change in near BCVA
ETDRS, logMAR scale, maximum -0.3 (best) and minimum 1.20 (worse)
Time frame: Baseline - 1 month
Change in photopic contrast sensitivity function (CSF)
CSV-1000 test for spatial frequencies of 3, 6, 12 and 18 cycles/degree
Time frame: Baseline - 1 month
Change in refraction under cycloplegia
Magnitude of sphere and cylinder (diopters), orientation of axis of astigmatism (degrees)
Time frame: Baseline - 1 month
Change in stereopsis
Magnitude of stereoacuity (seconds of arc)
Time frame: Baseline - 1 month
Change in binocular vision
Worth's four dot test and Four prism dioptre reflex text
Time frame: Baseline - 1 month
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
Time frame: Baseline - 1 month
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)
Time frame: Baseline - 1 month
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
Time frame: Baseline - 1 month
Plan to share: No
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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