Status:
TERMINATED
NEIVATECH Virtual Reality-based System for Amblyopia
Lead Sponsor:
Increase-Tech
Collaborating Sponsors:
University of Alicante
University of Valladolid
Conditions:
Amblyopia
Eligibility:
All Genders
7-15 years
Phase:
NA
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 perce...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04819386
Start Date
July 1 2022
End Date
September 30 2024
Last Update
October 4 2024
Active Locations (2)
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1
University Clinical Hospital of Valladolid
Valladolid, Valladolid, Spain, 47003
2
Vithas Medimar International Hospital
Alicante, Spain, 3016