Clinical trial NCT05732467: Effectiveness of Virtual Reality Training in Amblyopia
Official title: Effectiveness of Virtual Reality Training in Amblyopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia
Keywords: amblyopia
virtual reality
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of visual function training software (model: SJ-JRS2021) in the treatment of mild to moderate amblyopia in children. The main questions it aims to answer are:

* Whether virtual reality training is more effective than occlusion therapy
* Safety of virtual reality training in amblyopia treatment If participants have refractive problems, correct the refraction first and wear corrective glasses. The experimental group will be treated using visual function training therapy software (model: SJ-JRS2021). The control group will be treated with occlusion therapy covering the contralateral eye for 2 hours a day. Researchers will compare experimental group with control group to see if the experimental group has better corrected vision recovery.


Eligibility criteria: Inclusion Criteria:

* Age 4-7 years old (including 4 and 7 years old), both sexes;
* Monocular amblyopia was diagnosed;
* The corrected visual acuity of amblyopia is between 0.2 (inclusive) and 0.6, and the binocular visual difference is more than 2 lines;
* The guardian of the subject can understand the purpose of the trial and sign the informed consent. The subject can cooperate with the treatment and related ophthalmic examination

Exclusion Criteria:

* The subject has tumor, heart disease, hypertension and epilepsy;
* The subject has an implanted electronic device, such as a pacemaker;
* The subject has suffered from mental illness;
* Subject suffers from vertigo, fear of heights or brain trauma;
* The subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time;
* The subject has strabismus or congenital cataract, congenital ptosis, trauma and other ocular organic lesions and related surgical history;
* Subject has had any form of treatment for amblyopia other than refractive correction and covering treatment.
* Other conditions, such as severe heart, liver and kidney disease, under which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient.

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 16 weeks
Secondary outcomes:
measure: Near stereopsis
timeFrame: 16 weeks
measure: contrast sensitivity
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiajing Tang
role: STUDY_CHAIR
References: