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Effectiveness of Virtual Reality Training in Amblyopia

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Zhejiang University

Status

Enrolling

Conditions

Amblyopia

Treatments

Other: occlusion therapy
Device: visual function training software
Other: corrective glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT05732467
2022-0755

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

4 to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

experimental group
Experimental group
Treatment:
Device: visual function training software
Other: corrective glasses
control group
Other group
Treatment:
Other: occlusion therapy
Other: corrective glasses

Trial contacts and locations

1

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Central trial contact

Xiajing Tang

Data sourced from clinicaltrials.gov

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