Effectiveness of Virtual Reality Training in Amblyopia

Amblyopia Clinical Trial

Official title:

Effectiveness of Virtual Reality Training in Amblyopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732467
• Other study ID #: 2022-0755
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiajing Tang
• Phone: +86 13732227517
• Email: xiajingtang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• visual function training software
Experimental group: If there is a refractive problem, first correct the refraction, wear corrective glasses, and then use visual function training therapy software (model: SJ-JRS2021) for treatment.

Other:
• occlusion therapy
Control group: If there is a refractive problem, correct the refraction first, wear corrective glasses combined with occlusion therapy, and cover the fellow eye for 2 hours a day.
• corrective glasses
corrective glasses

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity		16 weeks
Secondary	Near stereopsis		16 weeks
Secondary	contrast sensitivity		16 weeks