Research on VR therapy for amblyopia

Not Applicable

Recruiting

• Conditions: Anisometropic amblyopia

• Registration Number: JPRN-jRCTs052230073
• Lead Sponsor: Morimoto Takeshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

(1) Age between 5 and 15 at the time of obtaining consent.
(2) Individuals with anisometropic amblyopia.
(3) Individuals whose best corrected visual acuity in the amblyopic eye is 0.1 or more but less than 0.5
(4) Individuals whose best corrected visual acuity in the normal eye is 0.7 or better.
(5) Individuals with strabismus angle within +/-10 PD as measured by APCT.
(6) Individuals whose visual acuity does not improve sufficiently after 4 months or more of spectacle correction.
(7) Individuals who are able to properly use the test equipment with HMD.
(8) Individuals who have received sufficient explanation and have a full understanding, and whose written consent has been obtained from both the patient and their legal representative based on their free will.

Exclusion Criteria

(1) Individuals who have undergone atropine treatment within the past two weeks from the date of obtaining consent.
(2) Individuals with a history of ophthalmic surgeries other than strabismus surgery.
(3) Individuals with ocular conditions that cause amblyopia other than refractive abnormalities or heterophoria.
(4) Individuals with developmental disabilities.
(5) Individuals who have undergone ophthalmic surgery within the past year.
(6) Individuals with hearing impairments.
(7) Individuals with inter-pupillary distance less than 5.3 cm or exceeding 7.3 cm.
(8) Individuals who are currently participating or will participate in other intervention studies
(9) Individuals who have a head injury, vertigo, vestibular, balance disorder, headache, or who are at risk for photosensitive seizures.
(10) Others, individuals deemed unsuitable as research subjects by the principal investigator or co-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement values and rate of change in best-corrected visual acuity for amblyopic eyes before and 16 weeks after the implementation of dichoptic training in the research protocol.