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Study on the effectiveness and safety of Dichoptic Training for amblyopia

Research on VR therapy for amblyopia

12

In the 10 cases (excluding withdraw cases), the average age at consent acquisition was 7.9 years, with 7 males and 3 females. All cases had a history of amblyopia treatment. Nine cases underwent occlusion therapy, and 2 cases underwent topical eye drop therapy.

Treatment was administered to all 12 cases for which consent was obtained. Of these, treatment was discontinued in 2 cases. The reasons for discontinuation were 'withdrawal of consent or refusal to participate in the study by the research subject or their authorized representative' and 'determination of ineligibility after enrollment in this study,' each occurring in one case.

Two cases of nasopharyngitis, one case of upper respiratory tract inflammation, and one case of hypersensitivity were observed. All were mild, resolved, and were determined to have no causal relationship with the study.

[Primary endpoint] The mean logMAR visual acuity (standard deviation) was 0.4558 (0.1122) at baseline, and 0.3655 (0.1298) after 16 weeks of treatment. The mean change (95% confidence interval) was -0.0903 (-0.19078 to 0.01016), and the mean change rate (95% confidence interval) was -17.5 (-39.8 to 4.8)%. No statistically significant changes were observed for either measure. [Secondary Endpoints] (1) Measurements, Change Amounts, and Change Rates of Best Corrected Visual Acuity in the Amblyopic Eye at Each Time Point The mean change amounts in best corrected visual acuity (logMAR visual acuity) in the amblyopic eye at 4 weeks, 8 weeks, and 12 weeks after treatment were 0.0079, -0.0366, and -0.0301, respectively. The mean change rates were 1.7%, -6.6%, and -4.4%, respectively. No statistically significant changes were observed at any time point. (2) Improvement Rate, Stable Rate, and Deterioration Rate of Best Corrected Visual Acuity in Amblyopic Eyes After 16 weeks of treatment, 3 cases (30.0%) showed improvement, 7 cases (70.0%) remained stable, and 0 cases deteriorated. (3) Measurements, change amounts, and change rates of stereoscopic disparity The mean change amounts in stereoscopic disparity at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after treatment were -0.048, -0.135, -0.058, and -0.199, respectively. The mean change rates were 0%, -2.3%, 0.8%, and -4.3%, respectively. No statistically significant changes were observed at any time point. (4) Measurements, Change Amounts, and Change Rates of Best Corrected Visual Acuity in the Healthy Eye The mean change in best-corrected visual acuity (logMAR) in the healthy eye at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after treatment initiation was -0.0115, -0.0108, -0.0291, and -0.0194, respectively. The mean change rate was 14.5%, 13.6%, 36.7%, and 24.5%, respectively. No statistically significant changes were observed at any time point. (5) Questionnaire on subjective symptoms related to eyes and whole body associated with VR use The mean (standard deviation) of the total score for the questionnaire on subjective symptoms related to eyes and whole body associated with VR use was 12.7 (2.0), and after 16 weeks of implementation, it was 13.5 (4.6). The mean (standard deviation) of the change amount was 0.8 (4.4). No statistically significant changes were observed. (6) Measurements, Change Amounts, and Change Rates of Uncorrected Visual Acuity in Amblyopic and Normal Eyes The mean change in uncorrected visual acuity (logMAR acuity) in the amblyopic eye at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after treatment was 0.0675, 0.0185, -0.0044, and -0.0472, respectively. The mean change rate was 9.3%, 2.0%, 2.0%, and -4.7%, respectively. The mean change in uncorrected visual acuity (logMAR visual acuity) in the healthy eye at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after treatment was 0.0088, -0.0020, -0.0115, and -0.0069, respectively. The mean change rate was -12.5%, 2.8%, 16.1%, and 9.7%, respectively.

This study demonstrated the safety and practicality of VR-based dioptric training for anisometropic amblyopia. Regarding therapeutic efficacy, while trends toward improved visual acuity and stereopsis were observed, no statistically significant differences were found. Nevertheless, the presence of cases showing improvement in either visual acuity or stereopsis indicates that VR-based dichoptic training holds promise as an adjunctive treatment for cases unresponsive to conventional amblyopia therapy.

Oct. 24, 2025

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs052230073

Morimoto Takeshi

The University of Osaka Hospital

2-15 Yamadaoka, Suita, Osaka

takeshi.morimoto@ophthal.med.osaka-u.ac.jp

Morimoto Takeshi

The University of Osaka Hospital

2-15 Yamadaoka, Suita, Osaka

+81-6-6879-3456

takeshi.morimoto@ophthal.med.osaka-u.ac.jp

Complete

July. 20, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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 whose visual acuity does not improve sufficiently after 4 months or more of spectacle correction.
(6) Individuals who are able to properly use the test equipment with HMD.
(7) 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.

(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 constant strabismus.
(5) Individuals with developmental disabilities.
(6) Individuals who have undergone ophthalmic surgery within the past year.
(7) Individuals with hearing impairments.
(8) Individuals with inter-pupillary distance less than 5.0 cm or exceeding 7.7 cm.
(9) Individuals who are currently participating or will participate in other intervention studies
(10) Individuals who have a head injury, vertigo, vestibular, balance disorder, headache, or who are at risk for photosensitive seizures.
(11) Others, individuals deemed unsuitable as research subjects by the principal investigator or co-investigator.

Both

Anisometropic amblyopia

Dichoptic training for 20-30 minutes once a day, 5 times a week for 16 weeks.

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.

(1) Measurement values and rate of change in best-corrected visual acuity for amblyopic eyes before and at 4, 8, and 12 weeks after the implementation of dichoptic training.
(2) Change in best corrected visual acuity of amblyopic eye before and 4, 8, 12, and 16 weeks after implementation of dichoptic training.
(3) Change in best corrected visual acuity of amblyopic eye (improved, unchanged, or worse) before and after 4, 8, 12, and 16 weeks of dichoptic training.
(4) Measurement values of stereopsis before and at 4, 8, 12, and 16 weeks after the implementation of dichoptic training.
(5) Measurement values of best-corrected visual acuity for the fellow healthy eye before and at 4, 8, 12, and 16 weeks after the implementation of dichoptic training.
(6) Adherence to dichoptic training until 4, 8, 12, and 16 weeks after implementation.
(7) Questionnaire regarding self-reported ocular and systemic symptoms associated with the use of virtual reality (VR) before, at 4 weeks, and 16 weeks after the implementation of dichoptic training.

+81-6-6210-8296

July. 11, 2023

none