Research on VR therapy for amblyopia

JRCT ID: jRCTs052230073

Registered date:20/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anisometropic amblyopia
• Date of first enrollment: 06/09/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Dichoptic training for 20-30 minutes once a day, 5 times a week for 16 weeks.

Outcome(s)

• Primary Outcome: 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.

Secondary Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: <= 15age old
• Gender: Both

Include 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 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.

Exclude 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 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.

Related Information

• Primary Sponsor: Morimoto Takeshi