High Myopia Nearsightedness, High myopia, Children,
Conditions
Interventions
Red light treatment is performed for 12 months using the research device Eyerising Myopia Management Device. Red light therapy is phototherapy using low power red light at 650 nm. Subjects will be tre
Phototherapies, Myopia prevention theraphy, Children
Sponsors
Ohno Kyoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of consent Age 8 years or older and less than or equal to 18 years old or younger at enrollment. High myopia cycloplegic sphere less than or equal to -6.00 dioptres in both eyes. Willing and able to participate in all required activities of the study. Normal Fundus , tessellated fundus or with peripapillary diffuse chorioretinal atrophy
Exclusion criteria
Exclusion criteria: The children undergoing or previously treated with myopia control treatments, eg orthokeratology, low dose atropine eye drops, multifocal soft contact lenses. However, children currently using only low dose atropine eye drops, can be recruited but atropine treatment should be discontinued for at least 2 weeks. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome. Pathologic myopia with signs of macula involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs spots. Strabismus and binocular vision abnormalities in either eye. Previous Any intraocular surgery affecting refractive status. Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of AL shortening greater than 0.05mm at 12-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence rates of AL reduction greater than 0.10 mm and 0.20 mm at 12 months follow up. (2) Incidence rate of AL shortening greater than 0.05mm at 1, 3, and 6 month follow-up visits. (3) The time when AL was shortened most in 12 months in patients with AL shortening. (4) Magnitude of AL shortening at 12month follow up among shortened eyes. (5) Changes of choriocapillaris flow deficit, choroidal vascularity index, choroidal thickness assessed by ultrawide-field/widefield OCT scan at 1, 3, 6 and 12month follow-up visits compared with those at baseline. (6) Best corrected visual acuity, OCT structural changes on neurosensory layer, RPE and choroidal layer, self reported AE. (7) Changes in AL and other biometric parameters at 1, 3, 6 and 12 month follow-up visits (8) Change of cycloplegic SER at 1, 3, 6 and 12 month follow up visits (9) Change of META PM grading at 1, 3, 6 and 12 month follow up visits (10) Report of adverse events by questionnaire and interview examination at the time of visit. | — |
Contacts
Public ContactTae Igarashi
Institute of Science Tokyo Hospital
Outcome results
None listed