NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032220339

Registered date:20/09/2022

Red-light therapy for highly myopic children

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedHigh Myopia
Date of first enrollment18/10/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)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 treated with a therapy device twice a day from Monday to Friday, three minutes per session, with a minimum interval of 4 hours, under the supervision of their parents.

Outcome(s)

Primary OutcomeIncidence rate of AL shortening greater than 0.05mm at 12-month follow-up.
Secondary Outcome(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.

Key inclusion & exclusion criteria

Age minimum>= 8age old
Age maximum<= 18age 11month 4weeks old
GenderBoth
Include criteriaProvision 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
Exclude criteriaThe 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.

Related Information

Contact

Public contact
Name Tae Igarashi
Address 1-5-45 Yushima Bunkyo-ku TOKYO Tokyo Japan 113-8519
Telephone +81-3-5803-5681
E-mail yokooph@tmd.ac.jp
Affiliation Tokyo Medical and Dental University Hospital
Scientific contact
Name Kyoko Ohno
Address 1-5-45 Yushima Bunkyo-ku TOKYO Tokyo Japan 113-8519
Telephone +81-3-5803-5681
E-mail k.ohno.oph@tmd.ac.jp
Affiliation Tokyo Medical and Dental University Hospital