Myopia in school children
Conditions
Interventions
For 6 months, wearing only eyeglasses that emit violet light
For 6 months, wearing only pseudo-placebo-eyeglasses that emit violet light
Sponsors
Tsubota Laboratory, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female Japanese school children from 6 to 12 years of age (elementary school from 1st to 6th grade) at the time of obtaining informed consent. (2) School children whose cycloplegic objective refraction (spherical equivalent) for each eye is between -1.50 D and -4.50 D. (3) School children with anisometropia within 1.50 D. (4) School children with astigmatism within plus/minus 1.50 D for each eye. (5) School children with corrected visual acuity equal or exceeding 1.0 for each eye. (6) School children who can use cycloplegia. (7) School children who can attend the clinic for consultations in accordance with the protocol. (8) School children and their legally acceptable representative who can provide written informed consent. (9) School children with at least one parent who is myopia.
Exclusion criteria
Exclusion criteria: (1) School children who have received ophthalmic operation, including refractive surgeries previously. (2) School children who take psoralen. (3) School children who have previous history of photosensitivity or its suspect. (4) School children who have previous history of epilepsy. (5) School children with binocular visual function impairment. (6) School children with amblyopia or manifest strabismus. (7) School children who have a 1.50D or larger difference between bilateral eyes in both cycloplegic and non-cycloplegic objective refractions (spherical equivalent). (8) School children who have previous or current history of myopia treatment. (9) School children who have previous history of allergy against test drugs that are used in this study. (10) School children who cannot wear eyeglasses continuingly that are used in this study. (11) School children whose family member (brother, sister or etc.) living together participates in this study. (12) School children who are judged to be inappropriate as subjects for this study by the principle investigator (or investigators) for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation by comparison of results of visual acuity, intraocular pressure, eye position, tear break up time (BUT), and corneal endothelial cell density, etc from screening up to 6 months for each visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in axial lengths and cycloplegic objective refractions (spherical equivalent) from screening up to 6 months for each visit. | — |
Countries
Japan
Contacts
Public ContactShinichiro Kondo
Tsubota Laboratory, Inc. Research & Development Division
Outcome results
None listed