Status:
COMPLETED
The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial
Lead Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Collaborating Sponsors:
Zuoguan Medical Equipment Co., Ltd. at Suzhou Industrial Park
Children's Hospital of Soochow University
Conditions:
Age 3 to 16 Years (Inclusive), Male or Female
Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief Summary
Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents. Methods: Subject population: Children aged 3-16 y...
Detailed Description
Design: The trial was a randomized, controlled, multicenter clinical trial. A total of 190 children aged 3-16 years with high myopia were selected and divided into 95 cases in the test group and 95 ca...
Eligibility Criteria
Inclusion
- age 3 to 16 years (inclusive), male or female
- clinical diagnosis confirming that myopia has occurred in at least one eye.
- the guardian voluntarily signed the "Subject's Informed Consent Form"
Exclusion
- history of photosensitivity, glaucoma, glaucoma syndrome, high intraocular pressure, macular lesion or injury in the fundus ② corneal curvature examination, the average K value of the anterior surface of the cornea ≥ 45; ③ combined with heart, liver, kidney and other systemic diseases and prior.
- Combination of cardiac, hepatic, renal, and other systemic diseases and congenital myopia; ④ Combination of ocular trauma and congenital myopia.
- ④ Combined with ocular trauma and chronic ocular diseases such as apparently oblique or operated eyes, atopic keratoconjunctivitis, etc.; ⑤ Previous presence of entropion.
- ⑤ Those with previous entropion and other eye diseases such as severe corneal and conjunctival infections; ⑥ Those with combined neurological diseases and other eye diseases.
- (6) Those with combined neurological disorders and allergies or contraindications to atropine drugs or other therapeutic drugs; (7) Albinism and psoriasis.
- (7) Patients with albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes mellitus, and other immune system and systemic diseases; (8) Epilepsy, psychiatric disorders.
- ⑧ epilepsy, mental disorders who cannot communicate normally.
- Previously treated with other treatments to control the development of myopia such as anticholinergic drugs such as atropine within 3 months, or involved in other functional
- Previously treated with other treatments to control the development of myopia, such as anticholinergic drugs like atropine within 3 months, or involved in other studies related to functional frame lenses, multifocal soft lenses, etc.
- Other conditions judged by the investigator to be unsuitable for participation in the study
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2023
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05184621
Start Date
February 4 2021
End Date
April 15 2023
Last Update
November 18 2023
Active Locations (1)
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1
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, China, 200040