High Myopia Clinical Trial
Official title:
Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults: A Randomized, Controlled, Multicenter Clinical Trial
The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 and 40 years, regardless of gender. 2. Presence of myopic refractive error in at least one eye, with myopic lens power after mydriasis exceeding 6.00D, diffusivity less than 2.00D, binocular anisometropia less than 3.00D, and best corrected distance visual acuity of at least 0.6, as well as near visual acuity of at least 0.6. 3. Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment. 4. Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes. 5. Written informed consent obtained from the patients. Exclusion Criteria: 1. History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries. 2. Corneal curvature examination revealing an average K value of the anterior corneal surface of =45. 3. Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia. 4. Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis. 5. Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases. 6. Neurological diseases, allergies, or contraindications to atropine or other therapeutic drugs. 7. Presence of immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, or diabetes. 8. Epilepsy or mental disorders that hinder normal communication. 9. Previous use of other treatments to control myopia progression, such as anticholinergic drugs like atropine within the past 3 months, or participation in other studies involving functional frame lenses, multifocal soft lenses, or similar interventions. 10. Any other situation deemed unsuitable for participation in the study by the researcher. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Eye Disease Prevention & Treatment Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Eye Disease Prevention and Treatment Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in axial length of the left and right eyes | The axis of the eye was assessed utilizing the IOL Master (version 5.02, Carl Zeiss, Jena, Germany), which employed simulated eye calibration prior to measurements. To ensure accuracy, three consecutive measurements were taken, and the average value was obtained. If the difference between any two measurements exceeded 0.05mm, a re-measurement was performed. | baseline, 30days, 90 days, 180 days | |
Secondary | Changes of equivalent spherical mirror after mydriatic optometry | Based on previous experience, this instrument requires a treatment duration of 180 days to demonstrate its preventive and control effects. Therefore, the 180-day data changes will be utilized as the evaluation indicator. | baseline, 180 days |
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