Status:
UNKNOWN
the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
Lead Sponsor:
He Eye Hospital
Conditions:
Myopia
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM) development and progression. Atropine eye drop is beneficial in reducing initial NITM and slowing down myopic ...
Detailed Description
Myopia is a common condition that develops primarily during childhood and early adulthood when excessive elongation of the eye results in images of distant objects coming into focus in front of the re...
Eligibility Criteria
Inclusion
- Age 6 to 12 years
- Subjects and their guardians agreed to participate in this study
- Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or better.
- Initial NITM (spherical equivalent) ≤ -0.25 D
- Cycloplegic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes.
- Anisometropia in both eyes ≤ 1.5 D
Exclusion
- Children with existing systemic diseases including asthma, collagen disease, immune system disorders, prostate hypertrophy, spastic paralysis, Down's syndrome, severe cardiac, pulmonary, hepatic, and renal dysfunction.
- Patients with glaucoma or high intraocular pressure, ocular inflammatory diseases, strabismus, amblyopia, corneal diseases, diseases of lens, retinal and optic neuropathy
- Regular use of medications that may affect the efficacy of 0.01% atropine, including hairy fruit rutabaga eye drops, tropicamide eye drops, anticholinergic drugs such as pirenzepine and tropicamide, and cholinergic drugs such as carbachol and hairy fruit rutabaga.
- Previous experiences with myopia control therapy.
- A history of allergies to atropine.
- Patients were deemed inappropriate for trial participation by the lead investigator.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06034366
Start Date
October 1 2023
End Date
May 31 2025
Last Update
November 29 2023
Active Locations (2)
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1
He Eye Hospital
Shenyang, Liaoning, China, 110034
2
He Eye Specialist Hospital
Shenyang, China, 110034