NIPH Clinical Trials Search

Contact Lens-Based Atropine Therapy for Pediatric Myopia Progression

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	myopia
Date of first enrollment	19/05/2026
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	In this trial, all participants will be prescribed 0.025% atropine eye drops and will be randomly assigned to one of the following two groups: the extended depth-of-focus contact lens group (wearing SEED 1dayPure EDOF) or the single-vision contact lens group (wearing SEED 1dayPure UP).

Outcome(s)

Primary Outcome	Change in axial length at 12 months
Secondary Outcome	Change in spherical equivalent refractive error (under cycloplegia) Change in axial length at 6 months Contact lens wearing comfort

Key inclusion & exclusion criteria

Age minimum	>= 6age old
Age maximum	<= 12age old
Gender	Both
Include criteria	1) Participants must be diagnosed with pediatric myopia, based on cycloplegic refraction using spherical equivalent (SE). 2) Participants must be aged between 6 and 12 years at the time of enrollment and must be elementary school students. 3) The spherical equivalent refractive error in both eyes under cycloplegic refraction must be less than or equal to -1.00 D and greater than or equal to -6.00 D. 4) The cylindrical refractive error (astigmatism) in both eyes under cycloplegic refraction must be less than or equal to 1.00 D. 5) Anisometropia, defined as the interocular difference in spherical equivalent refractive error under cycloplegic refraction, must be less than 1.50 D. 6) Best-corrected visual acuity (BCVA) with correction based on spherical equivalent refractive error must be 1.0 or better in both eyes.
Exclude criteria	1) Participants with a history of treatment for myopia control are excluded. 2) Participants with corneal diseases, including corneal degeneration, corneal scarring, or keratoconus, are excluded. 3) Participants with severe allergic conjunctivitis are excluded. 4) Participants with abnormal binocular visual function, including amblyopia or strabismus, are excluded. 5) Participants with a known drug allergy to atropine are excluded.