NIPH Clinical Trials Search

Axial Length and Refractive Changes in Children with Myopia Control Lens

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Myopia
Date of first enrollment	28/04/2026
Target sample size	44
Countries of recruitment
Study type	Interventional
Intervention(s)	Use of Study Device: Full-time wear is required. Eye Drops for Cycloplegic Examination: Tropicamide/phenylephrine hydrochloride ophthalmic solution and cyclopentolate hydrochloride ophthalmic solution are to be instilled 1 drop twice in each eye (bilaterally)

Outcome(s)

Primary Outcome	Change in axial length from baseline at 12 months
Secondary Outcome	Change in cycloplegic SRE from baseline at 12 months Changes in objective and subjective refraction status and visual acuity Wavefront aberration at baseline Prescription power of the spectacles Questionnaire on myopia and spectacle wear Ocular biometric measurements Presence or absence of spectacle defects Change in choroidal thickness

Key inclusion & exclusion criteria

Age minimum	>= 6age old
Age maximum	<= 15age old
Gender	Both
Include criteria	Age between 6 and 15 years old Spherical equivalent refraction between -8.0 and -1.0 D in both eyes under cycloplegic objective refraction Astigmatism of 2.0 D or less Anisometropia of 1.5 D or less
Exclude criteria	Patients who have ocular diseases other than refractive error that may affect visual acuity or refractive status, Patients who have any eye with best-corrected visual acuity (BCVA) less than 1.0 History of intraocular or refractive surgery Patients in whom cycloplegic examination is difficult to perform due to drug allergies or other reasons Patients deemed inappropriate for inclusion in this study by the principal investigator or sub-investigator Patients with prior experience of any of the following myopia progression control treatments within the specified periods listed below: 0.01% atropine eye drops: within the past 1 month 0.025% atropine eye drops: within the past 3 months Multifocal soft contact lenses (SCL): within the past 1 month Patients with prior experience of myopia progression control treatments other than those listed above