Contact Lens-Based Atropine Therapy for Pediatric Myopia Progression

Contact Lens-Based Atropine Therapy for Pediatric Myopia Progression A Controlled Comparative Study Using Single-Vision Contact Lenses - Contact Lens-Based Atropine Therapy for Pediatric Myopia Progression A Controlled Comparative Study Using Single-Vision Contact Lenses (The CLAMP Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052260042

Enrollment

Registered

2026-05-19

Start date

2026-05-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia Childhood myopia

Interventions

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 S

D003261

Myopia control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Change in axial length at 12 months	—

Secondary

Measure	Time frame
Change in spherical equivalent refractive error (under cycloplegia) Change in axial length at 6 months Contact lens wearing comfort	—

Contacts

Public ContactOsamu Hieda

University Hospital Kyoto Prefectural University of Medicine

ohieda@koto.kpu-m.ac.jp+81-752515578

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026