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Evaluating the myopia progression control efficacy of defocus-incorporated multiple segments (DIMS) lenses and Apollo progressive-addition spectacle lenses (PAL) in 6-12 years old children: a prospective, multi-center, randomized controlled trial

Multi-center clinical comparative study for the effectiveness of functional spectacle lenses in the treatment of myopia in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025645
Enrollment
Unknown
Registered
2019-09-03
Start date
2019-10-31
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

Myopia

Interventions

DIMS group:DIMS spectacle lenses
APL group:APL spectacle lenses

Sponsors

Eye Diseases and Optometry Institute, Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: The following eligibility criteria exist for this trial: Mainland Chinese, the Han nationality. Age at enrolment: 6–12 years old. Cycloplegic spherical equivalent refraction (SER): -1.00 to -4.00 diopters (D). SER is calculated as the sphere plus 0.5 x the cylinder, in diopters (D). (Recommended dosage for cycloplegic refraction is 2 drops of 1% tropicamide given 5 minutes separately. Cycloplegic refraction outcome measures should be performed 30-45 minutes after the first drop of tropicamide is instilled, which ensure the maximal cycloplegic effect.) Astigmatism:1.50 D or less. Anisometropia: 1.50 D or less. The difference of pupil between eyes of 2 mm or less. Monocular best corrected visual acuity (BCVA): 20/20 (0.0 logMAR) or better (LogMar chart). Willingness to wear spectacle lenses regularly. Acceptance of random group allocation and the masked study design.

Exclusion criteria

Exclusion criteria: Strabismus: checked by cover test at far and near. Any ocular and systemic diseases, including abnormalities might affect visual functions or refractive development. Previous experience of myopia control, including orthokeratology, progressive addition lenses, bifocal lenses, pharmaceutical treatment (e.g. atropine), etc.

Design outcomes

Secondary

MeasureTime frame
Axial length;Non-cycloplegic autorefraction;Peripheral refraction;Best-corrected VA (BCVA;Habitual spectacle VA;Accommodation lag;Accommodation amplitude;Slit-lamp exam, external ocular health check;IOP measurement;Pupil size;Keratometry;Contrast sensitivity;Stereopsis;Choroidal thickness measurement;Fundus exam;Visual habits;Parental myopia status;—

Primary

MeasureTime frame
Cycloplegic subjective refraction;—

Countries

China

Contacts

Public ContactYan Li

Eye Diseases and Optometry Institute, Peking University People's Hospital

41379226@qq.com+86 13522998100

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026