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A randomized controlled study of multifocal spectacles for preclinical myopia in children

A randomized controlled study of multifocal spectacles for preclinical myopia in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063586
Enrollment
Unknown
Registered
2022-09-12
Start date
2022-09-12
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

myopia

Interventions

Stellest? lens:Stellest? lens
Optical lens:Optical lens

Sponsors

Eye & ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Subjects must be 6-9 years old (less than 10 years old) at the time of initial screening. ? Subjects and their parents/legal guardians must: - Read the informed consent - fully informed and explained of the consent form - indicates understanding of the consent form - Signed informed consent Work with parents/legal guardians to understand the nature of the study and be willing to comply with the requirements of the study Agree with your parents/legal guardian to follow the schedule of the study Agree to wear the assigned glasses for at least 5 days per week, with an average of at least 4 hours per day. During the study period, if the wearing schedule needs to be interrupted, please inform the ophthalmologist and the investigator in charge of the study. If the interruption is due to health reasons, the ophthalmologist in charge of the study will adjust the wearing time according to the situation Maintain good physical health Subjects have UDVA of 0.10 logMAR (0.8) or better for both eyes Post-dilated diopter (computerized optometry) at the time of initial screening must meet the following criteria: - Equivalent sphere range +1.50 to 0.00D(inclusive) - Astigmatism = -0.75 D - Binocular anisometropia = 0.75 D

Exclusion criteria

Exclusion criteria: The subject is currently enrolled in another clinical trial or was enrolled in another clinical trial within 30 days prior to enrollment Has used or is currently using any form of myopia control methods Patients with comorbid eye disorders, suspicion of keratoconus and presence of comorbid systemic diseases

Design outcomes

Primary

MeasureTime frame
Axial length;Spherical equivalent;Choroidal thickness;

Secondary

MeasureTime frame
Incidence of myopia;uncorrected visual acuity(UCVA);

Countries

China

Contacts

Public ContactZhi Chen

Eye & ENT Hospital, Fudan University

peter459@aliyun.com13761681740

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026