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A multicenter clinical study on the evaluation of the effectiveness of digital defocus-based distant-image screen technology in the prevention and control of myopia in children

A multicenter clinical study on the evaluation of the effectiveness of digital defocus-based distant-image screen in the prevention and control of myopia in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092013
Enrollment
Unknown
Registered
2024-11-07
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Myopia

Interventions

Intervention group:Subjects will be optically corrected with single-vision spectacles, and reading, writing and using electronic devices with the help of distant-image screens during their daily near-
Control group:Subjects will be optically corrected with single-vision spectacles, and maintain the conventional near-eye-use habits when studying and using electronic devices in daily life.

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) >=6 years old and = 5.0 in both eyes; 6) The average daily near-eye use (reading, writing, using electronic devices such as cell phones, tablets, or computer screens) is>=1 hour; 7) Volunteer to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) History of ocular surface and intraocular surgery due to organic ocular pathology; 2) Abnormal intraocular pressure ( 21mmHg, or difference in intraocular pressure between two eyes > 5mmHg); 3) Combination of other eye diseases, such as uveitis and other inflammatory diseases, glaucoma, cataracts, fundopathy, ocular tumors, and any ocular pathology that affects visual function; 4) Patients suffering from systemic diseases resulting in immunocompromise; 5) Those who are unable to undergo regular eye examinations; 6) Have participated or are currently participating in any myopia control clinical research trial within three months; 7) Have used or are now using any myopia control products such as keratoconus, multifocal contact lenses, multipoint defocus design myopia control spectacles, feeder lenses, and low-concentration atropine-based medications within three months; 8) Significant strabismus; 9) Those who are judged by the investigator to be ineligible for enrollment

Design outcomes

Primary

MeasureTime frame
AL elongation;

Secondary

MeasureTime frame
Changes in objective SER under cycloplegia;anterior chamber depth;Crystal thickness;Corneal curvature;Choroidal thickness;Choroidal blood flow;

Countries

China

Contacts

Public ContactJia Qu

Eye Hospital of Wen Medical University

jqu@wz.zj.cn+86 577 8806 8888

Outcome results

None listed

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