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Evaluation of the safety and efficacy of the D.D.C dual-control technology framework glasses lenses in delaying the progression of myopia: a randomized controlled trial

Evaluation of the safety and efficacy of the D.D.C dual-control technology framework glasses lenses in delaying the progression of myopia: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111459
Enrollment
Unknown
Registered
2025-10-31
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Myopic

Interventions

test group:D.D.C dual-control technology framework glasses lenses
control group:HOYA Aspheric Mono-Optic Resin Lenses

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. 8 years old = -1.50 D, and the absolute value of the difference between the equivalent spherical lenses of both eyes(refractive error)= 1.0 in both eyes; 4. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. A history of ocular trauma or intraocular surgery; 2. clinically abnormal slit lamp examination findings; 3. funduscopic findings >= grade 2; 4. Abnormal intraocular pressure (IOP 21 mmHg); 5. Combined with other eye diseases, such as uveitis and other kinds of inflammation, glaucoma, cataract, fundus disease, ocular tumors, ocular trauma, patients with dominant strabismus; as well as any ocular pathology that affects visual function; 6. Patients suffering from systemic diseases resulting in immunocompromise (e.g. diabetes mellitus, Down's Syndrome, rheumatoid arthritis, psychiatric patients, or any other diseases considered by the researcher to be unsuitable for wearing frames, etc.); 7. Those who have participated in a drug clinical trial within 3 months and a device clinical trial within 1 month; 8. Those who have only one eye that meets the enrollment criteria; 9. Those who are unable to undergo regular eye examinations; 10. who have participated in any myopia control clinical research trial within three months, and who have previously used or are currently using rigid corneal contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses and other speciallv designed myopia control lenses, atropine-based lenses, and so on:; 11. Those who are judged by the investigator not to be eligible for enrollment.

Design outcomes

Primary

MeasureTime frame
equivalent spherical lens;

Secondary

MeasureTime frame
axilla (anatomy);corneal curvature;Crystal thickness;Choroidal thickness;anterior chamber depth(anatomy);Visual Questionnaire;

Countries

China

Contacts

Public ContactJian Ge

The Zhongshan Ophthalmic Center,Sun Yat-sen University

gejian@gzzoc.com+86 20 6661 0720

Outcome results

None listed

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