Skip to content

Clinical trial to verify the effectiveness and safety of multiple micro-lens defocus structure lenses in clinical applications

Clinical trial to verify the effectiveness and safety of multiple micro-lens defocus structure lenses in clinical applications

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110438
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-26
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Myopia

Interventions

Test Group 1:Fit Hexagon Optimized Reticular Integration Lens
Test Group 2:Fit multipoint inter-lenslet eyecare Lens
Test Group 3:Fit Seewant Defocused Customized Myopia Spectacle Lens
Test Group 4:Fit STOP KIT Optical Film Lens

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Age: 6 - 14 years old. Gender: Open to all. 2. The refractive status meets the following conditions: a) After cycloplegia, the computerized refraction test shows that the equivalent spherical refractive power of both eyes is within the range of -0.50D to -6.00D (including -0.50D and -6.00D); b) After cycloplegia, the computerized refraction test shows that the astigmatism of both eyes is <= 2.0D; c) After cycloplegia, the computerized refraction test shows that the refractive anisometropia of both eyes is less than 2.00D; 3. The intraocular pressure of both eyes is within normal range (greater than or equal to 10 mmHg, and less than or equal to 21 mmHg); 4. The best corrected distant vision of either eye is superior to or equal to 1.0. 5. Both eyes have no amblyopia or any other pathological changes in the eye; 6. The patient himself is fully aware of and voluntarily participates in this research, and has signed the informed consent form with his own and his parents/guardians' signatures.

Exclusion criteria

Exclusion criteria: 1. One eye meets the inclusion criteria; 2. Any eye or systemic diseases that may be related to the development of myopia or affect the refractive state of the eye (such as congenital cataract, retinopathy of prematurity, Marfan syndrome, diabetes, etc.), or the treatment of the diseases with drugs may affect vision. 3. There is obvious strabismus or significant abnormal binocular visual function. 4. Unwilling to cooperate with the interviewer; 5. Other circumstances that led the researchers to determine that the patient was not eligible for inclusion;

Design outcomes

Primary

MeasureTime frame
Pyroglutamide;Axial length of the eye;

Secondary

MeasureTime frame
Fundus photography;Intraocular pressure;

Countries

China

Contacts

Public ContactPing Tang

Bejing Tongren Hospital, Capital Medical Uniersity

tp2200@vip.sina.com+86 18610023372

Outcome results

None listed

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