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Clinical study on evaluating the effectiveness and safety of soft contact lens for myopia prevention and control in delaying myopia progression and relieving dry eye symptoms

Clinical research plan for evaluating the effectiveness and safety of defocus (cross lattice) soft contact lenses in slowing down myopia progression and antioxidant material soft contact lenses in relieving dry eye symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127545
Enrollment
Unknown
Registered
2026-07-02
Start date
2026-07-07
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

myopic

Interventions

Experimental group 1:Defocus soft contact lenses (single defocus ring with cross dot pattern)
Test group 6:Defocus Soft Contact Lens (Single-Ring Defocus, No Dot Pattern)
Experimental group 5:Lucida? Soft Hydrophilic Contact Lenses (No Defocus Ring, Cross Dot Pattern)
Experimental group 2:Rusq Clear? Dual-Clear? Soft Hydrophilic Contact Lenses (Multi-Ring Gradient Defocus with Cross Dot Pattern)
Control group:Single-vision soft hydrophilic contact lenses (no special optical design)
Experimental group 4:Lucida? Soft Hydrophilic Contact Lenses (No Defocus Ring, Cross Dot Pattern)
Experimental group 3:Lucida? Soft Hydrophilic Contact Lenses (No Defocus Ring, Cross Dot Pattern)

Sponsors

QINGDAO EYE HOSPITAL OF SHANDONG FIRST MEDICAL UNIVERSITY
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Age =6 years old and =16 years old (less than 16 years old at the time of initial screening), subject to the written consent of his guardian, regardless of sex; 2. The equivalent spherical power of objective optometry under mydriasis of both eyes is between -0.75 D and -5.00D (including -0.75D and -5.00D), the astigmatism is =1.50D, and the anisometropia of both eyes after equivalent spherical lens is = 1.50d; 3. The best corrected visual acuity of binocular subjective refraction is = 5.0; 4. Volunteer to participate in this clinical trial and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Have a history of intraocular surgery that affects wearing contact lenses; 2. Clinically significant slit lamp findings; 3. Abnormal fundus examination results; 4. Abnormal intraocular pressure (intraocular pressure 21mmhg); 5. Other eye diseases, such as uveitis and other inflammations, glaucoma, cataract, fundus diseases, eye tumors, Patients with ocular trauma and dominant strabismus, And any eye diseases that affect the visual function of the eyes; 6. Patients suffering from systemic diseases with low immunity (such as diabetes, Down syndrome, rheumatoid arthritis, mental illness) Diseases that patients or other researchers think are not suitable for wearing frame glasses); 7. Only one eye meets the selection criteria; 8. Those who cannot have regular eye examinations; 9. The researcher judges that other circumstances cannot be selected.

Design outcomes

Primary

MeasureTime frame
axial length;Refraction (objective refraction);

Secondary

MeasureTime frame
Ocular visual function;OCT (choroidal thickness);curvature;Questionnaire score;Objective visual quality (MTF);Tear film rupture time;Tear inflammatory factor;

Countries

China

Contacts

Public ContactXianli Du

QINGDAO EYE HOSPITAL OF SHANDONG FIRST MEDICAL UNIVERSITY

lilibestever@126.com+86 532 8589 9231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026