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The effectiveness safety of corneal contact lens used to correct myopia :a multi-center, randomized, open and positive parallel control clinical trials.

The effectiveness safety of corneal contact lens used to correct myopia :a multi-center, randomized, open and positive parallel control clinical trials.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013794
Enrollment
Unknown
Registered
2017-12-09
Start date
2017-05-01
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

myopia

Interventions

1:contact lens2
2:contact lens2

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) patients aged between 8 and 40 years of myopia, including 8 and 40 years old 2) myopia is 4.00D or lower; 3) astigmatism with the rule is lower than 1.75d, and the astigmatism against the rule is lower than 1.00 D; 4) the best correction of visual acuity is not less than 20/20 ; 5) patients with corneal curvature at 40.00D ~ 46.00 D; 6) diopter stay stability before trial; 7) be able to complete at least 1 year follow-up, and wear contact lens for 8-10 hours per day; 8) patients who had not worn hard contact lenses (including corneal plastic lenses) in the past 2 months; 9) no clinical trial of other drugs or medical devices during the first 30 days of screening; 10) be able to understand the purpose of the experiment, volunteer to participate and sign the informed consent form by the patient himself or his legal guardian.

Exclusion criteria

Exclusion criteria: 1) with systemic disease cause low immunity, or an disease have effect on corneal shape of patients (such as acute and chronic sinusitis, diabetes and down syndrome, rheumatoid arthritis, psychiatric patients, etc.); 2) corneal abnomal; Has corneal surgery, or has a history of corneal trauma; Patients with hypocorneal sensory impairment (e.g. corneal infection, etc.); Having a history of ocular trauma or intraocular surgery; Patients with fundus lesions and other ocular organic diseases; 3) combined with other ocular diseases, such as dacryocystitis, xerophthalmia, conjunctivitis, blepharitis, etc. 4) pregnant, lactating or recently planned pregnancies; 5) patients who are using or need to use drugs that may cause dry eyes or affect visual and corneal curvature; 6) patients who are allergic to contact lens or contact lens care solution; 7) pupil diameter is greater than 6.2 mm; 8) the researchers judged that the patients were not suitable of other situations.

Design outcomes

Primary

MeasureTime frame
visual acurity;

Countries

China

Contacts

Public ContactFu Jing

Beijing Tongren Hospital, Capital Medical University

fu_jing@126.com+86 13801218591

Outcome results

None listed

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