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Non-inferior, multicenter, randomized, open, positive-parallel-controlled clinical trial of ophthalmic biological amniotic membrane for the repair of superficial cornea defects

Non-inferior, multicenter, randomized, open, positive-parallel-controlled clinical trial of ophthalmic biological amniotic membrane for the repair of superficial cornea defects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077705
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-11-21
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

superficial corneal defects

Interventions

Test group:Biological amniotic membrane for ophthalmology produced by Tido Biotechnology (Nanjing) Co., Ltd
Control group:Wet biological amniotic membrane produced by Jiangxi Ruiji Biotechnology Co., Ltd

Sponsors

Wenzhou Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Superficial cornea defects caused by various reasons; 2. Age range from 18 to 65 years old, regardless of gender; 3. Voluntarily participate in this experiment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. The depth of corneal defect is greater than 1/3 of corneal thickness; 2. Chemical or thermal burns with limbal ischemia exceeding 1/4; 3. Eye infection in active phase; 4. Combined eyelid abnormalities and glaucoma; 5. Severe allergic constitution or allergic to test materials and medication; 6. Pregnant, planned or lactating women; 7. Participated in other clinical trials within the past 3 months; 8. Other situations that the researcher deems unsuitable for participation in this experiment. Those who meet any of the above criteria cannot be included.

Design outcomes

Primary

MeasureTime frame
Effective rate of repairing superficial cornea defects,%;

Secondary

MeasureTime frame
Corneal defect area;Ocular symptom score;Amniotic membrane in-position rate;Conjunctival congestion rating; Best corrected visual acuity;

Countries

China

Contacts

Public ContactWei Chen

Eye System Of Wenzhou Medical University

1300956353@qq.com+86 577 8806 8878

Outcome results

None listed

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