Skip to content

A non inferiority, multicenter, randomized, single blind, positive parallel controlled clinical trial of biological amniotic membrane for repairing superficial corneal defects

A non inferiority, multicenter, randomized, single blind, positive parallel controlled clinical trial of biological amniotic membrane for repairing superficial corneal defects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083009
Enrollment
Unknown
Registered
2024-04-12
Start date
2024-04-12
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Shallow corneal defects caused by various reasons

Interventions

Trial group:Using the experimental group's biological amniotic membrane
Control group:Using control group biological amniotic membrane

Sponsors

Beijing Tongren Hospital, CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients with superficial corneal defects caused by various reasons; (2) Age = 18 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 one-third of the thickness of the corneal layer; (2) Chemical or thermal burns with corneal limbal ischemia exceeding one-third; (3) Eye infections are in the active phase; (4) Glaucoma patients; (5) Patients with diabetes complicated with retinal detachment and other fundus diseases are not suitable for the group according to the judgment of the researcher; (6) Eyelid defects, incomplete closure of the eyelids, entropion of the eyelids, ectropion of the eyelids, and other eyelid abnormalities determined by the researcher as unsuitable for inclusion; (7) Severe allergic constitution or allergy to test materials and medication; (8) Pregnant, planned or breastfeeding women; (9) Individuals who have participated in clinical trials of other medical devices within one month, or have participated in drug clinical trials within three months; (10) Other situations that the researcher deems unsuitable for participation in this experiment.

Design outcomes

Primary

MeasureTime frame
Effective rate of repairing superficial corneal defects 28 days after surgery;

Secondary

MeasureTime frame
Corneal defect area;Amniotic membrane occupancy rate;Conjunctival congestion rating;Eye irritation symptoms;

Countries

China

Contacts

Public ContactYing Jie

Beijing Tongren Hospital, CMU

jie_yingcn@aliyun.com+86 136 9357 2296

Outcome results

None listed

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