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Evaluation of biological amnion for repair of superficial corneal defects: a randomized controlled trial.

Evaluation of wet and dry biological amnion for repair of superficial corneal defects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037234
Enrollment
Unknown
Registered
2020-08-27
Start date
2015-07-14
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

superficial corneal defects

Interventions

Experimental group ("wet" biological amnion group):The experimental group received the "wet" biological amnion produced by Guangzhou Youshiqing Biotechnology Co., LTD.
Control group ("dry" biological amnion group):The control group received the "dry" biological amnion produced by Jiangxi Ruiji Biological Engineering Technology Co., LTD.

Sponsors

Wenzhou Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients from the age of 18 to 65 years with superficial corneal injury caused by surgical wound, thermal burn, chemical injury and keratitis.

Exclusion criteria

Exclusion criteria: 1) Patients with severe heart, liver or kidney diseases; 2) patients with serious blood or endocrine diseases; 3) patients with mental disorders; 4) the primary disease was fungus or acanthamoeba infection; 5) deep stromal layer of cornea defect (defect depth greater than 1/3 corneal thickness); 6) patients with severe dry eye or chemical burns with limbal ischemia in excess of 1/4 quadrant; 7) patients with severe allergies and/or allergies to the biological amnion; 8) patients were not considered suitable by the investigator to participate in this clinical trial or had participated in any other clinical trial within 3 months. 9)pregnant women, lactating women, or women planning to become pregnant within 3 months.

Design outcomes

Primary

MeasureTime frame
the repair efficiency of superficial corneal injury at 21 days after surgery;

Secondary

MeasureTime frame
amniotic membrane in position;corneal defect area;corneal fluorescein sodium staining;eye irritation symptoms;Best corrected vision ;corneal vascular proliferation;conjunctival congestion;ciliary congestion;

Countries

China

Contacts

Public ContactWei Chen

Wenzhou Medical University Eye Hospital

1300956353@qq.com+86 13757728118

Outcome results

None listed

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