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Clinical trial on the safety and effectiveness of decellular artificial corneal treatment for infectious corneal disease

Clinical trial on the safety and effectiveness of decellular artificial corneal treatment for infectious corneal disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075296
Enrollment
Unknown
Registered
2023-08-31
Start date
2015-04-30
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

The lesion does not involve the whole layer of infectious corneal disease

Interventions

Experimental Group:Acellular keratoplasty

Sponsors

Henan Provincial Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The best corrected vision before surgery is <0.05; the corneal lesion is located in the pupil area. (2) The lesion involves the corneal matrix, but has not yet affected the entire corneal layer of infectious corneal disease (fungal, bacterial, viral)Sexual and spinous amoeba keratitis patients; (3) 18 to 80 years old, male or female; (4) Informed consent: The doctor shall inform the relevant content of the clinical trial in detail, and the patient shall agree and sign the informed consent form. (5) Patients whose infection has not been controlled after more than 2 weeks of non-surgical treatment.

Exclusion criteria

Exclusion criteria: (1) Serious heart, liver, kidney and other important organ diseases; (2) Severe blood and endocrine system diseases and medical history; (3) Mentally abnormal people; (4) Combined with other diseases that affect vision; (5) Corneal perforation; (6) Corneal burns or chemical injuries; (7) Patients with severe vascularization of the cornea caused by corneal diseases; (8) Severe dry eye; (9) Incomplete closure of the eyelids; (10) Severe allergic constitution and/or allergic to test materials; (11) Patients with infectious endophthalmitis; (12) Patients with monocular or loss of vision in the opposite eye; (13) Patients with collagen connective tissue disease throughout the body; (14) Those who cannot accept pig-derived materials because of religious beliefs; (15) Pregnant women, lactation, or women who plan to prepare for pregnancy within 1 year; (16) Researchers believe that it is not suitable for participants in this clinical trial; (17) Those who have participated in any other clinical trials within three months.

Design outcomes

Primary

MeasureTime frame
De-blindness rate;

Secondary

MeasureTime frame
Postoperative observation time: 3 days after operation, 7 days after operation, 30 days, 60 days, 90 days, 180 days, 360 days Except for 6 months after operation, that is, 180 days after operation (visit 6), the visual acuity of other visiting points. All follow-up points: ocular irritation, conjunctival congestion, corneal epithelial healing, control of primary infection, cornea. Transparency, corneal edema, corneal neovascularization, corneal dissolution or exfoliation, slit lamp examination a;

Countries

China

Contacts

Public ContactLiyaWang

Henan Provincial Eye Hospital

zhanglei@ushinemed.com+86 198 3999 0163

Outcome results

None listed

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