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Evaluation of the safety and efficacy of biological keratoprothesis in the treatment of infective keratitis

Multicenter clinical trial of the safety and efficacy of biotype keratoprothesis in the treatment of infectious keratitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037247
Enrollment
Unknown
Registered
2020-08-27
Start date
2013-12-08
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

Infectious keratitis

Interventions

experimental group:keratoplasty was performed using the biologic keratoprothesis

Sponsors

Wenzhou Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The lesion of infectious keratitis involves the corneal stroma; 2. Preoperative best corrected visual acuity < 0.05; 3. Age 18-80 years old, regardless of gender.

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) Patients with other diseases that affect vision; 5) Corneal perforator; 6) Corneal burns or chemical injuries; 7) Severe corneal neovascularization caused by corneal diseases; 8) Severe dry eye; 9) Incomplete eyelid closure; 10) Patients with severe allergies and/or allergies to the biological amnion; 11) Unable to accept materials of pig origin; 12)Pregnant women, lactating women, or women planning to become pregnant within 1 year; 13) 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.

Design outcomes

Primary

MeasureTime frame
best corrected visual acuity;Eye irritation symptoms;The transparency of the keratoprothesis;Corneal epithelium healing;The edema of the keratoprothesis;The dissolution and exfoliation of the keratoprothesis;Neovascularization of the keratoprothesis;vision rehabilitation rate;

Secondary

MeasureTime frame
Conjunctival congestion;Ciliary congestion;Anterior chamber floats;Intraocular pressure;

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