Infectious keratitis (caused by bacteria and fungi)
Conditions
Interventions
Treatment Group:Perform a new artificial cornea transplant
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged = 18 and = 75 years on the day of screening; 2. Patients with infectious keratitis (bacterial or fungal keratitis) whose lesions involve the corneal stroma but have not yet affected all layers of the cornea; 3. Patients who have been treated with medication (for more than 2 weeks) yet the treatment is invalid, especially whose infection has not been controlled; or clinicians consider that there is an indication for surgery (such as eye opacities or corneal leukoplakia formed after the infection is stablized); 4. Preoperative best corrected visual acuity < 0.05; 5. Voluntarily sign an informed consent form and willing to comply with all research procedures.
Exclusion criteria
Exclusion criteria: 1. Viral keratitis; 2. Severe endophthalmitis; 3. Individuals with severe damage of corneal limbus; 4. Corneal perforation; 5. Severe corneal vascularization; 6. Lagophthalmos; 7. Severe dry eyes, organic lesions of the eye, or other eye diseases such as secondary glaucoma that may cause graft failure; 8. Individuals with immune-mediated corneal diseases, ocular conditions associated with neuroparalytic keratitis, or other visual impairments; 9. Monocular patients or patients with bilateral blindness; 10. Individuals with severe heart, liver or kidney diseases, individuals with severe blood or endocrine diseases (such as severe diabetes (a fasting blood sugar level > 8 mmol/L after managing the blood sugar level), or individuals with severe autoimmune diseases; 11. Collagen-related connective tissue disorders; 12. Individuals with malignant neoplasms; 13. Individuals with severe allergies and/or allergies to test materials; 14. Individuals with mental illness; 15. Individuals with hypoalbuminemia; 16. Women who are pregnant, nursing or may become pregnant during the study period; 17. Individuals who have participated in clinical trials of drug or other medical devices within 3 months; 18. Other circumstances that the researcher considers inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sight Restoration Rate at Day 360 Post-op (±30 days) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity;Graft Clarity;Proportion that eye infection is under control;Graft Edema;Epithelial Healing;Neovascularization;Device retention rate;Eye Irritation;Conjunctival Hyperemia;The occurrence of Floaters in the anterior chamber;Corneal graft melting;Transplant rejection;The incidence (%) and number of (serious) adverse events;The incidence (%) and number of device related (serious) adverse events;The incidence (%) and number of device defects;The incidence (%) and number of secondary surgery ;Intraocular pressure; | — |
Countries
China
Contacts
Public ContactYing Jie
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed