end-stage cornea blindness
Conditions
Interventions
Test group:Composite Keratoprosthesis Implantation
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients selected must have bilateral end-stage corneal blindness (including severe corneal vascularization due to severe eye chemical/thermal burns, complete limbal stem cell deficiency, end-stage dry eye caused by systemic autoimmune diseases (such as Stevens-Johnson syndrome, mucous membrane pemphigoid, GVHD, etc.), failure of more than two penetrating keratoplasties (with high vascularization and limbal stem cell deficiency), silicone oil-dependent corneal blindness, etc.). Other criteria include: 1. being at least 18 years old; 2. having visual potential in the surgical eye (with acceptable retinal and optic nerve structure and function); 3. no active eye infections; 4. fully understanding the indications, surgical risks, and other relevant information about artificial corneas; 5. being able to follow postoperative medication instructions and regular follow-up visits as required.
Exclusion criteria
Exclusion criteria: 1. No light perception; 2. Children, pregnant women (or those attempting pregnancy), and individuals with severe systemic diseases who cannot tolerate surgery; 3. Those who can achieve useful vision through corneal transplantation; 4. Individuals with severe mental illnesses; 5. Those with ocular conditions that severely affect visual recovery (e.g., old retinal detachment); 6. Patients and their families who do not understand the risks associated with artificial corneal surgery; 7. Those unable to adhere to medication regimens and regular follow-up reviews; 8. Individuals deemed unsuitable for participation in this clinical study by the investigator. Note: The first patient with poor preoperative visual potential, as assessed, is not excluded if the patient and their family are willing to proceed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morphological changes in the optic nerve and macula;Anterior segment photography;CFF; | — |
Countries
China
Contacts
Public ContactYifei Huang
Chinese PLA General Hospital.
Outcome results
None listed