Corneal ulcer
Conditions
Brief summary
The main efficacy variable will be the capacity of NANOULCOR to regenerate the trophic defect, compared to the control group. For this purpose, the difference between the two treatment groups will be assessed in the percentage of patients in whom the epithelial defect disappears. The status of the trophic defect will be assessed at all visits
Detailed description
Effectiveness Time to healing, Changes in visual acuity, Incidence of corneal complications according to the SOTOZONE scale, Changes in the patient's quality of life. Security Occurrence of AE and SAE. Status of the implanted corneal construct: maintenance of its integrity, detachment or resorption. Feasibility The percentage of patients in whom treatment with NANOULCOR has been feasible shall be recorded, including all points in the process
Sponsors
Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main efficacy variable will be the capacity of NANOULCOR to regenerate the trophic defect, compared to the control group. For this purpose, the difference between the two treatment groups will be assessed in the percentage of patients in whom the epithelial defect disappears. The status of the trophic defect will be assessed at all visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness Time to healing, Changes in visual acuity, Incidence of corneal complications according to the SOTOZONE scale, Changes in the patient's quality of life. Security Occurrence of AE and SAE. Status of the implanted corneal construct: maintenance of its integrity, detachment or resorption. Feasibility The percentage of patients in whom treatment with NANOULCOR has been feasible shall be recorded, including all points in the process | — |
Countries
Spain
Outcome results
None listed