Corneal trophic ulcers refractory to conventional treatment or sequelae of previous ulcers (such as stromal thinning or fibrosis), associated or not with limbal insufficiency of the same eye.
Conditions
Brief summary
Incidence of adverse events and severe adverse events related with the IMP., Graft conditions (artificial cornea): integrity, graft survival or reabsorption., Local, regional or systemic infection signs., Induced corneal vascularization.
Detailed description
Ulcer persistence or regeneration of corneal stroma., Visual acuity., Corneal transparency., Quality of life (EQ5, part I and II)., Characterization of corneal surface (impression citology & OCT mapping).
Interventions
Sponsors
Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and severe adverse events related with the IMP., Graft conditions (artificial cornea): integrity, graft survival or reabsorption., Local, regional or systemic infection signs., Induced corneal vascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcer persistence or regeneration of corneal stroma., Visual acuity., Corneal transparency., Quality of life (EQ5, part I and II)., Characterization of corneal surface (impression citology & OCT mapping). | — |
Countries
Spain
Outcome results
None listed