About this trial
Participants will be invited to participate in this clinical study because they have a severe corneal melting. An eye disease characterized by the progressive loss of the transparent tissue that covers the eye (the cornea). This condition can cause pain, vision loss, and risk of eye perforation. Furthermore, in some cases, the response to standard treatments is inadequate.
A piece of 3D-printed human collagen will be implanted on the affected surface of the eye in order to reinforce and protect it and prevent its progression to perforation.
The collagen piece is biocompatible, flexible, and transparent, designed to integrate naturally with the eye's tissues. Since it does not require a complete transplant or a human donor at the time of surgery, it reduces the risks of rejection and complications associated with other more invasive techniques.
Eligibility criteria
Qualifiers
Age over 18 years.
Patients who, after receiving detailed information about the design, purpose, risks, and implications of the study, and about their right to withdraw at any time without repercussions, give their informed written consent.
Confirmed diagnosis of severe corneal melting.
Intensive antibiotic, antifungal, or antiviral treatment according to etiology.
Disqualifiers
Pregnancy or breastfeeding.
Refusal to participate in the study.
Presence of active eye infection.
Systemic diseases that may affect healing.
Trial design
Treatments tested in this trial
- 3D collagen implant printed under GMP conditions.
Treatment groups
Locations
Sponsors and collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborator
Instituto de Investigación Sanitaria Gregorio Marañón
Collaborator