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.
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.
Pregnancy or breastfeeding.
Refusal to participate in the study.
Presence of active eye infection.
Systemic diseases that may affect healing.
Single group
3D collagen implant printed under GMP conditions.
DeviceGiven its exploratory nature, the study does not propose an equivalence threshold compared to standard treatments, but rather seeks to confirm the safety and clinical viability of the implant. It is expected that 3D-printed collagen will provide superior stromal support, with greater transparency and stability than other reconstructive techniques, such as amniotic membrane, conjunctival flaps, or tectonic grafts.
Incidence and severity of adverse reactions to evaluate the safety and biocompatibility of 3D-printed collagen in the corneal stroma of patients with severe corneal melting.
Incidence and severity of adverse reactions (safety and biocompatibility)
Biocompatibility assessment: potential complications associated with the implant evaluated by slit lamp biomicroscopy
Biocompatibility assessment by slit lamp biomicroscopy * Epithelial status: Not assessable , Reason: Lens /Tarsorrhaphy/ Edema or Other // Assessable : Epithelial defect present: Yes /No, Size of defect (if assessable) mm², Edges: Regular/ Irregular * Overall corneal edema: Mild /Moderate / Severe * Infiltrate: No /Yes (describe) * Vascularization (scale 0-3) * Secretion: Absent /Mild /Moderate / Profuse * Signs of infection: No / Yes (describe)
Potential complications associated with the implant evaluated by Optical Coherence Tomography (OCT)
Biocompatibility assessment by OCT: * If the graft is present: Integration (Adequate/Partial/Displacement/ Graft edema/ Partial resorption) // Minimum thickness ( µm) * If the graft is no longer present: ( Graft not visible/resorbed)
Determine the rate and time of corneal epithelial re-epithelization after implantation
Corneal re-epithelization rate and time measured with fluorescein staining. This will be measured as the area of the epithelial defect expressed in mm², which will allow both the rate of re-epithelialization and the time to complete closure to be calculated.
Determine the rate and time of corneal epithelial re-epithelialization after implantation
Corneal thickness achieved in the area of corneal thinning by melting using Optical Coherence Tomography (OCT). This will be measured in μm.
Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives)
Slit lamp biomicroscopy, evaluating:Presence and degree of conjunctival hyperemia (scale of 0 to 3) and Stromal edema (scale 0-3)
Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives)
Slit lamp biomicroscopy, evaluating: Loss of transparency (standardized subjective scale 0-3)
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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
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