An interventional study of 3D collagen implant printed under GMP conditions. in Patients With Severe Corneal Melting, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Not applicable, Interventional, and Treatment
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.
The 3D-printed collagen will be used in clinical research as a biocompatible graft for the treatment of severe corneal melting, providing structural support and promoting epithelial regeneration without the need for more invasive transplants.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal is the lead sponsor of 82 studies on the registry; 21 are open to participants now.
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Absence of response to conventional non-surgical treatments, which must include:
The absence of response is not defined by a specific number of treatments, but by the lack of clinical improvement or progression of the condition despite having received several of these measures appropriately. In particular, progression of the epithelial defect, worsening stromal thinning, or the appearance of signs of perforation risk will be considered an absence of response, which would justify surgical intervention.
Exclusion Criteria:
Group A. 3D collagen implant printed under GMP conditions.
Device: 3D collagen implant printed under GMP conditions.
Given 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)
Time frame: During 12 months after the surgery
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)
Time frame: During 12 months after the surgery
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)
Time frame: During 12 months after the surgery
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.
Time frame: During 12 months after the surgery
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.
Time frame: During 12 months after the surgery
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)
Time frame: During 12 months after the surgery.
Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives)
Slit lamp biomicroscopy, evaluating: Loss of transparency (standardized subjective scale 0-3)
Time frame: During 12 months after the surgery
Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives)
Slit lamp biomicroscopy, evaluating: Presence of keratic precipitates, cells, and flare in the anterior chamber, if applicable.
Time frame: During 12 months after the surgery
Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives) by photograph
2\. Photograph of the anterior segment at each visit to document changes and allow for masked evaluation by external experts .
Time frame: During 12 months after the surgery
Quality of life scales: Visual quality and symptom questionnaires: Ocular Surface Disease Index (OSDI)
The questions are responsed as Scale: 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, 4 = All of the time. According to the sum total of the questions: Severity Levels: Normal (0-12), Mild (13-22), Moderate (23-32), Severe (33-100)
Time frame: 12 months since surgery
Quality of life scales: Visual quality and symptom questionnaires: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)
High Scores (close to 100): Indicate little to no impairment in that specific area of life. Low Scores (closer to 0): Indicate significant difficulty or dependency caused by poor vision.
Time frame: 12 months since surgery
Quality of life scales: Visual quality and symptom questionnaires: Eye pain and discomfort scales
Visual Analogue Scale (VAS) from 0 to 10 : Mild ( from 0 to 2), Moderate (from 3 to 7) and severe (from 8 to 10)
Time frame: 12 months since surgery
Quality of life scales: Visual quality and symptom questionnaires: Eye pain and discomfort scales: Symptom Likert scale
(0 = none, 4 = very severe) to assess burning, photophobia, foreign body sensation, and tearing.
Time frame: 12 months since surgery
No study locations are listed for this record.
Plan to share: No
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal