Patients With Severe Corneal Melting
Conditions
Keywords
Corneal melting
Brief summary
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.
Detailed description
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.
Interventions
DEVICE3D 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.
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Instituto de Investigación Hospital Universitario La Paz
Instituto de Investigación Sanitaria Gregorio Marañón
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This clinical investigation is a preliminary, exploratory, proof-of-concept study designed to evaluate the safety and feasibility of using 3D-printed collagen in patients with severe corneal melting. This is the first human administration of this implant, which is specifically designed to provide structural support in corneas with significant loss of thickness and risk of perforation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 18 years. 2. 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. 3. Confirmed diagnosis of severe corneal melting. 4. Absence of response to conventional non-surgical treatments, which must include: * Intensive antibiotic, antifungal, or antiviral treatment according to etiology. * Anti-inflammatory or immunomodulatory eye drops (such as corticosteroids, cyclosporine, tacrolimus). * Intensive lubrication and/or autologous serum. * Use of therapeutic contact lenses. * The patient must not have responded satisfactorily to these measures and must show progression or persistence of the ulcer, thinning, and structural risk. 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. 5. If the patient has previously undergone surgical procedures or received other implants (such as amniotic membrane, conjunctival flap, or Tenon's graft), this will be included if there is documented clinical progression without sufficient functional or structural recovery, and provided that there are no surgical alternatives with documented superior efficacy in their specific situation.
Exclusion criteria
1. Pregnancy or breastfeeding. 2. Refusal to participate in the study. 3. Presence of active eye infection. 4. Systemic diseases that may affect healing. 5. Known hypersensitivity to collagen compounds. 6. Any circumstance that, in the investigator's opinion, makes the patient's participation in the clinical research inadvisable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | During 12 months after the surgery | Incidence and severity of adverse reactions (safety and biocompatibility) |
| Biocompatibility assessment: potential complications associated with the implant evaluated by slit lamp biomicroscopy | During 12 months after the surgery | 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) | During 12 months after the surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the rate and time of corneal epithelial re-epithelization after implantation | During 12 months after the surgery | 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 | During 12 months after the surgery | 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) | During 12 months after the surgery. | 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) by photograph | During 12 months after the surgery | 2\. Photograph of the anterior segment at each visit to document changes and allow for masked evaluation by external experts . |
| Quality of life scales: Visual quality and symptom questionnaires: Ocular Surface Disease Index (OSDI) | 12 months since surgery | 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) |
| Quality of life scales: Visual quality and symptom questionnaires: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | 12 months since surgery | 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. |
| Quality of life scales: Visual quality and symptom questionnaires: Eye pain and discomfort scales | 12 months since surgery | Visual Analogue Scale (VAS) from 0 to 10 : Mild ( from 0 to 2), Moderate (from 3 to 7) and severe (from 8 to 10) |
| Quality of life scales: Visual quality and symptom questionnaires: Eye pain and discomfort scales: Symptom Likert scale | 12 months since surgery | (0 = none, 4 = very severe) to assess burning, photophobia, foreign body sensation, and tearing. |
Contacts
CONTACTFrancisco Arnalich-Montiel, MD
CONTACTMaría P. De Miguel, MD
STUDY_DIRECTORFrancisco Arnalich-Montiel, MD
Hospital Ramón y Cajal. Servicio de Oftalmología. Ctra. de Colmenar Km 9,100. 28034 Madrid
PRINCIPAL_INVESTIGATORMaría P. De Miguel, MD
Instituto de Investigaciones Sanitarias del Hospital Universitario La Paz, IdiPAZ, Madrid
Outcome results
None listed