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| ID | Type | Description | Link |
|---|---|---|---|
| 1500/25/EC-R | Other Identifier | AEMPS |
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| Name | Class |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | OTHER |
| Instituto de Investigación Sanitaria Gregorio Marañón | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only Group A. 3D collagen implant printed under GMP conditions. | Experimental | Group A. 3D collagen implant printed under GMP conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D collagen implant printed under GMP conditions. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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
| During 12 months after the surgery |
| Potential complications associated with the implant evaluated by Optical Coherence Tomography (OCT) | Biocompatibility assessment by OCT:
| During 12 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During 12 months after the surgery |
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Inclusion Criteria:
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.
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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Arnalich-Montiel, MD | Contact | +34913368126 | farnalich@gmail.com | |
| María P. De Miguel, MD | Contact | mariapdemiguel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Arnalich-Montiel, MD | Hospital Ramón y Cajal. Servicio de Oftalmología. Ctra. de Colmenar Km 9,100. 28034 Madrid | Study Director |
| María P. De Miguel, MD | Instituto de Investigaciones Sanitarias del Hospital Universitario La Paz, IdiPAZ, Madrid |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Stokking M, Cadenas-Martín M, Martín-González AI, Fernández-Ferrer A, Arnalich-Montiel F, De Miguel MP. (2025). Three-dimensional-printed collagen scaffold with limbal stem cells derived from adipose-derived mesenchymal stem cells for the treatment of limbal stem cell deficiency. Int J Bioprinting, 11(6), 407-429. doi:10.36922/IJB025290293 | ||
| 31856457 | Background | Deshmukh R, Stevenson LJ, Vajpayee R. Management of corneal perforations: An update. Indian J Ophthalmol. 2020 Jan;68(1):7-14. doi: 10.4103/ijo.IJO_1151_19. | |
| Background | 10. Koenig KR, et al. "Biomaterials for corneal regeneration: Current perspectives." J Biomed Mater Res. 2020. | ||
| 16331040 |
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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.
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|
| 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. | 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) | 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) | 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. | 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 . | 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) | 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. | 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) | 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. | 12 months since surgery |
| Background |
| Vajpayee RB, Singhvi A, Sharma N, Sinha R. Penetrating keratoplasty for perforated corneal ulcers: preservation of iris by corneal debulking. Cornea. 2006 Jan;25(1):44-6. doi: 10.1097/01.ico.0000177834.85507.28. |
| 26989954 | Background | Korah S, Selvin SS, Pradhan ZS, Jacob P, Kuriakose T. Tenons Patch Graft in the Management of Large Corneal Perforations. Cornea. 2016 May;35(5):696-9. doi: 10.1097/ICO.0000000000000808. |
| 15829790 | Background | Hick S, Demers PE, Brunette I, La C, Mabon M, Duchesne B. Amniotic membrane transplantation and fibrin glue in the management of corneal ulcers and perforations: a review of 33 cases. Cornea. 2005 May;24(4):369-77. doi: 10.1097/01.ico.0000151547.08113.d1. |
| 11927426 | Background | Solomon A, Meller D, Prabhasawat P, John T, Espana EM, Steuhl KP, Tseng SC. Amniotic membrane grafts for nontraumatic corneal perforations, descemetoceles, and deep ulcers. Ophthalmology. 2002 Apr;109(4):694-703. doi: 10.1016/s0161-6420(01)01032-6. |
| 9063239 | Background | Lee SH, Tseng SC. Amniotic membrane transplantation for persistent epithelial defects with ulceration. Am J Ophthalmol. 1997 Mar;123(3):303-12. doi: 10.1016/s0002-9394(14)70125-4. |
| 16181285 | Background | Sii F, Lee GA. Fibrin glue in the management of corneal melt. Clin Exp Ophthalmol. 2005 Oct;33(5):532-4. doi: 10.1111/j.1442-9071.2005.01076.x. |
| 2804032 | Background | Lagoutte FM, Gauthier L, Comte PR. A fibrin sealant for perforated and preperforated corneal ulcers. Br J Ophthalmol. 1989 Sep;73(9):757-61. doi: 10.1136/bjo.73.9.757. |
| 16310475 | Background | Setlik DE, Seldomridge DL, Adelman RA, Semchyshyn TM, Afshari NA. The effectiveness of isobutyl cyanoacrylate tissue adhesive for the treatment of corneal perforations. Am J Ophthalmol. 2005 Nov;140(5):920-1. doi: 10.1016/j.ajo.2005.04.062. |