3D-Printed collagen implant to help severe corneal melting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional trial using a GMP-manufactured 3D-printed human collagen implant applied to the surface of the eye. The aim is to reinforce the cornea, support epithelial regeneration, and reduce the risk of perforation in patients with severe corneal melting. Eligible participants are adults who have not responded to conventional non-surgical therapies and have confirmed corneal thinning with progression. The implantation is designed to be biocompatible and transparent, minimizing rejection risk and avoiding more invasive transplant procedures. The study will monitor safety and any signals of efficacy in a controlled clinical setting at a major ophthalmology center in Madrid.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Ramón y Cajal
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: María P. De Miguel, MD — Instituto de Investigaciones Sanitarias del Hospital Universitario La Paz, IdiPAZ, Madrid
• Study coordinator: Francisco Arnalich-Montiel, MD
• Email: farnalich@gmail.com
• Phone: +34913368126

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving corneal graft resistance in artificial corneas

  This study is testing a new method using riboflavin and UV light to see if it can make artificial corneas last longer and prevent them from melting for people who can't have regular corneal transplants.

  Recruiting Centre hospitalier de l'Université de Montréal (CHUM) · Montreal, Quebec · NCT03041883

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.