Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05870566

Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

Led by Claus Cursiefen · Updated on 2024-10-21

110

Participants Needed

7

Research Sites

253 weeks

Total Duration

On this page

Sponsors

C

Claus Cursiefen

Lead Sponsor

U

Uniklinik Köln, Zentrum für Klinische Studien

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial evaluates the effect of corneal crosslinking as pre-treatment before corneal transplantation. The goal is to improve graft survival by reducing pathological vessels through pre-treatment.

CONDITIONS

Official Title

Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically prevascularized cornea with need for corneal transplantation
  • Written informed consent given before any study procedures
  • Adults aged 18 years or older
  • At least 2 corneal quadrants covered by pathological corneal neovascularization
  • No clinical contraindications to any part of the treatment plan
  • Willingness to cooperate and follow study procedures
  • Only one eye included if both eyes affected
  • Steroid responders can participate if controlled by therapy
Not Eligible

You will not qualify if you...

  • Less than 2 corneal quadrants covered by pathological neovascularization
  • Corneal stromal thickness below 400 bcm except in central 8 mm zone
  • Active or suspected intraocular inflammation
  • Active corneal ulceration
  • Compromised eyelid mobility or symblepharon
  • Allergy or intolerance to riboflavin or UV light
  • Contraindications to antibiotics, corticosteroids, or surgical protocol
  • Clinically significant or unstable diseases affecting grafting
  • Rheumatic diseases on systemic immunosuppressants
  • Unable to comply with study protocol or understand study procedures
  • Participation in another investigational drug trial within 4 weeks
  • HIV positive
  • Known abuse of alcohol, drugs, or medicines
  • Any medical or psychiatric condition affecting compliance or safety
  • Employees or relatives of sponsor or investigator
  • Pregnant or nursing women
  • Persons legally institutionalized
  • Dysregulated glaucoma with intraocular pressure > 25 mmHg despite therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Augenklinik des Klinikums der Universität München

München, Bavaria, Germany, 80336

Actively Recruiting

2

University Hospital of Cologne, Centre for Ophthalmology

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

3

Universitätsklinikum Düsseldorf, Klinik für Augenheilkunde

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

4

Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde

Homburg, Saarland, Germany, 66424

Actively Recruiting

5

Charité - Universitätsmedizin Berlin, Klinik für Augenheilkunde

Berlin, Germany, 13353

Actively Recruiting

6

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

7

Klinik und Poliklinik für Augenheilkunde - Universitätsmedizin Rostock

Rostock, Germany, 18057

Actively Recruiting

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Research Team

C

Claus Cursiefen, Prof. Dr.

CONTACT

D

Deniz Hos, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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