Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05870566

UV Light-mediated Corneal Crosslinking as (Lymph)Angioregressive 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

52 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

Researchers are evaluating corneal crosslinking (CXL) as a pre-treatment before full-thickness penetrating corneal transplantation in patients with pathologically prevascularized corneas. The study aims to improve graft survival by reducing pathological corneal neovascularization (CoNV) before transplantation. This multicenter, randomized, controlled trial compares the outcomes of patients receiving CXL before surgery to those undergoing transplantation without pre-treatment. Participants in the intervention group will receive corneal crosslinking 8 to 10 weeks prior to transplantation, with a possible repeat treatment if less than 50% reduction of CoNV is observed. The control group will proceed directly to transplantation without CXL. Corneal transplantation involves securing the graft with nylon sutures, and in the intervention arm, fine needle diathermy may be used to occlude residual vessels if needed. In contrast, fine needle diathermy is not performed in the control group to avoid risks. During the study, participants will undergo baseline examinations including slit lamp assessments, corneal tomography, optical coherence tomography, visual acuity testing, and quality-of-life questionnaires. Follow-up visits occur at 3, 6, 12, 18, and 24 months after transplantation, with repeated evaluations and documentation to monitor graft function, CoNV regression, rejection episodes, and vision outcomes. Participants can contact the study site anytime with concerns, and additional visits may be scheduled as needed. The primary outcome is the time to first episode of endothelial graft rejection within 24 months post-transplantation.

CONDITIONS

Brief 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 requiring corneal transplantation
  • Adult male or female subjects aged 18 years or older
  • At least 2 corneal quadrants covered by pathological corneal neovascularization
  • Written informed consent obtained prior to study procedures
  • Cooperative attitude to follow study procedures
  • Only one eye included in case of bilateral disease
  • Steroid responders with controlled regimen or local/systemic therapy can participate
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 ultraviolet light
  • Contraindications to treatment or surgical protocols
  • Clinically significant or unstable concurrent medical conditions
  • Rheumatic diseases on systemic immunosuppressive medication
  • Unable to comply with study protocol or understand study scope
  • Participation in another investigational drug trial within 4 weeks
  • HIV positive status
  • Known substance abuse
  • Psychiatric or other medical conditions interfering with treatment
  • Sponsor employees or relatives of investigators
  • Pregnant or nursing women
  • Persons held in legal or official institutions
  • Dysregulated glaucoma with intraocular pressure over 25 mmHg despite therapy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Corneal Crosslinking Pretreatment

Duration - Up to 6 weeks before transplantation

Participants in the intervention group receive corneal crosslinking treatment to reduce corneal neovascularization 8 to 10 weeks before corneal transplantation. The treatment may be repeated once if insufficient response is observed.

1 to 2 visits including treatment and follow-up

Corneal Transplantation

Duration - 1 day

Participants undergo standard full-thickness penetrating corneal transplantation surgery.

1 visit (surgery day)

Post-operative Follow-up

Duration - 24 months

Participants are monitored after surgery with assessments of graft survival, visual acuity, and ocular health at regular intervals.

Visits at 3, 6, 12, 18, and 24 months post-transplant

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.

D

Deniz Hos, Dr.

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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Published Research Related To This Trial

UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial.

Johanna Wiedemann, Deniz Hos, Endrik Limburg...

https://pubmed.ncbi.nlm.nih.gov/38448965