MedTrace Logo

Evaluation of Biosynthetic Constructs to Replace Donor Corneas

NCT02374723 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-04-15

No results posted yet for this study

Summary

Constructs made from cross-linked Human Recombinant Collagen type III are being used instead of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients serve as controls and are receiving human donor corneas using the same surgical technique. The twelve patients will be recruited from the local waiting list for patients to be undergoing corneal grafting. If the patients meet the inclusion criteria and agree to participate following oral and written consent, they will be randomized to either group. The patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy, slit lamp photography a o. The study is planned as a safety study with initial efficacy documentation.

Conditions

  • Corneal Disease

Interventions

DEVICE

NuCornea

Deep anterior lamellar corneal transplantation where the NuCornea is substituting a donor cornea

DEVICE

donated human corneas

Deep anterior lamellar corneal transplantation with a donated cornea as graft material.

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Region Östergötland

    lead OTHER

Principal Investigators

  • Per Fagerholm, MD,PhD · Dept of Ophthalmology, University Hospital, Linköping,Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-04-30
Completion
2016-04-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374723 on ClinicalTrials.gov