Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

This study is currently recruiting participants.
Verified September 2012 by Netherlands Institute for Innovative Ocular Surgery
Sponsor:
Collaborator:
Amnitrans Eyebank Rotterdam
Information provided by (Responsible Party):
Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier:
NCT01686906
First received: September 13, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus


Condition Intervention
Advanced Keratoconus
Procedure: Bowman layer graft implantation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus

Resource links provided by NLM:


Further study details as provided by Netherlands Institute for Innovative Ocular Surgery:

Primary Outcome Measures:
  • Corneal power [ Time Frame: 2011-2020 ] [ Designated as safety issue: No ]
    Reduction and stabilizing of the corneal power after Bowman layer graft implantation


Secondary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 2011-2020 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bowman layer graft implantation Procedure: Bowman layer graft implantation
For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

•Advanced keratoconus

Exclusion Criteria:

  • Further ophthalmic diseases
  • History of ocular surgery
  • Pregnancy, brest feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686906

Locations
Netherlands
Netherlands Institute for Innovative Ocular Surgery Recruiting
Rotterdam, Netherlands, 3071 AA
Contact: Kim Herders, MSc    +31-10-297 ext 4444    herders@niios.com   
Principal Investigator: Gerrit RJ Melles, MD, PhD         
Sponsors and Collaborators
Netherlands Institute for Innovative Ocular Surgery
Amnitrans Eyebank Rotterdam
Investigators
Principal Investigator: Gerrit RJ Melles, MD, PhD Netherlands Institute for Innovative Ocular Surgery
  More Information

No publications provided

Responsible Party: Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier: NCT01686906     History of Changes
Other Study ID Numbers: NIIOS-BL-2012
Study First Received: September 13, 2012
Last Updated: September 13, 2012
Health Authority: The Netherlands: Independent Ethics Committee

Keywords provided by Netherlands Institute for Innovative Ocular Surgery:
Keratoconus
Bowman layer

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014