Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

This study is currently recruiting participants. (see Contacts and Locations)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Netherlands Institute for Innovative Ocular Surgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 24, 2014