We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

This study is currently recruiting participants.
Verified June 2015 by Netherlands Institute for Innovative Ocular Surgery
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686906
First Posted: September 18, 2012
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Amnitrans Eyebank Rotterdam
Information provided by (Responsible Party):
Netherlands Institute for Innovative Ocular Surgery
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    Reduction and stabilizing of the corneal power after Bowman layer graft implantation


Secondary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 2011-2020 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

•Advanced keratoconus

Exclusion Criteria:

  • Further ophthalmic diseases
  • History of ocular surgery
  • Pregnancy, brest feeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2012
First Posted: September 18, 2012
Last Update Posted: June 3, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases