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Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

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ClinicalTrials.gov Identifier: NCT01686906
Recruitment Status : Recruiting
First Posted : September 18, 2012
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Amnitrans Eyebank Rotterdam
Information provided by (Responsible Party):
Netherlands Institute for Innovative Ocular Surgery

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Keratoconus Procedure: Bowman layer graft implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Corneal power [ Time Frame: 2011-2020 ]
    Reduction and stabilizing of the corneal power after Bowman layer graft implantation


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


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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

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
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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
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Principal Investigator: Gerrit RJ Melles, MD, PhD Netherlands Institute for Innovative Ocular Surgery

Publications:
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Responsible Party: Netherlands Institute for Innovative Ocular Surgery
ClinicalTrials.gov Identifier: NCT01686906     History of Changes
Other Study ID Numbers: NIIOS-BL-2012
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases