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Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

Primary Purpose

Advanced Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bowman layer graft implantation
Sponsored by
Netherlands Institute for Innovative Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Keratoconus focused on measuring Keratoconus, Bowman layer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

•Advanced keratoconus

Exclusion Criteria:

  • Further ophthalmic diseases
  • History of ocular surgery
  • Pregnancy, brest feeding

Sites / Locations

  • Netherlands Institute for Innovative Ocular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bowman layer graft implantation

Arm Description

Outcomes

Primary Outcome Measures

Corneal power
Reduction and stabilizing of the corneal power after Bowman layer graft implantation

Secondary Outcome Measures

Best corrected visual acuity

Full Information

First Posted
September 13, 2012
Last Updated
January 11, 2023
Sponsor
Netherlands Institute for Innovative Ocular Surgery
Collaborators
Amnitrans Eyebank Rotterdam
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1. Study Identification

Unique Protocol Identification Number
NCT01686906
Brief Title
Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus
Official Title
Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Netherlands Institute for Innovative Ocular Surgery
Collaborators
Amnitrans Eyebank Rotterdam

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Keratoconus
Keywords
Keratoconus, Bowman layer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bowman layer graft implantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bowman layer graft implantation
Intervention Description
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 Measure Information:
Title
Corneal power
Description
Reduction and stabilizing of the corneal power after Bowman layer graft implantation
Time Frame
2011-2020
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
2011-2020

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: •Advanced keratoconus Exclusion Criteria: Further ophthalmic diseases History of ocular surgery Pregnancy, brest feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerrit RJ Melles, MD, PhD
Organizational Affiliation
Netherlands Institute for Innovative Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Institute for Innovative Ocular Surgery
City
Rotterdam
ZIP/Postal Code
3071 AA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25596620
Citation
van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.
Results Reference
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PubMed Identifier
24557359
Citation
van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.
Results Reference
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PubMed Identifier
27362885
Citation
Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.
Results Reference
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PubMed Identifier
26077628
Citation
Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.
Results Reference
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PubMed Identifier
34620767
Citation
van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.
Results Reference
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Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

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