Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus
NCT ID: NCT01686906
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2011-01-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bowman layer graft implantation
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.
Interventions
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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 Criteria
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Inclusion Criteria
Exclusion Criteria
* History of ocular surgery
* Pregnancy, brest feeding
16 Years
ALL
No
Sponsors
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Amnitrans Eyebank Rotterdam
OTHER
Netherlands Institute for Innovative Ocular Surgery
OTHER
Responsible Party
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Principal Investigators
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Gerrit RJ Melles, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Netherlands Institute for Innovative Ocular Surgery
Locations
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Netherlands Institute for Innovative Ocular Surgery
Rotterdam, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NIIOS-BL-2012
Identifier Type: -
Identifier Source: org_study_id
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