Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

Advanced Keratoconus Clinical Trial

Official title:

Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686906
• Other study ID #: NIIOS-BL-2012
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2020

Study information

• Verified date: January 2023
• Source: Netherlands Institute for Innovative Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

•Advanced keratoconus

Exclusion Criteria:

• Further ophthalmic diseases

• History of ocular surgery

• Pregnancy, brest feeding

Related Conditions & MeSH terms

• Advanced Keratoconus
• Keratoconus

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Netherlands Institute for Innovative Ocular Surgery	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Netherlands Institute for Innovative Ocular Surgery	Amnitrans Eyebank Rotterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal power	Reduction and stabilizing of the corneal power after Bowman layer graft implantation	2011-2020
Secondary	Best corrected visual acuity		2011-2020