NCT01686906

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

9.9 years

First QC Date

September 13, 2012

Last Update Submit

January 11, 2023

Conditions

Advanced Keratoconus

Keywords

KeratoconusBowman layer

Outcome Measures

Primary Outcomes (1)

  • Corneal power

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

    2011-2020

Secondary Outcomes (1)

  • Best corrected visual acuity

    2011-2020

Study Arms (1)

Bowman layer graft implantation

EXPERIMENTAL
Procedure: Bowman layer graft implantation

Interventions

Bowman layer graft implantationPROCEDURE

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.

Bowman layer graft implantation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced keratoconus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Institute for Innovative Ocular Surgery

Rotterdam, 3071 AA, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 25596620BACKGROUND

  • 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.

    PMID: 24557359BACKGROUND

  • 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.

    PMID: 27362885BACKGROUND

  • 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.

    PMID: 26077628BACKGROUND

  • 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.

    PMID: 34620767BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Gerrit RJ Melles, MD, PhD

    Netherlands Institute for Innovative Ocular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

NL(1)