Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01686906

Enrollment

Registered

2012-09-18

Start date

2011-01-31

Completion date

2020-12-31

Last updated

2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Keratoconus

Keywords

Keratoconus, Bowman layer

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

Interventions

PROCEDUREBowman 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

•Advanced keratoconus

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Corneal power	2011-2020	Reduction and stabilizing of the corneal power after Bowman layer graft implantation

Secondary

Measure	Time frame
Best corrected visual acuity	2011-2020

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026