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OpenTrials
Completed

NCT Number: NCT01686906

Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus

To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus

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Key information

Conditions

Advanced Keratoconus Corneal Diseases Eye Diseases Keratoconus

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Institute for Innovative Ocular Surgery

Rotterdam, 3071 AA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

•Advanced keratoconus

Exclusion criteria

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

Treatment and study plan

Bowman layer graft implantation

Procedure

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 outcomes

  1. Corneal power

    Time frame: 2011-2020

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

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: 2011-2020

Sponsors and collaborators

Lead sponsor

Netherlands Institute for Innovative Ocular Surgery

Other

Collaborators

  • Amnitrans Eyebank Rotterdam

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2012
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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