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Laser Assisted Procedures in Penetrating Keratoplasty

NCT02173847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-06-25

No results posted yet for this study

Summary

Laser- assisted procedures in penetrating keratoplasty (PK) are proposed to improve the surgical outcomes: minimally invasive procedures, improved biomechanical stability of the transplanted flap, reduction of rejection risks, reduction of inflammation, reduction of infections risk, faster healing process.

In order to achieve these goals, two different lasers were used during PK surgery:

* a femtosecond laser to cut an anvil shaped profile
* a diode laser to weld the surgical wound

Conditions

  • Keratoconus
  • Corneal Dystrophies
  • Corneal Opacity

Interventions

PROCEDURE

Penetrating keratoplasty

Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study

DEVICE

Femtosecond laser

A commercial femtosecond laser to cut a particular shaped graft

DEVICE

Diode laser

Low power, near infrared diode laser for welding the surgical wound

Sponsors & Collaborators

  • Istituto di Fisica Applicata

    collaborator UNKNOWN

  • Ospedale Santo Stefano

    lead OTHER

Principal Investigators

  • Luca Menabuoni, MD · Head of Corneal and Experimental Surgery at the Department of Ophthalmology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173847 on ClinicalTrials.gov