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Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

Primary Purpose

Keratoconus, Corneal Opacity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
Sponsored by
The S.N. Fyodorov Eye Microsurgery State Institution
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy

Eligibility Criteria

18 Years - 52 Years (Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Advanced keratoconus or stromal corneal scattering
  • Normal endothelial cell density

Exclusion Criteria:

  • Acute keratoconus in the anamnesis
  • Low endothelial cell density
  • Age under 18 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FS-ALK

    Arm Description

    Femtosecond laser-assisted maximum thickness anterior lamellar keratoplasty (FS-ALK) was performed for 11 eyes of 11 patients with advanced keratoconus and 2 eyes of 2 patients with superficial corneal scattering.

    Outcomes

    Primary Outcome Measures

    Mean endothelial cell loss
    Mean postoperative astigmatism
    UCVA (uncorrected visual acuity)
    BSCVA (best spectacle-corrected visual acuity)

    Secondary Outcome Measures

    Corneal hysteresis
    Evaluation of biomechanical qualities of the cornea
    Corneal resistance factor
    Evaluation of biomechanical qualities of the cornea
    Central corneal thickness
    measured by OCT (optical coherence tomography - Optovue)
    Residual recipient's tissue thickness
    measured by OCT (optical coherence tomography - Optovue)

    Full Information

    First Posted
    November 20, 2014
    Last Updated
    November 26, 2014
    Sponsor
    The S.N. Fyodorov Eye Microsurgery State Institution
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02301598
    Brief Title
    Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
    Official Title
    Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The S.N. Fyodorov Eye Microsurgery State Institution

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities
    Detailed Description
    Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability. Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed. All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus, Corneal Opacity
    Keywords
    femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FS-ALK
    Arm Type
    Experimental
    Arm Description
    Femtosecond laser-assisted maximum thickness anterior lamellar keratoplasty (FS-ALK) was performed for 11 eyes of 11 patients with advanced keratoconus and 2 eyes of 2 patients with superficial corneal scattering.
    Intervention Type
    Procedure
    Intervention Name(s)
    FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
    Other Intervention Name(s)
    Femto-ALK
    Intervention Description
    The procedure was a non-penetrating transplantation of 80% thickness corneal graft
    Primary Outcome Measure Information:
    Title
    Mean endothelial cell loss
    Time Frame
    12 months after surgery
    Title
    Mean postoperative astigmatism
    Time Frame
    12 months after surgery
    Title
    UCVA (uncorrected visual acuity)
    Time Frame
    12 months after surgery
    Title
    BSCVA (best spectacle-corrected visual acuity)
    Time Frame
    12 months after surgery
    Secondary Outcome Measure Information:
    Title
    Corneal hysteresis
    Description
    Evaluation of biomechanical qualities of the cornea
    Time Frame
    12 months after surgery
    Title
    Corneal resistance factor
    Description
    Evaluation of biomechanical qualities of the cornea
    Time Frame
    12 months after surgery
    Title
    Central corneal thickness
    Description
    measured by OCT (optical coherence tomography - Optovue)
    Time Frame
    12 months after surgery
    Title
    Residual recipient's tissue thickness
    Description
    measured by OCT (optical coherence tomography - Optovue)
    Time Frame
    12 months after surgery

    10. Eligibility

    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Advanced keratoconus or stromal corneal scattering Normal endothelial cell density Exclusion Criteria: Acute keratoconus in the anamnesis Low endothelial cell density Age under 18 years
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Boris Malyugin, MD,PhD,prof.
    Organizational Affiliation
    The S.N. Fedorof Federal State Institution
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

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