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Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution (Other)
Overall Status
Completed
CT.gov ID
NCT02301598
Collaborator
(none)
13
Enrollment
1
Arm
20
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: FS-ALK

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.

Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Other Names:
  • Femto-ALK

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean endothelial cell loss [12 months after surgery]

    2. Mean postoperative astigmatism [12 months after surgery]

    3. UCVA (uncorrected visual acuity) [12 months after surgery]

    4. BSCVA (best spectacle-corrected visual acuity) [12 months after surgery]

    Secondary Outcome Measures

    1. Corneal hysteresis [12 months after surgery]

      Evaluation of biomechanical qualities of the cornea

    2. Corneal resistance factor [12 months after surgery]

      Evaluation of biomechanical qualities of the cornea

    3. Central corneal thickness [12 months after surgery]

      measured by OCT (optical coherence tomography - Optovue)

    4. Residual recipient's tissue thickness [12 months after surgery]

      measured by OCT (optical coherence tomography - Optovue)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 52 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The S.N. Fyodorov Eye Microsurgery State Institution

    Investigators

    • Study Director: Boris Malyugin, MD,PhD,prof., The S.N. Fedorof Federal State Institution

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexey Pashtaev, Alexey Pashtaev MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
    ClinicalTrials.gov Identifier:
    NCT02301598
    Other Study ID Numbers:
    • FS-1
    First Posted:
    Nov 26, 2014
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Alexey Pashtaev, Alexey Pashtaev MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
    femtosecond laser
    anterior lamellar keratoplasty
    atomic-force microscopy
    Additional relevant MeSH terms:
    Keratoconus
    Corneal Opacity

    Study Results

    No Results Posted as of Dec 2, 2014