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Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

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ClinicalTrials.gov Identifier: NCT02301598
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Alexey Pashtaev, The S.N. Fyodorov Eye Microsurgery State Institution

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
Keratoconus Corneal Opacity Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


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 Name: Femto-ALK




Primary Outcome Measures :
  1. Mean endothelial cell loss [ Time Frame: 12 months after surgery ]
  2. Mean postoperative astigmatism [ Time Frame: 12 months after surgery ]
  3. UCVA (uncorrected visual acuity) [ Time Frame: 12 months after surgery ]
  4. BSCVA (best spectacle-corrected visual acuity) [ Time Frame: 12 months after surgery ]

Secondary Outcome Measures :
  1. Corneal hysteresis [ Time Frame: 12 months after surgery ]
    Evaluation of biomechanical qualities of the cornea

  2. Corneal resistance factor [ Time Frame: 12 months after surgery ]
    Evaluation of biomechanical qualities of the cornea

  3. Central corneal thickness [ Time Frame: 12 months after surgery ]
    measured by OCT (optical coherence tomography - Optovue)

  4. Residual recipient's tissue thickness [ Time Frame: 12 months after surgery ]
    measured by OCT (optical coherence tomography - Optovue)



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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301598


Sponsors and Collaborators
The S.N. Fyodorov Eye Microsurgery State Institution
Investigators
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Study Director: Boris Malyugin, MD,PhD,prof. The S.N. Fedorof Federal State Institution

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Responsible Party: Alexey Pashtaev, Alexey Pashtaev MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
ClinicalTrials.gov Identifier: NCT02301598     History of Changes
Other Study ID Numbers: FS-1
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Alexey Pashtaev, The S.N. Fyodorov Eye Microsurgery State Institution:
femtosecond laser
anterior lamellar keratoplasty
atomic-force microscopy

Additional relevant MeSH terms:
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Keratoconus
Corneal Opacity
Corneal Diseases
Eye Diseases