Clinical Trial: Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

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 Summary:

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.


Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution

Current Primary Outcome:

  • Mean endothelial cell loss [ Time Frame: 12 months after surgery ]
  • Mean postoperative astigmatism [ Time Frame: 12 months after surgery ]
  • UCVA (uncorrected visual acuity) [ Time Frame: 12 months after surgery ]
  • BSCVA (best spectacle-corrected visual acuity) [ Time Frame: 12 months after surgery ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Corneal hysteresis [ Time Frame: 12 months after surgery ]
    Evaluation of biomechanical qualities of the cornea
  • Corneal resistance factor [ Time Frame: 12 months after surgery ]
    Evaluation of biomechanical qualities of the cornea
  • Central corneal thickness [ Time Frame: 12 months after surgery ]
    measured by OCT (optical coherence tomography - Optovue)
  • Residual recipient's tissue thickness [ Time Frame: 12 months after surgery ]
    measured by OCT (optical coherence tomography - Optovue)


Original Secondary Outcome: Same as current

Information By: The S.N. Fyodorov Eye Microsurgery State Institution

Dates:
Date Received: November 20, 2014
Date Started: January 2012
Date Completion:
Last Updated: November 26, 2014
Last Verified: November 2014