Keratoconus Clinical Trial
Official title:
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
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
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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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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