An interventional study of FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty) in Keratoconus and Corneal Opacity, sponsored by The S.N. Fyodorov Eye Microsurgery State Institution. Completed. Open to participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by The S.N. Fyodorov Eye Microsurgery State Institution · Not applicable, Interventional, and Treatment
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →The S.N. Fyodorov Eye Microsurgery State Institution is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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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
Also known as: Femto-ALK
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
Corneal hysteresis
Evaluation of biomechanical qualities of the cornea
Time frame: 12 months after surgery
Corneal resistance factor
Evaluation of biomechanical qualities of the cornea
Time frame: 12 months after surgery
Central corneal thickness
measured by OCT (optical coherence tomography - Optovue)
Time frame: 12 months after surgery
Residual recipient's tissue thickness
measured by OCT (optical coherence tomography - Optovue)
Time frame: 12 months after surgery
No study locations are listed for this record.
The record gives a start of Jan 2012, a primary completion of Sep 2012 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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The S.N. Fyodorov Eye Microsurgery State Institution