NCT02301598

Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution · Other Government
• Sex: —
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Keratoconus
• Corneal Opacity

Interventions

Type	Name	Description
PROCEDURE	FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)	The procedure was a non-penetrating transplantation of 80% thickness corneal graft

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2013-09-01
• First posted: 2014-11-26
• Last updated: 2014-12-02