Femtosecond Laser-assisted Anterior Lamellar Keratoplasty

Not Applicable

Completed

• Conditions: Corneal Opacity; Keratoconus
• Interventions: Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)

• Registration Number: NCT02301598
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-09
• Study Completion: 2013-09
• Status Verified: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-22
• Study First Posted: 2014-11-26
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FS-ALK	FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)	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.

Primary Outcome Measures

Name	Time	Method
Mean endothelial cell loss	12 months after surgery
BSCVA (best spectacle-corrected visual acuity)	12 months after surgery
Mean postoperative astigmatism	12 months after surgery
UCVA (uncorrected visual acuity)	12 months after surgery

Secondary Outcome Measures

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