Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02301598
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-11-20
Brief Title:
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Sponsor:
The SN Fyodorov Eye Microsurgery State Institution
Organization:
The SN Fyodorov Eye Microsurgery State Institution
Study Overview
Official Title:
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 recipients 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
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 recipients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None