Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Primary Purpose
Keratoconus, Corneal Opacity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FS-ALK
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean endothelial cell loss
Mean postoperative astigmatism
UCVA (uncorrected visual acuity)
BSCVA (best spectacle-corrected visual acuity)
Secondary Outcome Measures
Corneal hysteresis
Evaluation of biomechanical qualities of the cornea
Corneal resistance factor
Evaluation of biomechanical qualities of the cornea
Central corneal thickness
measured by OCT (optical coherence tomography - Optovue)
Residual recipient's tissue thickness
measured by OCT (optical coherence tomography - Optovue)
Full Information
NCT ID
NCT02301598
First Posted
November 20, 2014
Last Updated
November 26, 2014
Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
1. Study Identification
Unique Protocol Identification Number
NCT02301598
Brief Title
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Official Title
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The S.N. Fyodorov Eye Microsurgery State Institution
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Corneal Opacity
Keywords
femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FS-ALK
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
Other Intervention Name(s)
Femto-ALK
Intervention Description
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Primary Outcome Measure Information:
Title
Mean endothelial cell loss
Time Frame
12 months after surgery
Title
Mean postoperative astigmatism
Time Frame
12 months after surgery
Title
UCVA (uncorrected visual acuity)
Time Frame
12 months after surgery
Title
BSCVA (best spectacle-corrected visual acuity)
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Corneal hysteresis
Description
Evaluation of biomechanical qualities of the cornea
Time Frame
12 months after surgery
Title
Corneal resistance factor
Description
Evaluation of biomechanical qualities of the cornea
Time Frame
12 months after surgery
Title
Central corneal thickness
Description
measured by OCT (optical coherence tomography - Optovue)
Time Frame
12 months after surgery
Title
Residual recipient's tissue thickness
Description
measured by OCT (optical coherence tomography - Optovue)
Time Frame
12 months after surgery
10. Eligibility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Malyugin, MD,PhD,prof.
Organizational Affiliation
The S.N. Fedorof Federal State Institution
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
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