Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
NCT ID: NCT02301598
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2012-01-31
2013-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FS-ALK
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.
FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Interventions
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FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal endothelial cell density
Exclusion Criteria
* Low endothelial cell density
* Age under 18 years
18 Years
52 Years
No
Sponsors
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The S.N. Fyodorov Eye Microsurgery State Institution
OTHER_GOV
Responsible Party
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Alexey Pashtaev
Alexey Pashtaev MD, PhD
Principal Investigators
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Boris Malyugin, MD,PhD,prof.
Role: STUDY_DIRECTOR
The S.N. Fedorof Federal State Institution
Other Identifiers
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FS-1
Identifier Type: -
Identifier Source: org_study_id