Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
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|ClinicalTrials.gov Identifier: NCT02301598|
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus Corneal Opacity||Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Femtosecond Laser-assisted Anterior Lamellar Keratoplasty|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2013|
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.
Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Other Name: Femto-ALK
- Mean endothelial cell loss [ Time Frame: 12 months after surgery ]
- Mean postoperative astigmatism [ Time Frame: 12 months after surgery ]
- UCVA (uncorrected visual acuity) [ Time Frame: 12 months after surgery ]
- BSCVA (best spectacle-corrected visual acuity) [ Time Frame: 12 months after surgery ]
- Corneal hysteresis [ Time Frame: 12 months after surgery ]Evaluation of biomechanical qualities of the cornea
- Corneal resistance factor [ Time Frame: 12 months after surgery ]Evaluation of biomechanical qualities of the cornea
- Central corneal thickness [ Time Frame: 12 months after surgery ]measured by OCT (optical coherence tomography - Optovue)
- Residual recipient's tissue thickness [ Time Frame: 12 months after surgery ]measured by OCT (optical coherence tomography - Optovue)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301598
|Study Director:||Boris Malyugin, MD,PhD,prof.||The S.N. Fedorof Federal State Institution|