Corneal Opacity, Keratoconus
Conditions
Keywords
femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy
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.
Interventions
PROCEDUREFS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
Sponsors
The S.N. Fyodorov Eye Microsurgery State Institution
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Age
18 Years to 52 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BSCVA (best spectacle-corrected visual acuity) | 12 months after surgery |
| Mean endothelial cell loss | 12 months after surgery |
| Mean postoperative astigmatism | 12 months after surgery |
| UCVA (uncorrected visual acuity) | 12 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal hysteresis | 12 months after surgery | Evaluation of biomechanical qualities of the cornea |
| 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) |
| Residual recipient's tissue thickness | 12 months after surgery | measured by OCT (optical coherence tomography - Optovue) |
Outcome results
None listed