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S. Dutta, R. M. Shtein, A. Sugar, S. Mian; Femtosecond Laser-Assisted Keratoplasty: A Pilot Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2206.
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To describe the visual and anatomic outcomes of patterned corneal grafts after femtosecond-laser assisted keratoplasty (FLAK).
Six eyes of six patients were prospectively enrolled in a trial to evaluate outcomes after femtosecond-laser assisted penetrating keratoplasty. Mushroom and top-hat patterns was used. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, corneal topography, and endothelial cell density were measured preoperatively, and 1, 3, and 6 months postoperatively. Clinical confocal microscopy and anterior segment optical coherence tomography (OCT) were used to assess wound healing.
Three month follow up of six eyes revealed significant improvement in UCVA from 20/200 to 20/50 (p=0.006) and positive trend in BSCVA from 20/50 to 20/30 (p=0.18). The endothelial cell density ranged between 1256 to 3291 cells/mm2 (mean 2415 ± 829 cells/mm2) three months postoperatively with a cell loss average of 22.19%. Preoperative and 3 month postoperative spherical equivalents were -7.90D and -3.04D, respectively (p=0.02). Six month follow up of four eyes also revealed significant improvement in UCVA from 20/200 to 20/60 (p=0.03) and a positive trend in BSCVA from 20/50 to 20/30 (p=0.14). The endothelial cell density at 6 months post surgery, ranged between 1051 to 3135 cells/mm2 (mean of 2004 ± 1030 cells/mm2) with an average cell loss of 33.63%. Preoperative and 6 month postoperative spherical equivalents were -7.90D and -3.70D, respectively. Assessment of wound healing at the graft host junction by OCT found that FLAK grafts were well positioned, with anterior and posterior graft-host mismatch decreasing over 6 months. Clinical confocal biomicroscopy revealed keratocyte activation postoperatively in all cases, primarily in the anterior stroma. Keratocyte activation diminished over 6 months. Needle-like opacities were observed by confocal biomicroscopy, primarily within the anterior stroma, with increased frequency in the periphery as compared to the central cornea.
Preliminary results describe femtosecond laser assisted keratoplasty with patterned corneal grafting as a safe and effective method for corneal transplantation. This technique offers well interposed graft-host interface and early wound healing.
Clinical Trial: :
www.clinicaltrials.gov HUM 15615-FLAK
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