A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).

Autor: Sorkin N; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada. nir.sorkin@gmail.com.; Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. nir.sorkin@gmail.com., Hatch W; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.; Kensington Eye Institute, Toronto, ON, Canada., Mimouni M; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.; Department of Ophthalmology, Rambam Health Care Campus affiliated with the Bruce and Ruth Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel., Chew HF; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada., Rootman DS; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada., Slomovic AR; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada., Bujak MC; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada., Chan CC; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada., Thorpe KE; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.; Applied Health Research Centre (AHRC), Toronto, ON, Canada., Perez M; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada., Stiuso V; Kensington Eye Institute, Toronto, ON, Canada., Singal N; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.; Kensington Eye Institute, Toronto, ON, Canada.
Jazyk: angličtina
Zdroj: Eye (London, England) [Eye (Lond)] 2023 Sep; Vol. 37 (13), pp. 2693-2699. Date of Electronic Publication: 2023 Jan 24.
DOI: 10.1038/s41433-023-02387-1
Abstrakt: Objectives: To compare outcomes of femtosecond-enabled deep anterior lamellar keratoplasty (FE-DALK) and standard deep anterior lamellar keratoplasty (S-DALK).
Methods: An open label, randomized controlled trial (Kensington Eye Institute, Toronto, ON, Canada) including 100 eyes of 97 participants with either keratoconus or corneal scarring, randomized to either FE-DALK (n = 48) or S-DALK (n = 49).
Primary Outcomes: postoperative astigmatism and surgically induced corneal astigmatism (SIA) - both at 15 months.
Secondary Outcomes: 6-, 12- and 15-month postoperative uncorrected- and best spectacle-corrected visual acuity, steep and flat keratometry, manifest sphere and astigmatism, rate of conversion to penetrating keratoplasty (PK), big-bubble success, central corneal thickness, endothelial cell count and complications.
Results: In intention-to-treat analysis, mean postoperative astigmatism in the FE-DALK (n = 30) and S-DALK (n = 30) groups at 15 months was 7.8 ± 4.4 D and 6.3 ± 5.0 D, respectively (p = 0.282) with an adjusted mean difference of 1.3 D (95% CI -1.08, +3.65). Mean SIA (arithmetic) was 9.2 ± 7.8 and 8.8 ± 5.4 D, respectively (p = 0.838) with a mean difference of 0.4 D (95% CI -3.13, +3.85). In an analysis of successful DALK cases only, mean postoperative astigmatism in the FE-DALK (n = 24) and S-DALK (n = 20) groups at 15 months (after excluding 4 eyes with AEs) was 7.3 ± 4.4 and 6.2 ± 4.9 D, respectively (p = 0.531) with an adjusted mean difference of 0.9 D (95% CI -1.94, +3.71). Mean SIA (arithmetic) was 9.1 ± 7.8 and 7.9 ± 4.6 D, respectively (p = 0.547) with a mean difference of 1.2 D (95% CI -2.70,+5.02). Comparison of secondary outcomes showed only weak statistical evidence.
Conclusions: In this randomized controlled trial, FE-DALK and S-DALK showed comparable functional and anatomical outcomes.
(© 2023. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.)
Databáze: MEDLINE
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