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A randomized controlled trial comparing femtosecond-enabled deep anterior lamellar keratoplasty and standard deep anterior lamellar keratoplasty (FEDS Study).
Sorkin, Nir; Hatch, Wendy; Mimouni, Michael; Chew, Hall F; Rootman, David S; Slomovic, Allan R; Bujak, Matthew C; Chan, Clara C; Thorpe, Kevin E; Perez, Mauricio; Stiuso, Vera; Singal, Neera.
Afiliación
  • Sorkin N; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada. nir.sorkin@gmail.com.
  • Hatch W; Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. nir.sorkin@gmail.com.
  • Mimouni M; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
  • Chew HF; Kensington Eye Institute, Toronto, ON, Canada.
  • Rootman DS; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
  • Slomovic AR; Department of Ophthalmology, Rambam Health Care Campus affiliated with the Bruce and Ruth Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
  • 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; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
  • Perez M; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
  • Stiuso V; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada.
  • Singal N; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Eye (Lond) ; 37(13): 2693-2699, 2023 09.
Article en En | MEDLINE | ID: mdl-36693916
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Astigmatismo / Trasplante de Córnea / Queratocono Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Eye (Lond) Asunto de la revista: OFTALMOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Astigmatismo / Trasplante de Córnea / Queratocono Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: Eye (Lond) Asunto de la revista: OFTALMOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido