BACKGROUND: To investigate the difference in clinical outcomes between large-diameter deep anterior lamellar keratoplasty (L-DALK) and standard DALK (S-DALK) for the treatment of keratoconus. METHODS:132 patients (132 eyes) from the Zhongshan Ophthalmic Center with a clinical diagnosis of keratoconus were enrolled. The participants were featured by the intolerance to rigid gas-permeable contact lenses or unsuccessful fitting of contact lenses. Using stratified blocked randomisation, eligible eyes were allocated into the L-DALK group or the S-DALK group (66 eyes, respectively). Postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refractive sphere, manifest cylinder and spherical equivalent refractive error were tested at 6, 12, 18 and 24 months after surgery. RESULTS: After surgery, the L-DALK group had better UCVA and BSCVA than the S-DALK group (p=0.000 and 0.021, respectively). At 24 months, mean BSCVA was 0.17±0.10 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent, 20/25) in the L-DALK group vs 0.22±0.10 logMAR (Snellen equivalent, 20/32) in the S-DALK group. Differences were observed between the L-DALK group and the S-DALK group in terms of refractive sphere (p=0.015), manifest cylinder (p=0.014) and spherical equivalent refractive error (p=0.034) at any time interval postoperatively. At 24 months, the mean spherical equivalent refractive error was -3.5±3.2 D and -5.2±2.6 D in the L-DALK and S-DALK groups, respectively. CONCLUSIONS: L-DALK can reduce the degree of postoperative myopia and manifest astigmatism and improve visual acuity outcomes in keratoconus compared with S-DALK. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (TRC-13003122). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
BACKGROUND: To investigate the difference in clinical outcomes between large-diameter deep anterior lamellar keratoplasty (L-DALK) and standard DALK (S-DALK) for the treatment of keratoconus. METHODS: 132 patients (132 eyes) from the Zhongshan Ophthalmic Center with a clinical diagnosis of keratoconus were enrolled. The participants were featured by the intolerance to rigid gas-permeable contact lenses or unsuccessful fitting of contact lenses. Using stratified blocked randomisation, eligible eyes were allocated into the L-DALK group or the S-DALK group (66 eyes, respectively). Postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refractive sphere, manifest cylinder and spherical equivalent refractive error were tested at 6, 12, 18 and 24 months after surgery. RESULTS: After surgery, the L-DALK group had better UCVA and BSCVA than the S-DALK group (p=0.000 and 0.021, respectively). At 24 months, mean BSCVA was 0.17±0.10 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent, 20/25) in the L-DALK group vs 0.22±0.10 logMAR (Snellen equivalent, 20/32) in the S-DALK group. Differences were observed between the L-DALK group and the S-DALK group in terms of refractive sphere (p=0.015), manifest cylinder (p=0.014) and spherical equivalent refractive error (p=0.034) at any time interval postoperatively. At 24 months, the mean spherical equivalent refractive error was -3.5±3.2 D and -5.2±2.6 D in the L-DALK and S-DALK groups, respectively. CONCLUSIONS: L-DALK can reduce the degree of postoperative myopia and manifest astigmatism and improve visual acuity outcomes in keratoconus compared with S-DALK. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (TRC-13003122). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
Clinical Trial; Cornea; Treatment Surgery
Authors: L Rico-Del-Viejo; M Garcia-Montero; J L Hernández-Verdejo; S García-Lázaro; F J Gómez-Sanz; A Lorente-Velázquez Journal: J Ophthalmol Date: 2017-12-21 Impact factor: 1.909