TY - JOUR
T1 - Laser-assisted in-situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism
AU - Kahuam-López, Nicolás
AU - Navas, Alejandro
AU - Castillo-Salgado, Carlos
AU - Graue-Hernandez, Enrique O.
AU - Jimenez-Corona, Aida
AU - Ibarra, Antonio
N1 - Funding Information:
Cochrane Eyes and Vision (CEV) US Project, supported by grant 1 U01 EY020522, National Eye Institute, National Institutes of Health, USA. National Institute for Health Research (NIHR), UK.
Funding Information:
Four trials reported source of funding. One trial was funded by the IRCCS-Casa Sollievo della Sofferenza Hospital and Institue of Ophthalmology of Catholic University (Buzzonetti 2008), another was funded by the National Institutes of Health, Research to Prevent Blindness, and the Mayo Foundation (Patel_group 2010). Salomão 2009 was supported by US Public Health Service grants from the National Eye Institute, and Research to Prevent Blindness. IntraLase Corp funded one trial (Tran 2005), and the remaining seven trials did not report funding sources.
Funding Information:
* Richard Wormald, Co-ordinating Editor for Cochrane Eyes and Vision (CEV) acknowledges financial support for his CEV research sessions from the Department of Health through the award made by the National Institute for Health Research to Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology for a Specialist Biomedical Research Centre for Ophthalmology.
Funding Information:
We thank Cochrane Eyes and Vision (CEV) and the editorial team for their support, guidance, and comments. We thank the Covidence team for their support. We thank the Cochrane support team for helping us with technical issues. We acknowledge Lori Rosman for developing the search strategy. We thank Jimmy Le, Anupa Shah, Riaz Qureshi, Tianjing Li, Samuel Abariga, and Kristina Lindsley for their great support provided during the review process. We thank our peer reviewers: Vishal Jhanji (University of Pittsburgh), Shameema Sikder (Wilmer Eye Institute), Terry Kungel, and Nancy Fitton (Cochrane Consumer Network). This work was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting.
Funding Information:
Sponsorship source: National Institutes of Health, Bethesda, Maryland (Grant EY 02037; W.M.B.); Research to Prevent Blindness, Inc, New York, NY (S.V.P. as Olga Keith Wiess Special Scholar, and an unrestricted departmental grant); and Mayo Foundation, Rochester, MN
Publisher Copyright:
Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
PY - 2020/4/7
Y1 - 2020/4/7
N2 - Background: Laser-assisted in-situ keratomileusis (LASIK) is a surgical procedure that corrects refractive errors. This technique creates a flap of the outermost parts of the cornea (epithelium, bowman layer, and anterior stroma) to expose the middle part of the cornea (stromal bed) and reshape it with excimer laser using photoablation. The flaps can be created by a mechanical microkeratome or a femtosecond laser. Objectives: To compare the effectiveness and safety of mechanical microkeratome versus femtosecond laser in LASIK for adults with myopia. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 2); Ovid MEDLINE; Embase; PubMed; LILACS; ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions. We searched the reference lists of included trials. We searched the electronic databases on 22 February 2019. Selection criteria: We included randomized controlled trials (RCTs) of LASIK with a mechanical microkeratome compared to a femtosecond laser in people aged 18 years or older with more than 0.5 diopters of myopia or myopic astigmatism. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: We included 16 records from 11 trials enrolling 943 adults (1691 eyes) with spherical or spherocylindrical myopia, who were suitable candidates for LASIK. Five hundred and forty-seven participants (824 eyes) received LASIK with a mechanical microkeratome and 588 participants (867 eyes) with a femtosecond laser. Each trial included between nine and 360 participants. In six trials, the same participants received both interventions. Overall, the trials were at an uncertain risk of bias for most domains. At 12 months, data from one trial (42 eyes) indicates no difference in the mean uncorrected visual acuity (logMAR scale) between LASIK with a mechanical microkeratome and LASIK with a femtosecond laser (mean difference (MD) –0.01, 95% confidence interval (CI) –0.06 to 0.04; low-certainty evidence). Similar findings were observed at 12 months after surgery, regarding participants achieving 0.5 diopters within target refraction (risk ratio (RR) 0.97, 95% CI 0.85 to 1.11; 1 trial, 79 eyes; low-certainty evidence) as well as mean spherical equivalent of the refractive error 12 months after surgery (MD 0.09, 95% CI –0.01 to 0.19; 3 trials, 168 eyes [92 participants]; low-certainty evidence). Based on data from three trials (134 eyes, 66 participants), mechanical microkeratome was associated with lower risk of diffuse lamellar keratitis compared with femtosecond laser (RR 0.27, 95% CI 0.10 to 0.78; low-certainty evidence). Thus, diffuse lamellar keratitis was a more common adverse event with femtosecond laser than with mechanical microkeratome, decreasing from an assumed rate of 209 per 1000 people in the femtosecond laser group to 56 per 1000 people in the mechanical microkeratome group. Data from one trial (183 eyes, 183 participants) indicates that dry eye as an adverse event may be more common with mechanical microkeratome than with femtosecond laser, increasing from an assumed rate of 80 per 1000 people in the femtosecond laser group to 457 per 1000 people in the mechanical microkeratome group (RR 5.74, 95% CI 2.92 to 11.29; low-certainty evidence). There was no evidence of a difference between the two groups for corneal haze (RR 0.33, 95% CI 0.01 to 7.96; 1 trial, 43 eyes) and epithelial ingrowth (RR 1.04, 95% CI 0.11 to 9.42; 2 trials, 102 eyes [50 participants]). The certainty of evidence for both outcomes was very low. Authors' conclusions: Regarding the visual acuity outcomes, there may be no difference between LASIK with mechanical microkeratome and LASIK with femtosecond laser. Dry eye and diffuse lamellar keratitis are likely adverse events with mechanical microkeratome and femtosecond laser, respectively. The evidence is uncertain regarding corneal haze and epithelial ingrowth as adverse events of each intervention. The limited number of outcomes reported in the included trials, some with potentially significant risk of bias, makes it difficult to draw a firm conclusion regarding the effectiveness and safety of the interventions investigated in this review.
AB - Background: Laser-assisted in-situ keratomileusis (LASIK) is a surgical procedure that corrects refractive errors. This technique creates a flap of the outermost parts of the cornea (epithelium, bowman layer, and anterior stroma) to expose the middle part of the cornea (stromal bed) and reshape it with excimer laser using photoablation. The flaps can be created by a mechanical microkeratome or a femtosecond laser. Objectives: To compare the effectiveness and safety of mechanical microkeratome versus femtosecond laser in LASIK for adults with myopia. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 2); Ovid MEDLINE; Embase; PubMed; LILACS; ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions. We searched the reference lists of included trials. We searched the electronic databases on 22 February 2019. Selection criteria: We included randomized controlled trials (RCTs) of LASIK with a mechanical microkeratome compared to a femtosecond laser in people aged 18 years or older with more than 0.5 diopters of myopia or myopic astigmatism. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Main results: We included 16 records from 11 trials enrolling 943 adults (1691 eyes) with spherical or spherocylindrical myopia, who were suitable candidates for LASIK. Five hundred and forty-seven participants (824 eyes) received LASIK with a mechanical microkeratome and 588 participants (867 eyes) with a femtosecond laser. Each trial included between nine and 360 participants. In six trials, the same participants received both interventions. Overall, the trials were at an uncertain risk of bias for most domains. At 12 months, data from one trial (42 eyes) indicates no difference in the mean uncorrected visual acuity (logMAR scale) between LASIK with a mechanical microkeratome and LASIK with a femtosecond laser (mean difference (MD) –0.01, 95% confidence interval (CI) –0.06 to 0.04; low-certainty evidence). Similar findings were observed at 12 months after surgery, regarding participants achieving 0.5 diopters within target refraction (risk ratio (RR) 0.97, 95% CI 0.85 to 1.11; 1 trial, 79 eyes; low-certainty evidence) as well as mean spherical equivalent of the refractive error 12 months after surgery (MD 0.09, 95% CI –0.01 to 0.19; 3 trials, 168 eyes [92 participants]; low-certainty evidence). Based on data from three trials (134 eyes, 66 participants), mechanical microkeratome was associated with lower risk of diffuse lamellar keratitis compared with femtosecond laser (RR 0.27, 95% CI 0.10 to 0.78; low-certainty evidence). Thus, diffuse lamellar keratitis was a more common adverse event with femtosecond laser than with mechanical microkeratome, decreasing from an assumed rate of 209 per 1000 people in the femtosecond laser group to 56 per 1000 people in the mechanical microkeratome group. Data from one trial (183 eyes, 183 participants) indicates that dry eye as an adverse event may be more common with mechanical microkeratome than with femtosecond laser, increasing from an assumed rate of 80 per 1000 people in the femtosecond laser group to 457 per 1000 people in the mechanical microkeratome group (RR 5.74, 95% CI 2.92 to 11.29; low-certainty evidence). There was no evidence of a difference between the two groups for corneal haze (RR 0.33, 95% CI 0.01 to 7.96; 1 trial, 43 eyes) and epithelial ingrowth (RR 1.04, 95% CI 0.11 to 9.42; 2 trials, 102 eyes [50 participants]). The certainty of evidence for both outcomes was very low. Authors' conclusions: Regarding the visual acuity outcomes, there may be no difference between LASIK with mechanical microkeratome and LASIK with femtosecond laser. Dry eye and diffuse lamellar keratitis are likely adverse events with mechanical microkeratome and femtosecond laser, respectively. The evidence is uncertain regarding corneal haze and epithelial ingrowth as adverse events of each intervention. The limited number of outcomes reported in the included trials, some with potentially significant risk of bias, makes it difficult to draw a firm conclusion regarding the effectiveness and safety of the interventions investigated in this review.
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U2 - 10.1002/14651858.CD012946.pub2
DO - 10.1002/14651858.CD012946.pub2
M3 - Review article
C2 - 32255519
AN - SCOPUS:85083023321
SN - 1465-1858
VL - 2020
JO - Cochrane Database of Systematic Reviews
JF - Cochrane Database of Systematic Reviews
IS - 4
M1 - CD012946
ER -