Dataset Information

Corneal Densitometry After Small Incision Lenticule Extraction (SMILE) and Femtosecond Laser-Assisted LASIK (FS-LASIK): 5-Year Prospective Comparative Study.

ABSTRACT: Purpose: To investigate long-term changes in corneal densitometry (CD) following small incision lenticule extraction (SMILE) vs. femtosecond laser-assisted LASIK (FS-LASIK) in patients with myopia or myopic astigmatism. Methods: Prospective analysis was performed in 66 eyes of 38 patients (13 males) who underwent SMILE and 54 eyes of 29 patients (5 males) who underwent FS-LASIK. In all patients, an ocular examination was performed preoperatively, and at 6-12 months and 5 years postoperatively. CD was obtained with the Pentacam Scheimpflug imaging system at the 0-2-mm, 2-6-mm, and 6-10-mm zones of the cornea at depth of anterior 120 ?m, midcornea, and posterior 60 ?m. Correlation analysis was performed between postoperative change in CD and other variables such as age, type of surgery, central corneal thickness, spherical equivalent, lenticule thickness/ablation depth, and changes in wavefront aberrations. Results: At postoperative 6-12 months, a significant reduction at several corneal zones in the FS-LASIK cohort (P < 0.05) was observed. In the SMILE cohort, no significant change in CD relative to baseline was observed. However, at 5 years postoperatively, in both groups, a significant decrease in CD was observed in three zones of three layers (all P < 0.001). The change in CD was similar between groups at postoperative 6-12 months, but at 5 years the magnitude of change was significantly smaller in SMILE than FS-LASIK in the anterior and central layers (all P < 0.05). Conclusion: CD with the Scheimpflug imaging system showed a significant decrease at 5 years after SMILE or FS-LASIK, and the change was significantly less pronounced after SMILE.

SUBMITTER: Wei R

PROVIDER: S-EPMC7681246 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Corneal Densitometry After Small Incision Lenticule Extraction (SMILE) and Femtosecond Laser-Assisted LASIK (FS-LASIK): 5-Year Prospective Comparative Study.

Wei Ruoyan R Li Meiyan M Yang Weiming W Shen Yang Y Zhao Yu Y Fu Dan D Shang Jianmin J Zhang Jing J Choi Joanne J Zhou Xingtao X

Frontiers in medicine 20201106

<b>Purpose:</b> To investigate long-term changes in corneal densitometry (CD) following small incision lenticule extraction (SMILE) vs. femtosecond laser-assisted LASIK (FS-LASIK) in patients with myopia or myopic astigmatism. <b>Methods:</b> Prospective analysis was performed in 66 eyes of 38 patients (13 males) who underwent SMILE and 54 eyes of 29 patients (5 males) who underwent FS-LASIK. In all patients, an ocular examination was performed preoperatively, and at 6-12 months and 5 years post ...[more]

PMID: 33240901

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Project description:PurposeThe goal of this study was to compare small incision lenticule extraction (SMILE) with femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for treating myopia.MethodsThe CENTRAL, EMBASE, PubMed databases and a Chinese database (SinoMed) were searched in May of 2016. Twelve studies with 1,076 eyes, which included three randomized controlled trials (RCTs) and nine cohorts, met our inclusion criteria. The overall quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group framework. Data were extracted and analysed at three to six months postoperatively. Primary outcome measures included a loss of one or more lines of best spectacle corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA) of 20/20 or better, mean logMAR UCVA, postoperative mean spherical equivalent (SE) and postoperative refraction within ±1.0 D of the target refraction. Secondary outcome measures included ocular surface disease index (OSDI), tear breakup time (TBUT) and Schirmer's 1 test (S1T) as dry eye parameters, along with corneal sensitivity.ResultsThe overall quality of evidence was considered to be low to very low. Pooled results revealed no significant differences between the two groups with regard to a loss of one or more lines in the BSCVA (OR 1.71; 95% CI: 0.81, 3.63; P = 0.16), UCVA of 20/20 or better (OR 0.71; 95% CI: 0.44, 1.15; P = 0.16), logMAR UCVA (MD 0.00; 95% CI: -0.03, 0.04; P = 0.87), postoperative refractive SE (MD -0.00; 95% CI: -0.05, 0.05; P = 0.97) or postoperative refraction within ±1.0 D of the target refraction (OR 0.78; 95% CI: 0.22, 2.77; P = 0.70) within six months postoperatively. The pooled analysis also indicated that the FS-LASIK group suffered more severely from dry eye symptoms (OSDI; MD -6.68; 95% CI: -11.76, -2.00; P = 0.006) and lower corneal sensitivity (MD 12.40; 95% CI: 10.23, 14.56; P < 0.00001) at six months postoperatively.ConclusionsIn conclusion, both FS-LASIK and SMILE are safe, effective and predictable surgical options for treating myopia. However, dry eye symptoms and loss of corneal sensitivity may occur less frequently after SMILE than after FS-LASIK.

Project description:Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3?months post-operatively.Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21?years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3?months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21?years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3?months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye.This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice.Clinicaltrials.gov NCT01216475.

Project description:AimTo compare postoperative clinical outcomes of high myopia after small-incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK).MethodsFrom March 2018 to July 2020, PubMed, MEDLINE, Embase, the Cochrane Library, and several Chinese databases were comprehensively searched. The studies meeting the criteria were selected and included; the data were extracted by 2 independent authors. The clinical outcome parameters were analyzed with RevMan 5.3.ResultsThis meta-analysis included twelve studies involving 766 patients (1400 eyes: 748 receiving SMILE and 652 receiving FS-LASIK). Pooled results revealed no significant differences in the following outcomes: the logarithm of the mean angle of resolution (logMAR) of postoperative uncorrected distance visual acuity (weighted mean difference (WMD) = -0.01, 95% confidence interval (CI): -0.02 to 0.00, I2 = 0%, P = 0.07 at 1 mo; WMD = -0.00, 95% CI: -0.01 to 0.01, I2 = 0%, P = 0.83 at 3 mo; WMD = -0.00, 95% CI: -0.01 to 0.00, I2 = 32%, P = 0.33 in the long term), and the postoperative mean refractive spherical equivalent (WMD = -0.03, 95% CI: -0.09 to 0.03, I2 = 13%, P = 0.30). However, the SMILE group had significantly better postoperative corrected distance visual acuity (CDVA) than the FS-LASIK group (WMD = -0.04, 95% CI, -0.05 to -0.02, I2 = 0%, P<0.00001). In the long term, postoperative total higher-order aberration (WMD = -0.09, 95% CI: -0.10 to -0.07, I2 = 7%, P<0.00001) and postoperative spherical aberration (WMD = -0.15, 95% CI: -0.19 to -0.11, I2 = 29%, P<0.00001) were lower in the SMILE group than in the FS-LASIK group; a significant difference was also found in postoperative coma (WMD = -0.05, 95% CI: -0.06 to -0.03, I2 = 30%, P<0.00001).ConclusionFor patients with high myopia, both SMILE and FS-LASIK are safe, efficacious and predictable. However, the SMILE group demonstrated advantages over the FS-LASIK group in terms of postoperative CDVA, while SMILE induced less aberration than FS-LASIK. It remains to be seen whether SMILE can provide better visual quality than FS-LASIK; further comparative studies focused on high myopia are necessary.

Project description:PurposeTo quantitatively evaluate outcomes after small incision lenticule extraction (SMILE) combined with allogeneic intrastromal lenticule inlay for hyperopia with astigmatism.MethodsIt's a retrospective cohort study. Twenty-four eyes of 15 patients with more than 0.75 diopters (D) of astigmatism in hyperopic eyes were enrolled in this study. The hyperopic eye with astigmatism was first treated with SMILE to correct astigmatism; then a lenticule was extracted from a donor myopic eye and subsequently implanted into the hyperopic eye with astigmatism. Patients were examined preoperatively and 1 day, 1 week, 1,3 months and 1 year after surgery. The main outcome measures were the uncorrected and corrected distance visual acuity (UDVA and CDVA), uncorrected near visual acuity (UNVA), spherical equivalent (SE), corneal topography, anterior segment optical coherence topography (OCT) and ocular response analyzer (ORA) parameters: corneal hysteresis (CH) and corneal resistance factor (CRF). Repeated-measures analyses of variance (ANOVA) and post hoc tests were used to analyze data of different follow-up visits.ResultsThe mean preoperative cylinder was 1.95±1.04(D). The UDVA (from 0.37±0.23 to 0.09±0.09), UNVA (from 0.49±0.21 to 0.08±0.06), SE (from +7.42±3.12 to -0.75±0.79) and astigmatism (+1.95±1.04 to -0.65±0.63) postoperatively were obviously better than those before surgery. Five eyes (26.3%) gained one line of CDVA, and 3 eyes (15.8%) gained two lines of CDVA one year after surgery compared with preoperative levels. The average corneal curvature was changed from (43.19±4.37) D to (49.19±3.87) D one year after surgery. The anterior segment OCT images of corneas with lenticule inlays at each follow-up visit showed that the implanted lenticule was shaped like a crescent in the corneal stroma. The CH and CRF didn't change significantly after surgery (p = 0.189 and p = 0.107respectively).ConclusionsSMILE combined with intrastromal lenticule inlay can be used to correct high hyperopia with astigmatism with good safety, efficacy and reproducibility.

Dataset Information

Corneal Densitometry After Small Incision Lenticule Extraction (SMILE) and Femtosecond Laser-Assisted LASIK (FS-LASIK): 5-Year Prospective Comparative Study.

Publications

Corneal Densitometry After Small Incision Lenticule Extraction (SMILE) and Femtosecond Laser-Assisted LASIK (FS-LASIK): 5-Year Prospective Comparative Study.

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