scholarly journals Visual and Refractive Outcomes of Small-Incision Lenticule Extraction in High Myopia: 5-Year Results

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Alper Ağca ◽  
İhsan Çakır ◽  
Beril Tülü Aygün ◽  
Dilek Yaşa ◽  
Yusuf Yıldırım ◽  
...  

Purpose. To report long-term visual and refractive results of small-incision lenticule extraction (SMILE) in treatment of high myopia. Materials and Methods. Medical records of patients who underwent SMILE for surgical correction of myopia or myopic astigmatism were retrospectively reviewed. Only patients with a preoperative spherical equivalent of subjective manifest refraction (SE) ≥ 6 D and a postoperative follow-up of 5 years were included in the study. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and SE were analyzed preoperatively and at 1-, 3-, and 5-year postoperative periods. Results. Thirty-seven eyes of 37 patients were included in the study. The mean attempted SE was −7.47 ± 1.10 D (range −6.00 to −10.00 D). At the 5-year visit, the mean difference between achieved and attempted SE was −0.43 ± 0.47 (0.50 to −1.25 D). Mean postoperative UDVA and CDVA were 0.20 ± 0.18 and 0.06 ± 0.08 logMAR, respectively. At the 1-year visit, 70% and 97% of the eyes were within ±0.50 D and ±1.00 D of the intended correction. At the 5-year follow-up, 59% and 92% percent of the eyes were within ±0.50 D and ±1.00 D of the intended SE, respectively. At the 5-year visit, the efficacy index was 0.89 ± 0.26 and the safety index was 1.16 ± 0.20. Fifty-four percent of the eyes gained one or more lines of CDVA. Conclusion. SMILE with an intended correction of up to a spherical equivalent of 10 D is safe and effective. However, there is regression of the refractive effect over extended follow-up.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Cristina Ariadna Nicula ◽  
Dorin Nicula ◽  
Sorana D. Bolboacă ◽  
Adriana Elena Bulboacă

Abstract Purpose To report the visual and refractive outcomes of small incision lenticule extraction ReLEX (SMILE) technique using VisuMax femtosecond laser in myopia and myopic astigmatism patients. Material and methods A non-randomized clinical study has been conducted on patients with myopia and myopic astigmatism who underwent ReLEX SMILE technique, using the Zeiss VisuMax Laser system (Carl Zeiss Meditec AG, Jena, Germany) at Oculens Clinic, Cluj-Napoca, Romania. Patients older than 18 years, with ocular astigmatism up to -5 diopters (D), spherical equivalent up to -10.00 D, corrected distance visual acuity (CDVA) of 0.3 or better before the surgery, stable refraction for one year, and with a minimum calculated post operator residual stromal bed of 250μ were included in the study. Results The study involved a total of 25 myopic eyes (median of sphere diopters equal with -4D) and 67 myopic astigmatic eyes (median of cylinder diopters equal with -1.5 D). The mean refractive spherical equivalent (MRSE) on patients with myopic eyes reduced from -4.25D (median) to -0.5D at one month follow-up, -0.25 D at 6 and 12 months. The mean refractive spherical equivalent (MRSE) on patients with astigmatic myopic eyes reduced from-6.25 D to -0.67 D at one month, -0.62 D at six and twelve months. The value of sphere decreased postoperatively on myopic eyes with a median of -0.25D at one, six and twelve months. The value of cylinder decreased postoperatively on myopic astigmatic eyes with a median of -0.50 D at one month, -0.25 D at six months and -0.50 D at 12 months. At 6 and 12 months, 20 (80.0%) of myopic eyes were maintained within ±0.5 D and 22 (88.0%) with ±1D. On both groups (myopic eyes and myopic astigmatic eyes), statistically significant differences were observed when the keratometric baseline values were compared to each follow-up (P-values < 0.0001), without any significant differences between follow-ups (P-values>0.15). At 1-month follow-up, uncorrected distance visual acuity (UDVA) was better than or equal to 0.5 in 88.0% of myopic eyes and 82.1% of myopic astigmatic eyes. UDVA remained stable in all cases of myopic eyes at six months and the percentage increased at 92.0% in myopic eyes. UDVA slightly increased at 6-months (85.1%) and remained at the same value at 12-months in myopic astigmatism eyes. Conclusions SMILE proved an effective and safe refractive corneal procedure and provided a predictable and stable correction of myopia and myopic astigmatism. SMILE technique demonstrated very good outcomes in terms of keratometric, cylinder, spherical measurements.


2019 ◽  
Vol 30 (5) ◽  
pp. 917-927
Author(s):  
Suphi Taneri ◽  
Saskia Kießler ◽  
Anika Rost ◽  
Tim Schultz ◽  
H Burkhard Dick

Purpose: Excimer laser-based refractive procedures can have less predictable results when used for correcting high myopia than when used for moderate myopia. Small incision lenticule extraction might overcome this weakness. However, small incision lenticule extraction is only Food and Drug Administration approved for use in myopic eyes up to −8 D with astigmatism of −3 D or less. We report outcomes of small incision lenticule extraction in highly and moderately myopic eyes and compare these to modern laser-assisted in situ keratomileusis. Methods: Retrospective, observational consecutive case series. Inclusion criteria: attempted myopic spherical correction ⩾−8 or−3 to −7.75 D with astigmatism ⩽−3 D, and corrected distance visual acuity of 1.0 (decimal scale) or better. Results: A total of 62 highly myopic and 407 moderately myopic eyes were included. At 3 months postoperatively, the highly myopic eyes had a mean spherical equivalent refraction of −0.28 ± 0.41 D (range: −1.13 to +0.75 D). Mean uncorrected distance visual acuity was 1.0. Mean efficacy index was 0.84. Mean safety index was 1.03. Uncorrected distance visual acuity same or better than corrected distance visual acuity: 61%. Astigmatism was ⩽0.5 D in 90% and ⩽1 D in 100%. The results in the moderately myopic eyes were comparable. Conclusion: We found equally good visual and refractive outcomes after small incision lenticule extraction for the correction of high and of moderate myopia combined with an astigmatic correction of up to 3 D, respectively.


2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Tamer H. Massoud ◽  
Osama Ibrahim ◽  
Kitty Shehata ◽  
Moones F. Abdalla

Purpose. To evaluate the visual and refractive outcomes after small incision lenticule extraction (SMILE) for treating myopia and myopic astigmatism after penetrating keratoplasty (PKP).Design. Case-series.Methods. Ten eyes of 10 patients with previous PKP and residual myopic astigmatism for whom pentacam imaging and thickness measurements were acceptable for laser vision correction. Manifest refraction (MR), uncorrected distance visual acuity (UDVA), and corrected distance visual acuity (CDVA) were obtained preoperatively and one day, one week, and one, 3, and 6 months postoperatively. Cases were operated on the VisuMax® femtosecond laser platform with 500 kHz repetition rate.Results. The mean correction ratio for spherical errors was0.84±0.19 D and for the mean refractive spherical equivalent (MRSE) was0.79±0.13 D. Vector analysis showed a mean astigmatism reduction at the intended axis of67±25.25%, a correction index of0.81±0.21, and an overall mean percentage of success of astigmatism surgery of53±37.9%. The postoperative MRSE was stable throughout the 6-month follow-up period. The efficacy index was 0.93 and the safety index was 1.12.Conclusion. SMILE for correction of post-PKP myopia and astigmatism is effective, safe, and stable with moderate accuracy and predictability. Centration of the treatment within the grafts was easily performed.


2016 ◽  
Vol 27 (2) ◽  
pp. 153-159 ◽  
Author(s):  
Joaquín Fernández ◽  
Almudena Valero ◽  
Javier Martínez ◽  
David P. Piñero ◽  
Manuel Rodríguez-Vallejo

Purpose To determine the safety, efficacy, and predictability of small-incision lenticule extraction at 6-month follow-up, depending on the level of the myopic refractive error. The surgeries were performed by a surgeon new to this technique. Methods Seventy-one subjects with a mean age of 31.86 ± 5.57 years were included in this retrospective observational study. Subjects were divided into 3 groups depending on the preoperative spherical equivalent (SE): low group from -1.00 D to -3.00 D, medium from -3.25 D to -5.00 D, and high from -5.25 D to -7.00 D. Manifest refraction, corrected distance visual acuity (CDVA), and uncorrected distance visual acuity (UDVA) were measured before surgery and at 6 months after the treatment. Results In total, 1.4% of the eyes lost 1 line of CDVA after the procedure, whereas 95.8% remained unchanged and 2.8% gained 1 line. A significant undercorrection (p = 0.031) was found in the high myopia group (median -0.50 D), whereas the low and medium groups remained near to emmetropia. In terms of efficacy, no statistically significant intergroup differences for postoperative UDVA (p = 0.282) were found. The vector analysis also showed undercorrection of the preoperative cylinder, even though the standard deviations decreased from 0.9 D in the x axis and 0.7 D in the y axis to 0.24 D and 0.27 D, respectively. Conclusions Small-incision lenticule extraction might be a safe, effective, and predictable procedure even for inexperienced surgeons. No differences in efficacy were found among myopia levels even though undercorrections were found for SE and cylinder in high myopia.


2019 ◽  
Vol 30 (6) ◽  
pp. 1278-1286 ◽  
Author(s):  
Suphi Taneri ◽  
Saskia Kießler ◽  
Anika Rost ◽  
Tim Schultz ◽  
H Burkhard Dick

Purpose: To compare the visual and refractive outcomes of small incision lenticule extraction and advanced surface ablation for low myopia or myopic astigmatism. Methods: Retrospective, observational case series of our first 50 consecutive small incision lenticule extraction patients compared to refraction-matched 50 advanced surface ablation treatments with attempted spherical equivalent correction ⩽−3.5 D, astigmatism ⩽−1.5 D, and corrected distance visual acuity of 1.0 (decimal scale) or better. Only one eye per patient was included. Results: Small incision lenticule extraction: mean attempted spherical equivalent correction was −2.80 ± 0.63 D. Uncorrected distance visual acuity was 0.85 and 1.0 at days 1 and 5, respectively. At 3 months, mean spherical equivalent refraction was 0.02 ± 0.32 D (range: −0.5 to +0.75 D), mean cylinder was −0.24 ± 0.21 D (range: 0 to −0.75 D), mean uncorrected distance visual acuity was 1.27, mean efficacy index was 0.96, and mean safety index was 1.05. Uncorrected distance visual acuity was same or better than corrected distance visual acuity in 96%, astigmatism ⩽0.5 D in 98% and ⩽1 D in 100% of eyes, respectively. Advanced surface ablation: mean attempted spherical equivalent correction was −2.75 ± 0.5 D. Uncorrected distance visual acuity was 0.72 and 0.61 at days 1 and 5, respectively. At 3 months, mean spherical equivalent refraction was 0.22 ± 0.32 D, mean cylinder was −0.27 ± 0.27 D, mean uncorrected distance visual acuity was 1.21, mean efficacy index was 1.03, and mean safety index was 1.08. Conclusion: Small incision lenticule extraction for low myopia was found to be safe and effective with outcomes at 3 months similar to those obtained with advanced surface ablation while offering a quicker visual recovery.


2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Ihab Mohamed Osman ◽  
Hany Ahmed Helaly ◽  
Mohsen Abou Shousha ◽  
Amir AbouSamra ◽  
Islam Ahmed

Purpose. To assess the safety and stability in cases of small incision lenticule extraction with collagen cross-linking (SMILE Xtra). Methods. This study was a retrospective interventional comparative study that included 60 eyes of 30 patients divided equally into two groups: SMILE Xtra and SMILE alone. The inclusion criteria were patients >18 years of age, myopic error >6 D, thinner cornea <520 microns, and abnormal corneal topography. Outcome data were recorded including uncorrected distance visual acuity and corrected distance visual acuity (UDVA and CDVA), manifest refraction spherical equivalent (MRSE), central corneal thickness, average keratometry, endothelial cell density, corneal resistance factor (CRF), and corneal densitometry. The follow-up period was 24 months. Results. There was a significant difference between the 2 groups regarding UDVA, CDVA, and MRSE at 1 month. In the SMILE Xtra group, 90% of eyes had postoperative UDVA of 20/20 and 97% had UDVA of 20/30 at 24 months. At 24 months, 26 eyes (87%) vs. 25 eyes (84%) were within ±0.50 D of attempted correction in SMILE Xtra and SMILE groups, respectively. Regarding stability, both groups showed improvement of MRSE at 1st month postoperatively and remained stable along the 24 months of follow-up. CRF and corneal densitometry were higher in the SMILE Xtra group along the whole follow-up period (p=0.001). Conclusion. Combining corneal cross-linking with SMILE procedure (SMILE Xtra) is a promising tool to prevent ectasia in high-risk patients. It is a safe and simple procedure that can be offered to patients undergoing SMILE with risk for ectasia. Trial registration no: PACTR201810577524718.


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0242059
Author(s):  
Yanyan Fu ◽  
Yewei Yin ◽  
Xiaoying Wu ◽  
Yuanjun Li ◽  
Aiqun Xiang ◽  
...  

Aim To compare postoperative clinical outcomes of high myopia after small-incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK). Methods From 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. Results This 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). Conclusion For 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.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Amr A. Gab-Alla

Abstract Background To evaluate predictability, stability, efficacy, and safety of transepithelial photorefractive keratectomy (TPRK) using smart pulse technology (SPT) (SmartSurface procedure) of Schwind Amaris with mitomycin C for correction of post small incision lenticule extraction (SMILE) myopic residual refractive errors. Method This study is a prospective, non-comparative case series conducted at a private eye centre in Ismailia, Egypt, on eyes with post-SMILE myopic residual refractive errors because of undercorrection or suction loss (suction loss occurred after the posterior lenticular cut and the creation of side-cuts; redocking was attempted, and the treatment was completed in the same session with the same parameters) with myopia or myopic astigmatism. The patients were followed up post-SMILE for six months before the SmartSurface procedure, and then they were followed up for one year after that. TPRK were performed using Amaris excimer laser at 500 kHz. The main outcomes included refractive predictability, stability, efficacy, safety and any reported complications. Results This study included 68 eyes of 40 patients out of 1920 total eyes (3.5%) with post-SMILE technique myopic residual refractive errors. The average duration between the SMILE surgery and TPRK was 6.7 ± 0.4 months (range 6 to 8 months). The mean refractive spherical equivalent (SE) was within ± 0.50 D of plano correction in 100% of the eyes at 12 months post-TPRK. Astigmatism of < 0.50 D was achieved in 100% of the eyes. The mean of the residual SE error showed statistically significant improvement from preoperative − 1.42 ± 0.52 D to 0.23 ± 0.10 D (P < 0.0001). Uncorrected distance visual acuity (UDVA) (measured by Snellen's chart and averaged in logMAR units) was improved significantly to 0.1 ± 0.07 (P < 0.0001). UDVA was 0.2 logMAR or better in 100% of the eyes, 0.1 logMAR or better in 91.2% of the eyes, and 0.0 logMAR in 20.6% of the eyes. Corrected distance visual acuity (CDVA) remained unchanged in 79.4% of eyes. 14.7% of eyes gained one line of CDVA (Snellen). 5.9% of eyes gained two lines of CDVA (Snellen). Conclusion Transepithelial photorefractive keratectomy using smart pulse technology with mitomycin C enhancement after SMILE is a safe, predictable, stable, and effective technique.


2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Fei Xia ◽  
Yang Shen ◽  
Tian Han ◽  
Jing Zhao ◽  
Haipeng Xu ◽  
...  

Purpose. To investigate the long-term outcomes of refraction, corneal tomography, and wavefront aberrations after small incision lenticule extraction (SMILE) for moderate and high myopia. Methods. Prospective, nonconsecutive case series. A total of 26 patients (26 eyes) who underwent SMILE from May 2010 to March 2013 at the Fudan University Eye and ENT Hospital (Shanghai, China) were enrolled. The periods of follow-up were 1 month, 1 year, 5 years, and 7 years after surgery. The routine eye examinations included uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, and corneal tomography. Results. All surgeries were executed without any complications. At the final visit, an UDVA of 20/20 or better was achieved in 26 eyes (100%) and 11 eyes (42%) exhibited no change in CDVA. 9 eyes (35%) gained one line, 6 eyes (23%) gained two lines, and no eyes lost CDVA. 24 eyes (92%) and 26 eyes (100%) were within ±0.5 D and ±1.00 D of the target refraction, respectively. A mean refractive regression of −0.17 D was observed between 1 month and 7 years postoperatively. Mean corneal front curvature (MCFC) was significantly decreased between pre- and post-SMILE surgery (P<0.0001). Higher-order aberrations (HOAs) and vertical coma were significantly increased after SMILE compared to those measured before surgery (all P<0.001). There were no significant differences in trefoil and spherical aberration between pre- and post-SMILE surgery (all P>0.05). Conclusion. SMILE is an effective, safe, and stable procedure for moderate and high myopia, with relatively constant corneal stability and wavefront aberrations. This trial is registered with ChiCTR-ONRC-13003114.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Nikolaus Luft ◽  
Jakob Siedlecki ◽  
Franziska Reinking ◽  
Wolfgang J. Mayer ◽  
Benedikt Schworm ◽  
...  

AbstractLittle is known about the connection between preoperative keratometry and postoperative results of myopic small-incision lenticule extraction (SMILE). To determine the influence of extreme (flat and steep) corneal keratometry on the safety and efficacy of SMILE, the databases of the Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany, and SMILE Eyes Linz, Austria, were screened for patients with steep and flat keratometry who had undergone SMILE. In this cross-sectional matched comparative cohort study, eyes with markedly flat (< 42.0 diopters; D) or steep (≥ 47.0D) preoperative corneal keratometry were matched to a cohort of eyes with regular keratometry (42.0–46.9D) by preoperative manifest refractive spherical equivalent and cylinder, age, corrected distance visual acuity and surgical SMILE parameters. The standardized graphs and terms for refractive surgery results were applied to compare the three groups. Changes in higher order aberrations (HOAs) were evaluated on Scheimpflug imaging. In total, 63 eyes (21 each) of 54 patients with a mean refractive spherical equivalent of  − 5.21 ± 1.59 D were followed up for a mean of 9.2 ± 6.1 (minimum ≥ 3) months. Mean baseline keratometry was 41.3 ± 0.7D (flat), 45.5 ± 1.0D (regular) and 47.7 ± 0.6D (steep) (p < 0.0001). Compared to the regular group, the flat and the steep cornea group resulted in a non-inferior percentage of eyes within ± 0.50 D of target refraction (p = 0.20), uncorrected distance visual acuity (p = 0.95) and corrected distance visual acuity (p = 0.20). Flat corneas however experienced a stronger induction of spherical aberration (SA) compared to the steep group (p = 0.0005). In conclusion, non-inferior outcomes of SMILE can also be expected in eyes with steep (≥ 47D) or flat (< 42D) preoperative keratometry, while SMILE however induces more SA in eyes with a flat keratometry.


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