scholarly journals Small-incision lenticule extraction for correction of refractive error after 2 years of follow-up

2021 ◽  
Vol 80 (1) ◽  
Author(s):  
Hassenien S. Shuber ◽  
Hussein A. Alhamami ◽  
Salah Z. Alasadi

Background: Small-incision lenticule extraction (SMILE) is a relatively novel refractive procedure introduced to correct myopia and myopic astigmatism using femtosecond technology.Aim: The aim of this study was to prospectively assess the predictability, efficacy and safety of SMILE surgery.Setting: The study took place in Alyamama Vision Refractive Center, Baghdad, Iraq.Methods: In this prospective, non-randomised, single-centre clinical study, all patients with myopia or myopic astigmatism underwent the SMILE procedure performed by one surgeon (H.S.S.) with a targeted post-operative refraction of 0 to −0.5 dioptres (D). The procedure was performed using the VisuMax femtosecond platform. Post-operative data, including slit-lamp examination and measurements of uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), objective and subjective refraction, and intraocular pressure (IOP), were recorded.Results: A total of 141 eyes of 76 patients (51 females and 25 males) were included in the study. The mean preoperative spherical equivalent (SE) (−4.37 D ± 1.65 D) ranged from −2.0 D to −10.25 D after 2 years of follow-up, and the mean post-operative SE (−0.06 D ± 0.18 D) ranged from −0.75 D to 0.63 D. A UCVA of 20/40 or better was noted in 98% of the eyes at the 2-year follow-up. Most of the surgical complications, which were seen in 30 eyes, did not result in permanent visual loss. Corneal abrasion was the most common surgical complication, constituting 10.6% of all complications, followed by adherence of the lenticule to the cap (3.5%).Conclusion: The SMILE procedure is effective with high safety and efficacy, and its complication rate will probably decrease with improvement in the surgeon experience level and refinement of the laser parameters.

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.


2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Sri Ganesh ◽  
Sheetal Brar

Purpose. To study the safety and clinical outcomes of ReLEx SMILE with accelerated cross-linking in individuals with thinner corneas, borderline topography, and higher refractive errors.Methods. Eligible patients first underwent SMILE procedure for correction of myopic refractive error. Following the removal of lenticule, 0.25% riboflavin in saline was injected into the interface and allowed to diffuse for 60 seconds. Finally, eye was exposed to UV-A radiation of 45 mW/cm2for 75 seconds through the cap. Total energy delivered was 3.4 J/cm2.Results. 40 eyes of 20 patients with mean age of 26.75 ± 5.99 years were treated. Mean follow-up was 12 months ± 28.12 days. Mean spherical equivalent (SE) was −5.02 ± 2.06 D preoperatively and −0.24 ± 0.18 D postoperatively. The mean central corneal thickness (CCT) and keratometry changed from 501 ± 25.90 µm to 415 ± 42.26 µm and 45.40 ± 1.40 D to 41.2 ± 2.75 D, respectively. Mean uncorrected visual acuity (UCVA) was 20/25 or better in all eyes. No eyes lost lines of corrected distant visual acuity (CDVA). There were no complications like haze, keratitis, ectasia, or regression.Conclusion. Based on the initial clinical outcome it appears that SMILE Xtra may be a safe and feasible modality to prevent corneal ectasia in susceptible individuals.


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.


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.


2021 ◽  
pp. 112067212110183
Author(s):  
Rinky Agarwal ◽  
Prabhav Puri ◽  
Rahul Kumar Bafna ◽  
Chetan Chetan ◽  
Namrata Sharma

Management of mis-dissected lenticule during Small-incision lenticule extraction (SMILE) is technically challenging and might be experienced more by novice surgeons especially in eyes with low refractive errors and thin lenticules. Presently, we describe a rescue method of inverse centripetal dissection (ICD) to manage mis-dissected lenticules. In this technique, after inadvertent dissection of posterior plane prior to anterior plane, the double-ended SMILE dissector is rotated along its shaft axis clockwise from the left upper margin of the mis-dissected lenticule to form an inversely folded lenticule which is then subsequently dissected centripetally till midline. This is then extracted by performing lenticulorrhexis with a pair of microforceps. We performed this technique in 10 eyes of 10 patients and the lenticule extraction was accomplished successfully in all eyes. At six months follow-up, the uncorrected visual acuity was 20/20 with a clear interface in all eyes. The ICD approach might serve as a useful rescue technique for managing mis-dissected lenticules.


2018 ◽  
Vol 103 (4) ◽  
pp. 565-568 ◽  
Author(s):  
Tian Han ◽  
Ye Xu ◽  
Xiao Han ◽  
Li Zeng ◽  
Jianmin Shang ◽  
...  

AimsTo compare long-term clinical outcomes following small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism correction.MethodsIn this retrospective study, we enrolled a total of 101 patients (101 eyes) who underwent SMILE or FS-LASIK 3 years prior. Measured parameters included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction and corneal wavefront aberrations.ResultsNo significant differences in patient characteristics were found between the two groups. At the 3-year follow-up, UDVA was better than or equal to 20/20 in 90% and 85% (p=0.540) of the eyes; the efficacy indexes were 1.05±0.19 and 1.01±0.21 in the SMILE and FS-LASIK groups, respectively (p=0.352). Safety indexes were 1.19±0.17 and 1.15±0.20 in the SMILE and FS-LASIK groups, respectively (p=0.307). Eighty per cent and 65% of eyes were within ±0.50 D of the attempted spherical equivalent correction after SMILE and FS-LASIK, respectively (p=0.164). Vector analysis revealed no significant differences in astigmatic correction between the two groups (p>0.05). Surgically induced spherical aberration was higher in the FS-LASIK group than in the SMILE group (p<0.001).ConclusionLong-term follow-up analysis suggested that both SMILE and FS-LASIK were safe and equally effective for myopic and astigmatic correction.


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.


2019 ◽  
Vol 12 (9) ◽  
pp. e231233
Author(s):  
Garvit Bhutani ◽  
Somasheila I Murthy ◽  
Jagadesh C Reddy ◽  
Pravin K Vaddavalli

A 35-year-old man presented with decreased vision in his left eye following small incision lenticule extraction (SMILE) surgery. The refractive error after surgery was nearly twice his preoperative refractive error in the left eye. The patient was diagnosed as having a retained lenticule after SMILE surgery, which was folded on itself and was successfully managed by conversion to a flap. Postoperatively, the patient maintained good uncorrected visual acuity and a low refractive error, with the best spectacle corrected acuity of 20/20.


QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
A A Abutaleb ◽  
M G Metwally ◽  
T M Elraggal ◽  
O A Salem

Abstract Purpose This study aimed at comparing femto-LASIK with small incision lenticule extraction (SMILE) as regards the safety, efficacy, accuracy and post-operative complications with special emphasis on the post-operative dry eye, corneal sensation and corneal biomechanics in cases of myopia and myopic astigmatism. Patients and Methods The study was a prospective comparative study that was conducted in a private eye hospital on 60 eyes of 30 patients with myopia or myopic astimgatism. Each patient was fully assessed preoperatively including visual acuity, refraction, tear breakup time, Schirmer test, corneal sensation & Ocular Response Analyzer®. Femto-LASIK was done to 15 patients and SMILE was done to 15 patients. Postoperative visual acuity, refraction, tear breakup time, Schirmer test, corneal sensation at 1 month, 3 months and 6 months and Ocular Response Analyzer® at 6 months were done and data was retrieved and analyzed. Results Cylindrical error was higher in SMILE group at all postoperative points. Tear breakup time was better in SMILE group in 1st month, but no significant difference in later follow ups. Corneal sensation was better in SMILE group in 1 month and 3 months, but this difference disappeared at 6 months. Corneal hysteresis & corneal resistance factor were significantly better in SMILE group. Conclusion Both techniques are safe and efficient. Femto-LASIK is more efficient in correcting cylindrical error. SMILE is better in early postoperative dry eye, corneal sensation and in corneal biomechanics.


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.


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