Corneal stromal lenticule transplantation for the treatment of corneal ulcers.

PURPOSE: To evaluate the safety and efficacy of using corneal stromal lenticules (CSLs) obtained during refractive surgery Refractive Lenticule Extraction (ReLEx) with the Small Incision Lenticule Extraction (SMILE) procedure for the treatment of corneal ulcers. METHODS: This retrospective study included 12 eyes of 12 patients, 7 men and 5 women with varying degrees of corneal ulcer. The mean age was 64 ± 18 (range 34 to 95 years). The monitoring included corrected distance visual acuity (CDVA), slit-lamp biomicroscopy examination, a Seidel test, stability of the graft and anterior segment optical coherence tomography (AS-OCT) inspection. Patients were closely monitored for possible postoperative complications for at least 6 months. RESULTS: In 7/12 (58%) eyes, the corneal ulcer was successfully sealed with CSL and amniotic membrane (AM) without the need for any additional surgical intervention. In 3 eyes, penetrating keratoplasty (PK) was needed in addition to CSL transplantation and in 2 eyes the scleral patch was used to fully seal after CSL transplantation. During the follow-up period no signs of rejection or infection were detected in any patient. CONCLUSION: The use of CSLs from ReLEx SMILE may be considered as an alternative method for the treatment of corneal ulcers before a more extensive and definitive solution - PK - is used. Our preliminary findings suggest that properly performed CSL transplantation using cryopreserved lenticules is a safe and effective method to temporarily cover the corneal partial-thickness defect or even perforation.

Comparative study of small incision refractive lenticule extraction with 5 mm versus 6.5 mm optic zone for myopia.

Purpose: To compare residual stromal thickness (RST) in eyes undergoing small incision refractive lenticule extraction (SMILE) using a lenticular diameter of 6.5 mm versus those with a diameter of 5 mm. Methods: In this retrospective: comparative case series. , consecutive: patients who underwent SMILE between 2016 and 2021 with at least 6 months of follow-up were included. Preoperative best-corrected distance visual acuity (BCDVA), refractive error, contrast sensitivity, central corneal thickness, keratometry, higher order aberrations, and scotopic pupil size were recorded using a Placido disk topography with Sheimpflug tomography-based system. Patients underwent SMILE with a lenticular diameter of 6.5 mm until 2018 (n = 372 eyes). Thereafter, the lenticular diameter was reduced to 5 mm (n = 318). The RST, postoperative refraction, aberrations, subjective glare, and halos were compared across groups at 1 and 6 months. Results: The mean age of participants was 26.8 ± 5.8 years with a mean preoperative spherical equivalent of -4.48 D ± 2.16 D (range: -0.75 to -12.25 D) and mean scotopic pupil of 3.7 ± 0.75 mm. Eyes in the 5 mm group had 30.6 m (95% confidence interval [CI] = 28 to 33 m, P < 0.001) greater RST compared to the 6.5 mm group after adjusting for spherical equivalent and preoperative pachymetry. There were no differences in vision, contrast sensitivity, aberrations (wavefront error of 0.19 ± 0.2 vs. 0.25 ± 0.2, P = 0.19) or glare between the two groups. Conclusion: SMILE performed with a lenticular diameter of 5 mm leads to greater RST across the myopic range, but without inducing significant higher-order aberrations.

A comparison of safety and clinical outcomes of 100 µ versus 160 µ cap in patients undergoing ReLEx-Small Incision Lenticule Extraction (SMILE).

PURPOSE: To determine the safety, efficacy and clinical outcomes of 100 µ versus 160 µ cap in patients undergoing ReLEx-Small Incision Lenticule Extraction (SMILE). METHODS: This prospective, comparative, non-randomized clinical trial included hundred eyes from 50 patients, undergoing bilateral ReLEx SMILE for myopia ranging from - 1 to - 6 D spherical equivalent. Twenty-five patients received treatment with standard 100 µ cap thickness, while the remaining 25 patients underwent the same procedure but with a 160 µ cap thickness in both eyes. Manifest refraction, UDVA, CDVA, contrast sensitivity, aberrations and dry eye were evaluated along with a subjective questionnaire at 2 weeks and 3 months post-operatively. Mean follow-up was 90 ± 15 days. RESULTS: At two weeks and 3 months post-operative, compared to the preoperative values, the mean log-MAR UDVA, CDVA, spherical equivalent, contrast sensitivity higher order aberrations did not show statistically significant differences (p > .05) between the two study groups. However, significant reduction in Schirmer's II and TBUT scores was observed compared to preoperative scores at 3 months in 100 µ group (p > .05) but not in160 µ group. Patients did not report significant subjective complaints in either groups treated, when leading questions were asked through a subjective questionnaire. CONCLUSION: ReLEx SMILE with 160 µ cap thickness was equally safe and efficacious as 100 µ cap, with no unique complications observed by keeping a thicker cap. Post-operative dry eye was significantly less in 160 µ group, suggesting an advantage in patients with pre existing dryness or contact lens users. TRIAL REGISTRATION NUMBER: CTRI/2014/09/005,005.

Quality of life after refractive surgery: ReLEx SMILE vs Femto-LASIK.

PURPOSE: The safety and effectiveness of complex myopic astigmatism correction using ReLEx SMILE or Femto-LASIK techniques have been well established. The purpose of the current study is to compare quality of life (QoL) outcomes following ReLEx SMILE or Femto-LASIK procedures in parallel with functional vision and anatomic outcomes of treated eyes. PATIENTS AND METHODS: This prospective, consecutive series included 118 patients, 18-43 years of age, out of which 56 underwent ReLEx SMILE and 62 underwent Femto-LASIK surgery for correction of myopic astigmatism. All patients underwent standard comprehensive ophthalmic examinations, and additionally, completed The Quality of Life Impact of Refractive Correction Questionnaire to determine the impact the vision-correction treatment had on their QoL. RESULTS: In both treatment groups, the postoperative refractive outcomes were comparable, with visual acuity improvements for both groups noted the day following surgery. After laser correction of complex myopic astigmatism using Femto-LASIK and ReLEx SMILE methods, the overall QoL indicators are statistically significant (P<0.01) exceeding preoperative values 1 month after the operation and reaching the maximum values by the end of the observation period (P<0.0001). CONCLUSION: The results of the study suggest that patients require some time to adapt to their new visual function and its impact on their daily living, delaying detectable improvements in QoL. Moreover, these results may suggest a higher satisfaction trend and long-term QoL in patients undergoing ReLEx SMILE in comparison to Femto-LASIK. Long-term results from the study demonstrated high patient satisfaction with both methods.

Outcomes of Small Incision Lenticule Extraction for Myopic Astigmatic Treatment.

BACKGROUND: Some studies have shown that there is a certain rotation of the eye in the sitting and lying position of the patient. The Visumax system used for the Refractive Lenticule Extraction-Small Incision Lenticule Extraction (ReLEx SMILE) surgery lacks the rotation of eye control function. So, is the ReLEx SMILE surgery for patients with astigmatism safe and effective? AIM: To evaluate the outcomes of the ReLEx SMILE surgery in cases with myopic astigmatism. METHODS: The case series included 120 eyes with myopic astigmatism undergoing ReLEx SMILE surgery from January 2018 to November 2018. The distribution of patients for two subgroups based on the power of astigmatism, low astigmatic group (≤ 1.50D) and high astigmatic group (> 1.50D). All patients were measured UDVA, CDVA, refractive sphere, astigmatism and sphere equivalent before and after surgery one week, one month and three months carefully. The astigmatic correction was evaluated by the vectorial analysis Alpins. RESULTS: The mean efficacy index of the low and high astigmatic group was 1.035 and 1.082 (respectively); the mean safety index was 1.113 and 1.215 (respectively). 93% of eyes in the low astigmatic group had an angle of error (AE) within ± 15 degrees and 100% in high astigmatic group. There was an undercorrection in astigmatic treatment. No complications during and after surgery were recorded. CONCLUSION: ReLEx SMILE surgery for the myopic astigmatic treatment was safe and effective.

Change of tear osmolarity after refractive surgery.

  Purpose: To compare the influence of the LASIK and ReLEx SMILE refractive method on tear osmolarity Methods: Prospective non-randomized comparative study. We evaluated the results in two groups of patients who underwent binocular refractive surgery to remove myopia and possibly astigmatism in the eye clinic of Horní Pocernice. In each group were 15 patients (30 eyes), patients of one group undergoing FS-LASIK refractive surgery, in the second group a ReLEx SMILE procedure. Bilateral measurement of the tear film osmolarity using the TearLab instrument on the day of surgery, the first day after surgery, one month and 3 months after surgery was performed on each patient. Results: The mean preoperative value of the osmolarity of the tear film was practically the same in both groups, in the ReLEx SMILE group 294.9 ± 13.4 mOsm/l and in the FS-LASIK group 296.4 ± 13.1. One and three months after the surgery in the ReLEx SMILE group, these values increased to 301.4 and 296.4 ± 13.3 mOsm/l respectively, the elevation of values one month after surgery was statistically significant. In the FS-LASIK group, one month after surgery, the osmolarity was 320.1 ± 14.7, three months postoperatively 306.5 ± 13.1 mOsm / l. Both of these values compared to the preoperative value were statistically significantly higher. The increase of the mean osmolarity was statistically significantly higher in the FS-LASIK group compared to the ReLEx SMILE. Three months after surgery, the difference between groups was not statistically significant. Conclusion: In our group of patients, after the FS-LASIK refraction procedure, we noted a higher mean osmolarity of tear film in comparison with patients after the ReLEx SMILE in all evaluated timepoints (1 day, 1 month and 3 months after surgery). We consider ReLEx SMILE as a method with less impact on the quality of tear film, with a faster return to original osmolarity and potentially higher patient comfort. Key words: Tear osmolarity, Relex SMILE, FS-LASIK.

[Algorithm for choosing parameters for relex smile surgery]. / Algoritm vybora parametrov pri operatsii ReLEx SMILE.

Presently ReLEx Smile as a method of vision correction in refractive surgery is becoming increasingly popular in Russia and abroad. PURPOSE: to develop an algorithm for planning the surgery and choosing its parameters, and to assess the efficacy, safety and predictability of the results in the 6-month follow-up period. MATERIAL AND METHODS: The study involved 80 patients (159 eyes) with myopia of various degrees with a mean age of 33±6 years (25 to 44 years old). Preoperative BCVA was 0.99±0.04 (0.8 to 1.0), spherical equivalent (SE) was -5.14±1.9 (-10.0 to -1.5). All surgeries were planned and performed according to the developed algorithm. RESULTS: Results were analyzed 6 months postop. The average SE after the surgery was -0.08 D (-0.75 to +0.5). 79.5% of patients (126 eyes) were within ±0.5 D from target refraction, 6% of patients (10 eyes) received 1-2 lines of BCVA, in 87% (138 eyes) BCVA remained unchanged, 6% of patients (10 eyes) lost 1-2 lines of BCVA. 95% of patients (151 eyes) had UCVA of 0.8 and higher 6 month after the surgery, and 79% (125 eyes) achieved 1.0 vision. No significant intraoperative and postoperative complications had occurred. CONCLUSION: ReLEx Smile is an effective, safe and predictable method of myopia correction. The newly developed algorithm reduces the risks of complications. It may be recommended for practical use by surgeons performing ReLEx Smile.

[Visual outcomes four years after small incision lenticule extraction (SMILE) surgery on highly myopic eyes [French version]]. / La prédictibilité du SMILE sur quatre ans chez les myopes forts.

OBJECTIVE: To determine whether the visual outcomes of the refractive surgery technique, small incision lenticule extraction (SMILE), are stable, effective, and predictable for high myopia over a four-year period. RESEARCH DESIGN: This is a retrospective study. The data were collected between March 2012 and July 2016. PARTICIPANTS: Two hundred and forty-eight patients participated in the study; that is, 496 eyes: 140 eyes of 70 patients (52 women/18 men) were classified in the highly myopic group (refraction measured in spherical equivalent [RMSE]>-6D), and 356 eyes of 178 patients (98 women/80 men) in the control group (RMSE≤-6D). Follow-up tests were conducted immediately post-operatively (D+1), after three months, after one year, and after four years. Refraction, uncorrected visual acuity (UCVA), and best visual corrected acuity (BCVA) were measured. The highly myopic group (HMG) contained more women, and astigmatism was higher for this group than for the control group (CG). PRIMARY AND SECONDARY STUDY CRITERIA: These are BCVA, refractive stability, the index of safety (SI: BCVA preoperatively D+1/BCVA postoperatively), and predictability (the percentage of eyes within±0.5 D of the target). RESULTS: In both groups, UCVA was better after the fourth year than it was immediately after the procedure (HMG: P=0.001; CG: P=0.001). Although it differed at one year (P=0.01), the groups' refractive stability tended to converge over four years (P=0.138). Both groups' SI was identical in the four follow-up tests (P=0.734 at D+1; P=0.07 at M+1; P=0.160 at M3 and Y1; and P=0.274 at Y4). For the HMG, SI stability was attained after three months (1.00±0.1); whereas it was attained after one month (0.91±0.11) for the CG. Four years after the surgery, we observed that 87 % of the operated eyes in the HMG were within 0.5 D of the target. CONCLUSION: SMILE is a good refractive surgery technique for treating high myopia. It yields stable, safe, effective, and predictable results over four years.

Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism.

PURPOSE: To compare toric implantable collamer lens (T-ICL), femto-LASIK, and ReLEx SMILE for the treatment of low to moderate myopic astigmatism in terms of long-term visual and refractive outcomes and predictability of astigmatic correction. MATERIALS AND METHODS: The study included 30 eyes from 30 patients between the age groups of 21 and 40 years, undergoing bilateral surgery with any of the three procedures - T-ICL, femto-LASIK, or ReLEx SMILE - for correction of myopic astigmatism within the range of -3 to -8 D spherical equivalent (SE), with a minimum astigmatism of -0.75 D. Patients were followed up at day 1, 1 month, 6 months, and 1 year. RESULTS: At 1 year, the mean cylinder reduced to -0.21±0.28, -0.17±0.36, and -0.22±0.28 D in the T-ICL, femto-LASIK, and ReLEx SMILE group, respectively. The predictability of astigmatism correction was comparable, with no statistically significant difference between the 3 groups (P>0.05). A total of 97% of eyes in ReLEx SMILE achieved a uncorrected distance visual acuity of 20/20 or better, compared to T-ICL (93%) and FS-LASIK (90%). However, gain in lines of corrected distant visual acuity (CDVA) was maximum in T-ICL group (60%). Four eyes in the femto-LASIK group had loss of CDVA by one line. Three eyes required exchange due to high vault and rotation of the T-ICL, which did not affect the final outcome. CONCLUSION: All 3 modalities were effective for myopic astigmatism at the end of 1 year. Quality of vision and patient satisfaction with T-ICL and ReLEx SMILE were similar and better than FS-LASIK. However, slight chances of postoperative rotation and exchange exist with T-ICL, which warrant thorough preoperative planning.

Posterior corneal curvature changes following Refractive Small Incision Lenticule Extraction.

PURPOSE: To compare the posterior corneal curvature changes, in terms of corneal power and asphercity, following Refractive Small Incision Lenticule Extraction (ReLEx SMILE) procedure for low, moderate, and high myopia. METHODS: This retrospective, non randomized, comparative, interventional trial; included 52 eyes of 26 patients, divided in three groups: low myopia (myopia ≤3 D [diopters] spherical equivalent [SE]), moderate myopia (myopia >3 D and <6 D SE), and high myopia (myopia ≥6 D SE). All patients were treated for myopia and myopic astigmatism using ReLEx SMILE. The eyes were examined pre-operatively and 3 months post-operatively using SCHWIND SIRIUS, a three-dimensional rotating Scheimpflug camera with a Placido disc topographer to assess corneal changes with regard to keratometric power and asphericity of the cornea. RESULTS: A statistically significant increase in mean keratometric power in the 3, 5, and 7 mm zones of the posterior corneal surface compared with its pre-ReLEx SMILE value was detected after 3 months in the moderate myopia group (pre-operative [pre-op] -6.14±0.23, post-operative [post-op] -6.29±0.22, P<0.001) and high myopia group (pre-op -6.19±0.16, post-op -6.4±0.18, P<0.001), but there was no significant change in keratometric power of the posterior surface in the low myopia group (pre-op -5.87±0.17, post-op -6.06±0.29, P=0.143). Asphericity (Q-value) of the posterior surface changed significantly (P<0.001) after ReLEx SMILE in the moderate myopia group in the 3, 5, and 7 mm zones, and in the high myopia group in the 3 and 7 mm zones; but there was no significant change in the Q-value in the low myopia group in all three zones (pre-op 0.23±0.43, post-op -0.40±0.71, P=0.170), and in the high myopia group in the 5 mm zone (P=0.228). CONCLUSION: ReLEx SMILE causes significant changes in posterior corneal keratometric power and asphericity in moderate and high myopia, but the effect is subtle and insignificant in low myopia.

[SMILE: refractive lenticule extraction for myopic correction]. / SMILE : correction de la myopie par ablation réfractive par laser femtoseconde d'un lenticule intracornéen.

PURPOSE: It is currently possible to obtain refractive correction without using an excimer laser; the technique is called ReLEx(®) (Refractive Lenticule extraction) and uses the femtosecond laser VisuMax(®) (Carl Zeiss Meditec, Jena, Germany). We present initial clinical experience with small-incision (4mm) lenticule extraction (SMILE) for the treatment of moderate to high myopia via a retrospective study of 106 myopic and astigmatic eyes. MATERIALS AND METHODS: This retrospective study of 106 eyes measures postoperative visual acuity to determine the safety, efficacy and predictability of the technique. For SMILE, an intrastromal lenticule is cut with the VisuMax(®) femtosecond laser; it is then dissected and detached from the anterior and posterior stromal planes and finally removed through a 4mm incision. This procedure does not require the creation of a flap. The study is based on 106 eyes of 54 patients who underwent the surgery for moderate to high myopia, with or without associated astigmatism. Patient selection was the same as for LASIK. RESULTS: The average age of the patients was 33 ± 9 (20-54). The mean preoperative spherical equivalent was -6.22 ± 1.6 (-3; -9.75 D). The mean preoperative sphere was -5.88 D ± 1.52 (-3; -9.75 D) with a mean cylinder of -0.68 D ± 0.58 (0.00; -2.25). Postoperatively, 95% of patients had distance vision greater than or equal to 8/10. No loss of BCVA was noted. The mean postoperative spherical equivalent was -0.16 ± 0.35 D (-1.38; +0.88) with a mean sphere of 0.00 ± 0.34 D (-1,25; +1) and a mean cylinder of -0.31 ± 0.37 D (0; -1.5). One eye was converted to PRK because the incision site was covered by conjunctiva during the last 5 seconds of the laser phase. CONCLUSION: SMILE is a predictable and safe technique for the surgical correction of moderate to high myopia.