Feasibility study of treatment of mixed astigmatism with small-incision lenticule extraction (SMILE) by using research software.

PURPOSE: To report the preliminary experience and initial clinical results following SMILE for the treatment of mixed astigmatism. METHODS: Thirteen eyes of nine patients with a mean age of 27 ± 4.36 years were included in the series. In 8/13 eyes, myopic SMILE license and in 4/13 eyes, hyperopic SMILE license (available as part of an open/research software) was used for the treatment. The mean follow-up was 9.5 ± 8.7 (0.5-24) months, and the median follow-up was 6 months. SETTING: Nethradhama Superspeciality Eye Hospital, Bangalore, India. DESIGN: Exploratory study. RESULTS: The mean preoperative sphere, cylinder, and spherical equivalent (SE) were 1.44 ± 1.63, -2.70 ± 2.30, and -0.24 ± 1.14 D, which changed to -0.03 ± 0.30, -0.28 ± 0.48, and -0.18 ± 0.49 D, respectively, 6 months postoperatively. Furthermore, 85% (11/13) eyes were within ± 0.50 D, 92% (12/13) eyes were within ± 1.00 D, while all eyes were within ± 1.50 D of SE correction. All eyes were within ± 1.00 D of cylinder correction. In addition, 92% (12/13) eyes had UDVA better than 20/32, with 54% (7/13) eyes having UDVA 20/20 or better. Safety and efficacy indices were 1.08 and 0.92, respectively. No eyes lost more than 1 line of CDVA. The mean corneal higher order aberrations (HOA) increased from 0.111 ± 0.048 to 0.209 ± 0.056 (P < 0.001). The mean objective scatter index (OSI) did not show a significant change (pre = 0.71 ± 0.69, 6 months = 0.89 ± 0.20; P = 0.35). CONCLUSION: Early experience showed that SMILE was feasible for the management of eyes with mixed astigmatism, without any intraoperative complications, unique to the procedure.

A prospective, randomized, comparative clinical study to compare the safety and efficacy of different hydrophobic aspheric monofocal intraocular lenses.

Purpose: To report the 1-year clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results with Optiflex Genesis and Eyecryl Plus (ASHFY 600) monofocal aspheric intraocular lenses (IOLs) and compare the same with Tecnis-1 monofocal IOL. Methods: This prospective, single-center, single-surgeon, randomized, three-arm study included 159 eyes of 140 eligible patients who underwent cataract extraction with IOL implantation with any of the three study lenses. Clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results were compared at a mean follow-up of 1 year (12 ± 1.20 months). Results: Preoperatively, age and baseline ocular parameters of all the three groups were matched. At 12 months post-op, no significant differences were noted among the groups in terms of mean postoperative uncorrected and corrected distance visual acuity (UDVA and CDVA, respectively) sphere, cylinder, and spherical equivalent (SE; P > 0.05 for all parameters). Eighty-nine percent eyes in the Optiflex Genesis group as against 96% eyes in the Tecnis-1 and Eyecryl Plus (ASHFY 600) groups were within ± 0.5 D, and 100% of eyes in all the three groups were within ± 1.00 D of SE accuracy. Postoperative internal higher-order aberrations (HOAs) and coma, and mesopic contrast sensitivity at all spatial frequencies were comparable across all the three groups. Two eyes in the Tecnis-1 group, two eyes in the Optiflex group, and one eye in the Eyecryl Plus (ASHFY 600) group underwent YAG capsulotomy at the last follow-up. No eye in any of the groups showed glistenings or required IOL exchange due to any reason. Conclusion: At 1-year post-op, all the three aspheric lenses showed comparable results in visual and refractive parameters, post-op aberrations, contrast sensitivity, and posterior capsule opacification (PCO) behavior. Further follow-up is needed to evaluate the long-term behavior for refractive stability and PCO rates of these lenses. Trial registry: CTRI/2019/08/020754 (www.ctri.nic.in).

Outcomes of bioptics with small-incision lenticule extraction as a sequential treatment after implantable collamer lens for management of extreme myopia.

PURPOSE: To study the safety and efficacy of bioptics using implantable collamer lens (ICL) followed by small-incision lenticule extraction (SMILE) for management of extreme myopia. SETTING: Nethradhama Superspeciality Eye Hospital, Bangalore, India. DESIGN: Retrospective case series. METHODS: Data were analyzed for patients who underwent bioptics using ICL in the first stage and SMILE in the second stage for correction of the residual refractive error. The mean interval between stage 1 and stage 2 correction was 24.2 ± 13.33 days. The mean follow-up after the SMILE procedure was 12.26 ± 1.39 (range 11 to 14) months. RESULTS: Fifteen eyes from 9 patients with mean age 26 ± 4.69 years were included. Preoperatively, the mean SE was -22.89 ± 3.04 diopter (D) (-16.50 to -28.00 D), which decreased to -3.40 ± 1.89 D after ICL and further reduced to -0.48 ± 0.24 D after final correction with SMILE, at the end of the mean follow-up. The mean cylinder reduced from -2.88 ± 1.69 D to -1.93 ± 1.07D post-ICL and to -0.38 ± 0.24 D post-SMILE surgery. The mean corrected distance visual acuity (CDVA) significantly improved from 0.38 ± 0.22 to 0.068 ± 0.09 logMAR after SMILE correction (P = .00). The mean uncorrected distance visual acuity (UDVA) at the end of follow-up was 0.15 ± 0.09 logMAR, with all eyes achieving UDVA of 0.3 logMAR or greater. All eyes had gain in CDVA, with 53% eyes gaining 2 or more lines. No wound-, intraocular pressure-, or ICL-related complications were observed during and after the SMILE surgery. No patient required spectacles, contact lenses, or enhancement for further improvement of vision. CONCLUSIONS: Bioptics with SMILE after ICL implantation might be a valid option for extremely myopic patients, resulting in significant improvements in visual acuity and high patient satisfaction.

Clinical outcomes and rotational stability following implantation of Eyecryl toric intraocular lens - Results of a 12-months prospective study.

Purpose: To evaluate the clinical performance and rotational stability after implantation of Eyecryl Toric monofocal IOL following cataract surgery. Methods: Patients undergoing phacoemulsification for age-related cataract and satisfying the eligibility criteria were implanted with Eyecryl Toric IOL. All implantations were done under balanced salt solution. A marker-less system Callisto Eye (Carl Zeiss Meditec, Germany) was used to guide the intra-operative alignment of the toric IOL. Results: A total of 50 eyes from 39 patients with mean age of 68.2 ± 8.7 years were included in the study. At 12 months, 82% (41) eyes had cumulative UDVA of 20/20 or better. Post-op SE refraction accuracy was within ± 0.50 D for 94% (n = 47) eyes and refractive cylinder accuracy was within ≤0.50 D in 98% (n = 49) eyes. Average post-op rotation at 1 year was 4.06 ± 2.15 degrees. Eighty-four percent of eyes were within 5 degrees and 16% were within 6-10 degrees of intended axis. Two eyes required IOL re-positioning due to significant rotation of the toric IOL (>10 degrees), identified within the 1st week after surgery. Conclusion: Eyecryl toric IOL demonstrated the ability to achieve a significant reduction in astigmatism, improved UDVA outcomes, high levels of spectacle independence, low rates of intra-operative injector related complications and good rotational stability at 12 months post-op.