Photorefractive Keratectomy and Laser-Assisted In Situ Keratomileusis on 6-Month Space Missions.

BACKGROUND: This article documents the stability of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK) in two astronauts during 6-mo missions to the International Space Station.CASE REPORTS: Ocular examinations including visual acuity, cycloplegic refraction, slit lamp examination, corneal topography, central corneal thickness, optical biometry (axial length/keratometry), applanation tonometry, and dilated fundus examination were performed on each astronaut before and after their missions, and in-flight visual acuity testing was done on flight day 30, 90, and R-30 (30 d before return). They were also questioned regarding visual changes during flight.DISCUSSION: We documented stable vision in both PRK and LASIK astronauts during liftoff, entry into microgravity, 6 mo on the International Space Station, descent, and landing. Our results suggest that both PRK and LASIK are stable and well tolerated during long-duration spaceflight.Gibson CR, Mader TH, Lipsky W, Schallhorn SC, Tarver WJ, Suresh R, Hauge TN, Brunstetter TJ. Photorefractive keratectomy and laser-assisted in situ keratomileusis on 6-month space missions. Aerosp Med Hum Perform. 2024; 95(5):278-281.

Photorefractive Keratectomy in Student Naval Aviators: Outcomes of the U.S. Navy Accessioning Study.

PURPOSE: To present the outcomes of the U.S. Navy photorefractive keratectomy (PRK) accessioning study conducted between 2000 and 2005 that helped lead to the acceptance of laser vision correction within the U.S. aviation industry. METHODS: In this prospective masked study, a total of 301 students who had PRK and underwent naval flight training were compared to 4,368 untreated peers. Three training pipelines were compared: propeller/jet transport, jet fighters, and helicopters. The evaluated metrics were flight and academic performance (assessed for the primary and advanced stage of the training as normalized Navy Standard Score [NSS]), as well as the student attrition rate from training. RESULTS: The attrition rate was lower in the PRK group compared to controls (15.9% vs 23.2%; P = .004). In the primary stage of training, students who had PRK outperformed controls in flight training performance in the propeller/jet transport pipeline (average NSS after PRK: 52.4 ± 7.5 vs controls: 50.7 ± 6.4, P = .02), but the flight performance in the jet fighter and helicopter pipelines was comparable between the two groups. Academic performance in the primary stage of training was approximately 7% to 13% higher in students who had PRK for all training pipelines. During the advanced training stage, there was no difference in the flight performance between the groups in any of the presented pipelines. Academic performance was significantly better for students who had PRK in the helicopter pipeline (51.2 ± 11.0 vs 46.7 ± 11.7 P < .001) but comparable between the two groups in the remaining pipelines. CONCLUSIONS: Refractive surgery did not have adverse effects on flight performance metrics. Pilots who had PRK had comparable or better outcomes than their untreated peers. [J Refract Surg. 2024:40(3):e173-e181.].

Angle Kappa is Not Correlated with Patient-Reported Outcomes After Multifocal Lens Implantation.

Purpose: To examine the effect of preoperative angle kappa on patient-reported outcomes after multifocal lens placement during cataract surgery and determine if it is an effective measure for preoperative patients screening for multifocal lens placement. Setting: Private refractive surgery clinics. Design: Retrospective cohort study. Methods: All patients undergoing bilateral cataract or refractive lens exchange surgery with a target of emmetropia between 2013 and 2017 at Optical Express (Glasgow, UK) with multifocal lens placement for whom preoperative angle kappa measurement and a postoperative month 1 patient-reported outcomes measures were available were included. Results: A total of 1368 patients were identified. Median preoperative angle kappa was 0.41mm with an interquartile range of 0.30mm to 0.53mm. Preoperative angle kappa did not have a significant association with patient-reported satisfaction with vision (correlation coefficient 0.15, 95% confidence interval -0.081 to 0.39, P = 0.20) nor with patient-reported photic phenomena (P > 0.09 for all comparisons). A receiver-operator characteristic analysis did not yield a viable cutoff predictive of patient-reported satisfaction. Conclusion: Angle kappa was not predictive of patient-reported satisfaction in this study. This study did not find evidence that it should be used as a screening test for patients considering multifocal intraocular lens placement.

Effect of residual sphere on uncorrected visual acuity and satisfaction in patients with monofocal and multifocal intraocular lenses.

PURPOSE: To assess the effect of residual sphere on vision and satisfaction in pseudophakic patients. SETTING: Private clinics, United Kingdom. DESIGN: Retrospective case series. METHODS: A multivariate model evaluated the effect of one-month residual sphere on outcomes of pseudophakic patients. Odds ratios (ORs) were calculated to assess the relative risk of not achieving ≥20/20 monocular uncorrected distance visual acuity (UDVA), ≥20/50 near visual acuity (UNVA), and not being satisfied with vision. ORs were assessed for residual sphere -1.00D to +1.00D in quarter-diopter steps, using 0.00D as a reference. RESULTS: The analysis included 38,828 multifocal and 11,571 monofocal IOLs. The residual myopic sphere ≤-0.25D and hyperopic sphere ≥+0.50D had a clinically meaningful effect on UDVA. While monofocal IOLs had an improvement in UNVA with every additional 0.25D of myopia, the change in ORs with increasing myopia was not significant for multifocal IOLs. The mean improvement in UNVA comparing eyes with 0.00D and -1.00D sphere was 0.26 logMAR for monofocal and 0.03 logMAR for multifocal IOLs. Low near-addition IOLs had a slightly higher gain in UNVA with increasing myopia, but the gain was not as substantial as with monofocal IOLs. The effect of ametropia on satisfaction was more pronounced for multifocal IOLs. For every 0.25D of residual myopia, there was >25% increase in dissatisfied patients. CONCLUSIONS: While myopia improved UNVA in eyes with monofocal IOL, multifocal IOLs did not benefit from residual myopia. Multifocal IOL patients desiring distance vision should be targeted closest to emmetropia, even if it means targeting slight hyperopia.

Early Clinical Experience with a New Hydrophobic Acrylic Single-Piece Monofocal Intraocular Lens.

Purpose: To evaluate early clinical outcomes and adverse events (AEs) in cataract patients following implantation of a monofocal hydrophobic acrylic IOL with a new optimized non-constant aberration-correcting design (CT LUCIA 621P). Methods: This retrospective study included patients with visually significant cataracts who underwent implantation of the CT LUCIA 621P IOL. Refraction, corrected (CDVA) and uncorrected (UDVA) visual acuity of the last available visit were used in the analysis. Intraoperative and postoperative AEs of the cohort were reviewed. Results: A total of 191 eyes of 133 patients with the mean age of 70.2±11.2 years were included in this study. The mean follow-up time of the last available visit was 1.7±1.3 months. The mean postoperative monocular UDVA was 0.09±0.16 logMAR (≈20/25), and 74.9% (143/191) eyes achieved ≥20/25 UDVA. The percentage of eyes with manifest spherical equivalent (MSE) within ±0.50D and ±1.00D of emmetropia was 84.8% (162/191) and 98.4% (188/191), respectively. Linear regression of attempted vs achieved MSE showed a tight relationship, with the coefficient of determination close to 1 (R2=0.99), indicating a very predictable refractive correction. The reported AEs were those typically expected after cataract surgery. There were no AEs related to intraoperative manipulation with the IOL/injector or to postoperative stability of the IOL in the capsular bag. No eye lost ≥2 lines of CDVA. Conclusion: The implantation of CT LUCIA 621P resulted in good refractive predictability and visual outcomes. No IOL-related adverse events were reported.

Symptoms and Satisfaction Levels Associated with Intraocular Lens Implants in the Monofocal and Premium IOL Patient-Reported Outcome Measure Study.

PURPOSE: To develop a questionnaire with standardized questions and images about visual symptoms and satisfaction administered before and after cataract surgery with monofocal and various (premium) intraocular lenses (IOLs). DESIGN: A prospective, observational study of cataract surgery patients completing a self-administered questionnaire preoperatively and postoperatively at 4 to 6 months. PARTICIPANTS: Five hundred fifty-four patients with plans to undergo implantation of the same IOL in both eyes on separate occasions in 20 ophthalmology practices. METHODS: An 86-item questionnaire with standardized images assessed the following 14 symptoms: glare, blurry vision, starbursts, hazy vision, snowballs, halos, floaters, double images, rings and spider webs, light flashes with eyes closed, distortion, light flashes with eyes open, shimmering images, and dark crescent-shaped shadows. MAIN OUTCOME MEASURES: Symptom severity and level of symptom bother, satisfaction with vision, quality of vision, and ability to see without corrective lenses or eyeglasses. RESULTS: Except for dark crescent-shaped shadows, the report of visual symptoms significantly decreased postoperatively. Best uncorrected binocular visual acuity improved from 0.47 (20/59 Snellen visual acuity values) ± 0.35 logarithm of the minimum angle of resolution (logMAR) preoperatively to 0.12 (20/26 Snellen visual acuity values) ± 0.12 logMAR postoperatively. Patients' ratings of intermediate vision as good to excellent improved significantly from 12% preoperatively to 71% postoperatively, and patients' ratings of distance vision improved from 8% preoperatively to 85% postoperatively. After surgery, 84% reported that they were somewhat, very, or completely satisfied with their vision. Most patients (88%) reported that they could see pretty well, very well, or perfectly well without corrective lenses after surgery. CONCLUSIONS: The Assessment of IntraOcular Lens Implant Symptoms questionnaire can be used across a wide variety of IOLs to evaluate visual symptoms and satisfaction with a growing segment of the market, premium IOLs, that target intermediate and near vision, in addition to distance vision. Compared to patients receiving monofocal IOLs, patients receiving premium IOLs appear to be more challenging to satisfy because of their requirements for distance, intermediate, and near vision, and their desire to be free of eyeglasses postoperatively. This instrument provides a structured, uniform tool for regulators, researchers, and ophthalmologists in everyday practice to gain insights into patients' experiences. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Immediate Sequential Bilateral Surgery in Refractive Lens Exchange Patients: Clinical Outcomes and Adverse Events.

PURPOSE: To evaluate outcomes and the incidence of adverse events (AEs) in patients who underwent bilateral same-day refractive lens exchange (RLE). DESIGN: Retrospective case series. PARTICIPANTS: Patients of a private intraocular surgery provider in the United Kingdom who underwent RLE in both eyes on the same day with treatment dates between March 2018 and December 2021. METHODS: Clinical outcomes and AEs were collected for a continuous cohort of patients undergoing bilateral same-day RLE (in the absence of visually significant cataracts) or had mild cataracts (corrected visual acuity ≥ 20/40). One-month clinical outcomes were analyzed. MAIN OUTCOME MEASURES: Refractive outcomes and visual acuity, intraoperative and postoperative AEs, and secondary surgical interventions recorded within the first month after surgery. RESULTS: A total of 17 330 patients (34 660 eyes) were included in the analysis. Of these, 28 827 eyes received a multifocal intraocular lens (IOL), and 5833 eyes had a monofocal IOL. The percentage of eyes within ±0.50 diopters (D) of intended refraction was 85.5% and 86.2% for monofocal and multifocal IOL eyes, respectively. There was a total of 55 intraoperative AEs recorded in 55 eyes of 54 patients (per-eye incidence: 0.159%). Posterior capsule tear was the most common intraoperative event occurring in 37 eyes (0.107%). The number of AEs recorded within the first postoperative month was 267, occurring in 263 eyes of 177 patients (per-eye incidence: 0.759%). These included cystoid macular edema (CME) (172 eyes; 0.496%), significant corneal edema (28 eyes; 0.081%), persistent inflammation (27 eyes; 0.078%), significantly raised intraocular pressure (27 eyes; 0.078%), toxic anterior segment syndrome (8 eyes; 0.023%), wound leak (3 eyes; 0.009%), retinal detachment (1 eye; 0.003%), and retinal tear (1 eye; 0.003%). There were 56 secondary surgical interventions recorded within the first month of surgery, occurring in 54 eyes of 47 patients (per-eye incidence: 0.156%). The most common secondary intervention was the rotation of a misaligned toric IOL (24 eyes; 0.069%). CONCLUSIONS: Elective same-day bilateral RLE had a low incidence of serious AEs, and high refractive predictability. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Development of a Patient-Reported Outcome Measure to Assess Symptoms Associated with Cataract Surgery and Intraocular Lens Implants.

PURPOSE: To develop a standardized patient-reported outcome measure of visual perceptions and symptoms for implanted premium and monofocal intraocular lenses (IOLs). DESIGN: Observational study before and after IOL implants to assess the measure and symptom experience. PARTICIPANTS: Adults scheduled for binocular implantation of the same IOL type completed the survey at baseline prior to surgery (n = 716) and postoperatively (n = 554). Most respondents were female (64%), White (81%), 61 or older (89%), and had some college or more education (62%). METHODS: Administration was by web survey with mail follow-up and phone reminders. MAIN OUTCOME MEASURES: Frequency, severity, and level of symptom bother in the last 7 days for 14 symptoms: (1) glare, (2) hazy vision, (3) blurry vision, (4) starbursts, (5) halos, (6) snowballs, (7) floaters, (8) double images, (9) rings and spider webs, (10) distortion, (11) light flashes with eyes closed, (12) light flashes with eyes open, (13) shimmering images, and (14) dark shadows. RESULTS: The median correlation among having 14 symptoms at baseline was only 0.19. Mean uncorrected binocular visual acuity improved from a preoperative value of 0.47 logarithm of the minimum angle of resolution (logMAR; Snellen 20/59) to a postoperative value of 0.12 (20/26) and best-corrected binocular visual acuity improved from 0.23 logMAR (20/34) preoperative to 0.05 logMAR (20/22) postoperative. The most bothersome symptoms were reduced after surgery: preoperative/postoperative glare (84%/36%), blurry vision (68%/22%), starbursts (66%/28%), hazy vision (63%/18%), snowballs (55%/17%), and halos (52%/22%). All symptoms decreased significantly (P < 0.0001) from before to after surgery except for dark crescent-shaped shadows (4%/4%). The percentage of symptoms rated as quite a bit or extremely bothersome declined from before to after surgery except for dark crescent-shaped shadows (29%/32%): blurry vision (54%/15%), snowballs (52%/14%), glare (49%/15%), and halos (46%/14%). Having monofocal IOL implants was associated with significantly more reduction in halos, starbursts, glare, and rings and spider webs, but less improvement in self-reported general vision. CONCLUSIONS: This study provides support for the 37-item Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) instrument for use to assess symptoms and general perceptions of vision in clinical studies and clinical care. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Outcomes of a multicenter U.S. clinical trial of a new monofocal single-piece hydrophobic acrylic IOL.

PURPOSE: To evaluate the safety and effectiveness of the CT LUCIA 611P intraocular lens (IOL) in patients with cataracts. SETTING: 23 surgeons at 15 different clinical sites. DESIGN: Prospective single-arm clinical trial. METHODS: The study was conducted under an Investigational Device Exemption for premarket approval of a new hydrophobic acrylic IOL in the United States. Patients were followed for 12 months, and the main measured variables included uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, and adverse events. RESULTS: In total, 339 eyes of 339 patients were implanted with the study device, of which 310 (91.4%) reached the 12-month visit. The percentage of eyes within ±0.50 diopter (D) and ±1.00 D of emmetropia was 85.8% (266/310) and 96.8% (300/310), respectively. Manifest refraction spherical equivalent (MRSE) remained stable over the first year with the mean 12-month MRSE of -0.03 ± 0.45 D. The mean 12-month UDVA and CDVA were 0.09 ± 0.15 (≈20/25) and -0.02 ± 0.09 (≈20/19) logMAR, respectively. Of all patients, 99.4% (308/310) achieved postoperative CDVA ≥20/40. The incidence of Nd:YAG capsulotomy within the first year was 3.5% (11/310). Only 2 eyes had IOL tilt present at the 12-month postoperative visit with no associated visual symptoms. There were 2 cases of IOL decentration; one required removal of the IOL, whereas the other had no visual side effects related to decentration. There were no findings of glistening at any visit. CONCLUSIONS: The CT LUCIA 611P IOL demonstrated excellent safety, efficacy, and stability of refractive outcomes. No significant issues related to the biocompatibility of the IOL material were observed.

Effect of residual astigmatism on uncorrected visual acuity and patient satisfaction in pseudophakic patients.

PURPOSE: To evaluate the effect of residual astigmatism on postoperative visual acuity and satisfaction after intraocular lens (IOL) surgery. SETTING: Private practice, United Kingdom. DESIGN: Retrospective case series. METHODS: Postoperative data of patients who had previously undergone refractive lens exchange or cataract surgery were used in a multivariate regression model to assess the effect of residual astigmatism on 3 months postoperative monocular uncorrected distance visual acuity (UDVA) and patient satisfaction. The analysis was based on residual refraction in the dominant eye of each patient. Odds ratios were calculated to demonstrate the effect of increasing residual astigmatism on UDVA and satisfaction with separate calculations for monofocal and multifocal IOLs. RESULTS: Three months postoperative outcomes of 17 152 dominant eyes were used in multivariate regression analysis. Compared with eyes with 0.00 diopter (D) residual astigmatism, the odds of not achieving 20/20 vision in eyes with 0.25 to 0.50 D residual astigmatism increased by a factor of 1.7 and 1.9 (P < .0001) in monofocal and multifocal IOLs, respectively. For the residual astigmatism 0.75 to 1.00 D, the odds ratio for not achieving 20/20 vision compared with eyes with no astigmatism was 6.1 for monofocal and 6.5 for multifocal IOLs (P < .0001). The effect of residual astigmatism on satisfaction was more evident at the 0.75 to 1.00 D level, where the odds of not being satisfied with vision increased by a factor of 2.0 and 1.5 in patients with monofocal and multifocal IOLs, respectively (P < .0001). The orientation of astigmatism was not a significant predictor in multivariate analysis. CONCLUSIONS: Multivariate analysis in a large population of patients demonstrated that low levels of residual astigmatism can degrade visual acuity. Corneal astigmatism of 0.50 D or greater should be included in surgical planning.

One-Year Outcomes in a Large Series of Patients Following Implantation of an Extended Depth of Focus Intraocular Lens.

PURPOSE: To evaluate clinical outcomes 1 year after implantation of an extended depth of focus intraocular lens (IOL) in a large series of patients. METHODS: Outcomes of patients who underwent refractive lens exchange or cataract surgery with the implantation of the AT LARA 829MP IOL (Carl Zeiss Meditec AG) were retrospectively reviewed. The near (40 cm), intermediate (66 cm), and distance visual acuity, refractive outcomes, and cumulative rate of adverse events and secondary procedures were evaluated at 12 months postoperatively. RESULTS: A total of 1,894 eyes of 977 patients were implanted with the AT LARA 829MP IOL, with 62.1% of eyes available for the 12-month visit. The overall secondary procedure rate for the whole cohort was: Nd:YAG = 7.8%, laser vision correction = 7.5%, and IOL explantation = 0.63%. The reasons for IOL exchange were intraoperative complications (3 eyes/0.16%) and quality of vision issues (9 eyes/0.48%). Of all eyes available for the 12-month visit that did not undergo laser vision correction or an IOL exchange, 72.0% had monocular uncorrected distance visual acuity of 20/20 or better and the percentage of eyes with monocular uncorrected intermediate and near visual acuity of 20/50 or better was 96.2% and 81.0%, respectively. At 12 months postoperatively, 87.6% of eyes were within ±0.50 diopters of emmetropia. No change in refraction occurred between the 6- and 12-month postoperative visits. CONCLUSIONS: The AT LARA 829MP extended depth of focus IOL is able to provide functional distance, intermediate, and near visual acuity. Complications related to the platform of the IOL were uncommon. [J Refract Surg. 2021;37(6):380-388.].

Impact of Refractive Outcomes on Bias in Follow-up and Completion of Patient-Reported Outcome Measures after Laser Vision Correction.

PURPOSE: To examine factors contributing to completion of a patient-reported outcome (PRO) measure in patients undergoing laser vision correction. DESIGN: Retrospective, population-based study. PARTICIPANTS: All patients who underwent primary laser vision correction with a target of plano from July 1, 2014, to June 30, 2016, at a large refractive surgery center. METHODS: Patients were asked to complete a PRO measure at the time of their preoperative and months 1 and 3 postoperative visits. Characteristics between patients who attended and did not attend the follow-up visits and completed and did not complete the PRO measure were compared. A logistic regression was performed to identify factors associated with likelihood of follow-up and completion of PRO measure. An inverse probability censoring weighted model was created to account for selective loss to follow-up and used to adjust the PRO satisfaction measure. MAIN OUTCOME MEASURE: Completion of the PRO measure at 1 and 3 months. RESULTS: A total of 37 043 patients were identified. Of these, 20 501 completed a 1-month postoperative PRO measure and 10 474 completed a 3-month postoperative PRO measure. Patients completing a PRO measure were more likely to be older, be female, have had photorefractive keratectomy (PRK), have completed a preoperative PRO measure, and have had a preoperative hyperopic correction (P < 0.001 for all comparisons). For every line of postoperative uncorrected acuity worse than 20/16, the odds ratio of completing a PRO measure was 1.33 (95% confidence interval [CI], 1.30-1.36, P < 0.001) at 1 month and 1.29 (95% CI, 1.26-1.33, P < 0.001) at 3 months. At 1 month, there was no difference between the raw and model-adjusted rates of satisfaction with vision, but at 3 months the adjusted rate was significantly higher than the raw rate. CONCLUSIONS: Patients with worse objective visual outcomes were more likely to complete PRO measures in this population-based study. In a setting with loss to follow-up, PRO measures require methods to address missing data for correct interpretation.

Three-Month Outcomes of Laser Vision Correction for Myopia and Hyperopia in Adults With Amblyopia.

PURPOSE: To evaluate the visual outcomes of laser vision correction in adults with myopic and hyperopic amblyopia. METHODS: The medical records of patients diagnosed as having amblyopia who underwent laser refractive surgery between February 2013 and October 2017 were retrospectively reviewed. Eyes with amblyopia were analyzed, and the nonamblyopic fellow eyes of the patients who underwent laser vision correction were used as controls. The uncorrected distance visual acuity (UDVA), subjective manifest refraction, and corrected distance visual acuity (CDVA) were analyzed at the 3-month postoperative time point. RESULTS: This study included 323 eyes of 164 patients. All patients underwent laser in situ keratomileusis (90.1%, 291 eyes) or photorefractive keratectomy (9.9%, 32 eyes). Three months postoperatively, the manifest spherical equivalent was -0.07 ± 0.55 diopters (D) (range: -1.75 to +1.30 D) and -0.10 ± 0.54 D (range: -2.13 to +1.30 D) in the amblyopia group and fellow eye group, respectively. The percentage of eyes achieving UDVA of 20/20 or better was 16.9% (15 eyes) in the amblyopia group and 61.9% (52 eyes) in the fellow eye group. The percentage of eyes that gained two or more lines of CDVA was 27.9% (24 eyes) in the amblyopia group and 6.2% (5 eyes) in the fellow eye group (P < .01). In the amblyopia group, there was no statistically significant difference in the mean manifest spherical equivalent between the myopic eyes and hyper-opic eyes at any follow-up visit (P = .87, 1 month postoperatively; P = .68, 3 months postoperatively). CONCLUSIONS: Laser vision correction was found to be effective and safe in adult patients with amblyopia. [J Refract Surg. 2020;36(8):511-519.].

Predictors of Patient Satisfaction After Refractive Lens Exchange With an Extended Depth of Focus IOL.

PURPOSE: To identify independent factors associated with postoperative satisfaction after refractive lens exchange with an extended depth of focus intraocular lens (EDOF IOL). METHODS: Patients who underwent a refractive lens exchange with bilateral implantation of the AT LARA 829MP IOL (Carl Zeiss Meditec, Jena, Germany) and attended the 3-month follow-up visit were included in the analysis (N = 351 patients). Demographics, preoperative and postoperative clinical parameters, and patient-reported outcomes were used in a regression model to determine predictors of 3-month postoperative satisfaction. RESULTS: The mean age of the study group was 58.2 ± 7.0 years (range: 45 to 79 years) and the mean preoperative sphere ranged between -12.50 and +6.75 diopters (D). At 3 months postoperatively, 86.6% of patients were very satisfied or satisfied with outcomes and 93.2% would recommend the procedure to their family or friends. Of all patients, 90.6% achieved binocular uncorrected distance visual acuity of 20/20 or better, 92.0% achieved binocular near vision of 20/50 or better, and 85.5% of eyes were within ±0.50 D of emmetropia. Logistic regression identified postoperative dry eye symptoms, binocular near and distance visual acuity, and glare symptoms as significant independent factors affecting patient satisfaction. CONCLUSIONS: Several factors were independently predictive of postoperative satisfaction after EDOF IOL implantation and addressing these may further improve patient satisfaction with the procedure, specifically, proper management of early symptoms of dry eye, ensuring good refractive predictability to maximize unaided vision, and counseling patients about the possibility of visual phenomena in the early postoperative period. [J Refract Surg. 2020;36(3):175-184.].

Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial.

PURPOSE: To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism. DESIGN: Prospective, multicenter clinical trial. PARTICIPANTS: The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between -1.00 and -10.00 diopters (D), with manifest spherical equivalent (MSE) of up to -11.50 D and refractive cylinder of up to -3.00 D. METHODS: -Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes. MAIN OUTCOME MEASURES: Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events. RESULTS: Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from -5.39±2.30 D at baseline to -0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from -1.53±0.70 D at baseline to -0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences. CONCLUSIONS: Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.

Outcomes and Adverse Events of Sub-Tenon's Anesthesia with the Use of a Flexible Cannula in 35,850 Refractive Lens Exchange/Cataract Procedures.

PURPOSE: To describe our technique of sub-Tenon's anesthesia and report adverse events and patient comfort. SETTING: Optical Express, United Kingdom. DESIGN: Retrospective case series. METHODS: The outcomes of 35,850 intraocular procedures (phacoemulsification and implantation of an intraocular lens) were retrospectively reviewed and the incidence of adverse events related to sub-Tenon's anesthesia was calculated. On the first postoperative day, patients were asked to complete a questionnaire enquiring about their comfort during and after the procedure. The anesthetic solution consisted of a combination of Lidocaine and Hyaluronidase, which was administered into sub-Tenon's space with a single-use sterile polyurethane 22G x 1" (0.9 x 25 mm) cannula. Mild conscious sedation (midazolam) was used during anesthetic and surgical procedure. RESULTS: No significant adverse events that would affect the posterior segment of the eye or result in vision loss were recorded. Subconjunctival haemorrhage related to sub-Tenon's anesthesia was noted in 4.3% of eyes. Five minutes after the administration of sub-Tenon's block, 80.6% of eyes had no chemosis, 14.8% had chemosis that affected only 1 quadrant of the eye and 4.5% of eyes had chemosis affecting 2 or more quadrants of the eye. Other adverse events included 14 cases of cyst/granuloma formation in the area of sub-Tenon's incision and 7 eyes required suturing of the conjunctival cut. Of all patients, 93.2% experienced no or only mild discomfort during or after surgical procedure. CONCLUSION: Sub-Tenon's anesthesia with the use of a flexible cannula is a safe option for ophthalmic anesthesia. No sight-threatening adverse events occurred.

Incidence of Intraoperative and Early Postoperative Adverse Events in a Large Cohort of Consecutive Laser Vision Correction Treatments.

PURPOSE: To evaluate the incidence of adverse events (AE) following laser vision correction. DESIGN: Retrospective case series. METHODS: Optical Express, UK. Patients/study population: patients who underwent laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) between July 1, 2014, and June 30, 2016. Intervention/observation procedures: all AEs recorded in the electronic medical record were extracted and retrospectively reviewed. The total incidence of AE and serious adverse events (SAE) was calculated. Loss of 2 or more lines of corrected distance visual acuity (CDVA) was calculated for the entire cohort of patients that attended a minimum of 3 months follow-up. MAIN OUTCOME MEASURES: AEs; Preoperative and last available postoperative clinical data. RESULTS: A total of 31,921 (61,833 eyes) were included in the study for LASIK and 5,016 (9,467 eyes) for PRK. The total number of AE was 850 for LASIK (occurring in 783 eyes of 657 patients; incidence of 1.3% or 1:79 eyes) and 227 for PRK (occurring in 218 eyes of 170 patients; incidence of 2.3% or 1:43 eyes). In the LASIK group, there were 287 SAEs (271 eyes of 226 patients; incidence of 0.4% or 1:228 eyes), and the number of SAEs in PRK group was 65 (65 eyes of 39 patients; incidence 0.7% or 1:146 eyes). Combining LASIK and PRK data, the loss of 2 or more lines of CDVA was recorded in 0.37% of eyes. CONCLUSIONS: Contemporary LASIK and PRK are safe procedures with a low incidence of serious adverse events.

SMILE, Topography-Guided LASIK, and Wavefront-Guided LASIK: Review of Clinical Outcomes in Premarket Approval FDA Studies.

PURPOSE: To review clinical outcomes of the U.S. Food and Drug Administration premarket approval (PMA) studies of the three recently approved refractive surgery platforms for the correction of spherocylindrical myopia. METHODS: Clinical outcomes and vector analysis of astigmatism were reviewed and compared between wavefront-guided laser in situ keratomileusis (LASIK) (WFG group) (STAR S4 IR with iDesign aberrometer; Johnson & Johnson Vision Care, Inc., Santa Ana, CA), topography-guided LASIK (TOPO group) (Allegretto Wave Eye-Q laser; Alcon Laboratories, Inc., Fort Worth, TX), and small incision lenticule extraction (SMILE group) (VisuMax laser; Carl Zeiss Meditec AG, Jena, Germany). RESULTS: The number of eyes included was 304, 249, and 334 for the SMILE, TOPO, and WFG groups, respectively. The WFG group had the highest preoperative spherical equivalent refraction (-6.21 ± 2.78 diopters [D]), followed by the SMILE (-5.39 ± 2.30 D) and TOPO (-4.61 ± 2.43 D) groups. At 6 months postoperatively, 83.7%, 88.9%, and 82.6% of eyes in the SMILE, TOPO, and WFG groups, respectively, had uncorrected distance visual acuity (UDVA) of 20/20 or better. SMILE showed slower visual recovery at early postoperative examinations, whereas the WFG group had a decrease in UDVA over time due to refractive regression. The mean refractive cylinder changed from -1.53 ± 0.70 D preoperatively to -0.22 ± 0.33 D at 6 months postoperatively in the SMILE group, -1.19 ± 1.23 to -0.19 ± 0.30 D in the TOPO group, and -1.77 ± 1.65 to -0.33 ± 0.36 D in the WFG group. With all three procedures, undercorrection of refractive cylinder was seen with increasing attempted correction. CONCLUSIONS: All three procedures demonstrated excellent outcomes, considering differences in attempted correction between studies. No obvious superiority of one technique over the others was found in astigmatic correction. [J Refract Surg. 2019;35(11):690-698.].

Incidence of Intraoperative and Early Postoperative Adverse Events in a Large Cohort of Consecutive Refractive Lens Exchange Procedures.

PURPOSE: To evaluate the incidence of adverse events (AEs) in patients who underwent refractive lens exchange. DESIGN: Retrospective case series. METHODS: Setting: Private refractive surgery clinics. Patients/Study Population: Patients who underwent refractive lens exchange between July 1, 2014, and June 30, 2016. Intervention/Observation Procedures: All AEs recorded in the electronic medical record were extracted and retrospectively reviewed. The total incidence of AEs and serious AEs was calculated. Loss of 2 or more lines of corrected distance visual acuity (CDVA) was calculated for the entire cohort of patients that attended a minimum of 3 months follow-up. MAIN OUTCOME MEASURES: AEs. RESULTS: The total number of patients included was 10,206 (18,689 eyes). A multifocal intraocular lens (IOL) was implanted in 84.3% of eyes; 15.7% of eyes received a monofocal IOL. A total of 1164 AEs were recorded (1112 eyes of 1039 patients, incidence 6.0% of eyes, 1:17 eyes). The most common AE was posterior capsular opacification (PCO; 748 eyes, incidence 4.0%). Of all AEs, 171 events (occurring in 165 eyes of 151 patients, incidence 0.9%, 1:113 eyes) were classified as serious, potentially sight threatening. Loss of 2 or more lines of CDVA was 0.56% when excluding eyes where the loss of CDVA was due to PCO; the majority of these were due to macular causes. CONCLUSION: The incidence of sight-threatening AEs and significant loss of CDVA in elective refractive lens exchange surgery was low. Other than PCO, postoperative macular issues were the most common cause of vision loss in this cohort.