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.

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.

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.

Factors that influence intraocular pressure changes after myopic and hyperopic LASIK and photorefractive keratectomy: a large population study.

PURPOSE: To describe the factors that influence the measured intraocular pressure (IOP) change and to develop a predictive model after myopic and hyperopic LASIK and photorefractive keratectomy (PRK) in a large population. DESIGN: Retrospective, observational case series. PARTICIPANTS: Patients undergoing primary PRK or LASIK with a refractive target of emmetropia between January 1, 2008, and October 5, 2011. METHODS: The Optical Express database was queried for all subjects. Data were extracted on procedure specifics, preoperative central corneal thickness (CCT), IOP (using noncontact tonometry), manifest refraction, average keratometry, age, gender, and postoperative IOP at 1 week, 1 month, and 3 months. A linear mixed methods model was used for data analysis. MAIN OUTCOME MEASURES: Change in IOP from preoperatively to 1 month postoperatively. RESULTS: A total of 174 666 eyes of 91 204 patients were analyzed. Hyperopic corrections experienced a smaller IOP decrease than myopic corrections for both PRK and LASIK (P<0.0001). Patients who underwent LASIK had a 0.94 mmHg (95% confidence interval [CI], 0.89-0.98) greater IOP decrease than patients who underwent PRK (P<0.0001), reflecting the effect of the lamellar flap. The decrease in IOP was linearly related to preoperative manifest spherical equivalent (MSE) for myopic PRK and LASIK (P<0.0001), weakly correlated with preoperative MSE after hyperopic LASIK, and not related to preoperative MSE after hyperopic PRK. The single greatest predictor of IOP change was preoperative IOP across all corrections. By using the available data, a model was constructed to predict postoperative IOP change at 1 month; this was able to explain 42% of the IOP change after myopic LASIK, 34% of the change after myopic PRK, 25% of the change after hyperopic LASIK, and 16% of the change after hyperopic PRK. CONCLUSIONS: Myopic procedures lower measured IOP more than hyperopic procedures; this decrease was proportional to the amount of refractive error corrected. Independent of the refractive correction, the creation of the lamellar LASIK flap decreased measured IOP by 0.94 mmHg. A best-fit model for IOP change was developed that may allow better interpretation of post-laser vision correction IOP values.

Mitomycin-C in corneal surface excimer laser ablation techniques: a report by the American Academy of Ophthalmology.

OBJECTIVE: To review the published literature assessing the efficacy and safety of mitomycin-C (MMC) as an adjunctive treatment in corneal surface excimer laser ablation procedures. METHODS: Literature searches of the PubMed and Cochrane Library databases were last conducted on August 19, 2014, without language or date limitations. The searches retrieved a total of 239 references. Of these, members of the Ophthalmic Technology Assessment Committee Refractive Management/Intervention Panel selected 26 articles that were considered to be of high or medium clinical relevance, and the panel methodologist rated each article according to the strength of evidence. Ten studies were rated as level I evidence, 5 studies were rated as level II evidence, and the remaining 11 studies were rated as level III evidence. RESULTS: The majority of the articles surveyed in this report support the role of MMC as an adjunctive treatment in surface ablation procedures. When MMC is applied in the appropriate concentration and confined to the central cornea, the incidence of post-surface ablation haze is decreased. Although a minority of studies that evaluated endothelial cell density (ECD) reported an MMC-related decrease in ECD, no clinical adverse outcomes were reported. CONCLUSIONS: Over the past 15 years, the use of MMC during surgery in surface ablation has become widespread. There is good evidence of the effectiveness of MMC when used intraoperatively as prophylaxis against haze in higher myopic ablations. Although there are reports of decreased endothelial counts after the administration of MMC during surgery, the clinical significance of this finding remains uncertain, because no adverse outcomes were reported with as much as 5 years of follow-up. Optimal dosage, effectiveness as prophylaxis in lower myopic and hyperopic ablations, and long-term safety, particularly in eyes with reduced corneal endothelial cell counts from prior intraocular surgery, have yet to be established.

Piggyback intraocular lens implantation to correct pseudophakic refractive error after segmental multifocal intraocular lens implantation.

PURPOSE: To evaluate refractive and visual outcomes of secondary piggyback intraocular lens implantation in patients diagnosed as having residual ametropia following segmental multifocal lens implantation. METHODS: Data of 80 pseudophakic eyes with ametropia that underwent Sulcoflex aspheric 653L intraocular lens implantation (Rayner Intraocular Lenses Ltd., East Sussex, United Kingdom) to correct residual refractive error were analyzed. All eyes previously had in-the-bag zonal refractive multifocal intraocular lens implantation (Lentis Mplus MF30, models LS-312 and LS-313; Oculentis GmbH, Berlin, Germany) and required residual refractive error correction. Outcome measurements included uncorrected distance visual acuity, corrected distance visual acuity, uncorrected near visual acuity, distance-corrected near visual acuity, manifest refraction, and complications. One-year data are presented in this study. RESULTS: The mean spherical equivalent ranged from -1.75 to +3.25 diopters (D) preoperatively (mean: +0.58 ± 1.15 D) and reduced to -1.25 to +0.50 D (mean: -0.14 ± 0.28 D; P < .01). Postoperatively, 93.8% of eyes were within ±0.50 D and 98.8% were within ±1.00 D of emmetropia. The mean uncorrected distance visual acuity improved significantly from 0.28 ± 0.16 to 0.01 ± 0.10 logMAR and 78.8% of eyes achieved 6/6 (Snellen 20/20) or better postoperatively. The mean uncorrected near visual acuity changed from 0.43 ± 0.28 to 0.19 ± 0.15 logMAR. There was no significant change in corrected distance visual acuity or distance-corrected near visual acuity. No serious intraoperative or postoperative complications requiring secondary intraocular lens removal occurred. CONCLUSIONS: Sulcoflex lenses proved to be a predictable and safe option for correcting residual refractive error in patients diagnosed as having pseudophakia.

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.].

Photorefractive Keratectomy in Experienced U.S. Naval Aviators: A Prospective Evaluation.

PURPOSE: To report on the prospective evaluation of photorefractive keratectomy (PRK) in experienced ametropic naval aviators that led to the approval of refractive surgery for military pilots. METHODS: This was the first study evaluating refractive surgery in naval aviators. Return to flight status after PRK and clinical outcomes and subjective and objective flight performance were evaluated. RESULTS: A total of 785 U.S. naval aviators were enrolled in the study. Average preoperative refraction was -2.92 ± 1.73 diopters (D) (range: +5.25 to -9.13 D). By 6 months, 85.9% of eyes were within ±0.50 D and 96.4% were within ±1.00 D of emmetropia. 94.4% of eyes achieved 20/20 or better, 74.3% had 20/16 or better, and 45.2% had 20/12.5 or better uncorrected distance visual acuity (UDVA) at 6 months. A total of 78.5% of aviators met return-to-flight criteria by 4 weeks, 83.3% by 8 weeks, and 90.8% by 12 weeks following PRK. All aviators eventually returned to full flight status. Cumulative flight experience included logging more than 48,000 flight hours and 19,500 landings in the 6 months following PRK. Psychometric questionnaire results showed that 78% reported improved ability to detect other aircraft and 92% reported improved ability to land on an aircraft carrier (82% significantly improved) compared to wearing corrective lenses. No one felt their vision was worse in these dynamic environments. All aviators indicated they would undergo the procedure again and would recommend it to a fellow aviator. CONCLUSIONS: This prospective study in U.S. naval aviators determined PRK to be safe and effective in a unique patient population operating in a visually demanding and hazardous environment. The program continues to be enthusiastically supported by aviators and PRK is now allowed in all branches of the military and for National Aeronautics and Space Administration astronauts. [J Refract Surg. 2024;40(6):e371-e380.].

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 1-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 uncorrected near visual acuity (UNVA), and not being satisfied with vision. ORs were assessed for residual sphere -1.00 to +1.00 diopter (D) in quarter-diopter steps, using 0.00 D as a reference. RESULTS: The analysis included 38 828 multifocal and 11 571 monofocal intraocular lenses (IOLs). The residual myopic sphere ≤-0.25 D and hyperopic sphere ≥+0.50 D had a clinically meaningful effect on UDVA. Although monofocal IOLs had an improvement in UNVA with every additional 0.25 D of myopia, the change in ORs with increasing myopia was not significant for multifocal IOLs. The mean improvement in UNVA comparing eyes with 0.00 D and -1.00 D 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 0.25 D of residual myopia, there was >25% increase in dissatisfied patients. CONCLUSIONS: Although 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.

Immediate Sequential Bilateral Cataract Surgery in Patients with Bilateral Visually Significant Cataracts.

Purpose: To report our experience of performing immediate sequential bilateral cataract surgery (ISBCS) in patients with visually significant cataracts and reduced preoperative corrected distance visual acuity (CDVA). Methods: Data of patients who underwent ISBCS for visually significant cataracts and had preoperative CDVA ≤20/32 (≤0.2 logMAR) in each eye were retrospectively reviewed. Refractive and visual outcomes were evaluated for the last available postoperative visit. Intraoperative and serious postoperative adverse events occurring within the first three months of surgery were reviewed. Results: A total of 1335 patients (2670 eyes) were included in the analysis, with a mean age of 71.9 ± 9.5 years. On the last visit, 50.2% and 89.1% of eyes achieved uncorrected distance visual acuity (UDVA) ≥20/20 (0.0 logMAR) and ≥20/32 (0.2 logMAR), respectively. Of all eyes, 83.8% were within ±0.50D, and 96.4% were within ±1.00 D of emmetropia. Ten patients had postoperative bilateral ametropia of more than 1.00D in each eye, but eight of them still achieved binocular UDVA ≥20/40. Intraoperative events occurred in 14 eyes of 13 patients (per-eye incidence: 0.524% or 1 in 191 eyes). A total of 86 postoperative adverse events occurred in 80 eyes of 53 patients (per-eye incidence 2.996% or 1 in 33 eyes), of which cystoid macular edema was the most common. Only three eyes had CDVA reduced by more than two Snellen lines compared to preoperative CDVA, two of which were not related to cataract surgery. There was no patient with bilateral CDVA loss. Conclusion: In our cohort of patients with visually significant cataracts, ISBCS resulted in good refractive predictability and a low incidence of serious adverse events.

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.

The effect of procedure room temperature and humidity on LASIK outcomes.

OBJECTIVE: To determine whether procedure room temperature or humidity during LASIK affect refractive outcomes in a large patient sample. DESIGN: Retrospective cohort study. PARTICIPANTS: A total of 202 394 eyes of 105 712 patients aged 18 to 75 years who underwent LASIK at an Optical Express, Inc., location in their United Kingdom and Ireland centers from January 1, 2008, to June 30, 2011, who met inclusion criteria. METHODS: Patient age, gender, flap creation technique, pre- and 1-month post-LASIK manifest refraction, and ambient temperature and humidity during LASIK were recorded. Effect size determination and univariate and multivariate analyses were performed to characterize the relationships between LASIK procedure room temperature and humidity and postoperative refractive outcome. MAIN OUTCOME MEASURES: One month post-LASIK manifest refraction. RESULTS: No clinically significant effect of procedure room temperature or humidity was found on LASIK refractive outcomes. When considering all eyes in our population, an increase of 1°C during LASIK was associated with a 0.003 diopter (D) more hyperopic refraction 1 month postoperatively, and an increase in 1% humidity was associated with a 0.0004 more myopic refraction. These effect sizes were the same or similar when considering only myopic eyes, only hyperopic eyes, and subgroups of eyes stratified by age and preoperative refractive error. CONCLUSIONS: Neither procedure room temperature nor humidity during LASIK were found to have a clinically significant relationship with postoperative manifest refraction in our population.

Femtosecond lasers for LASIK flap creation: a report by the American Academy of Ophthalmology.

OBJECTIVE: To review the published literature to assess the safety, efficacy, and predictability of femtosecond lasers for the creation of corneal flaps for LASIK; to assess the reported outcomes of LASIK when femtosecond lasers are used to create corneal flaps; and to compare the differences in outcomes between femtosecond lasers and mechanical microkeratomes. METHODS: Literature searches of the PubMed and Cochrane Library databases were last conducted on October 12, 2011, without language or date limitations. The searches retrieved a total of 636 references. Of these, panel members selected 58 articles that they considered to be of high or medium clinical relevance, and the panel methodologist rated each article according to the strength of evidence. Four studies were rated as level I evidence, 14 studies were rated as level II evidence, and the remaining studies were rated as level III evidence. RESULTS: The majority of published studies evaluated a single laser platform. Flap reproducibility varied by device and the generation of the device. Standard deviations in flap thicknesses ranged from 4 to 18.4 µm. Visual acuities and complications reported with LASIK flaps created using femtosecond lasers are within Food and Drug Administration safety and efficacy limits. Of all complications, diffuse lamellar keratitis is the most common after surgery but is generally mild and self-limited. Corneal sensation was reported to normalize by 1 year after surgery. Unique complications of femtosecond lasers included transient light-sensitivity syndrome, rainbow glare, opaque bubble layer, epithelial breakthrough of gas bubbles, and gas bubbles within the anterior chamber. CONCLUSIONS: Available evidence (levels I and II) indicates that femtosecond lasers are efficacious devices for creating LASIK flaps, with accompanying good visual results. Overall, femtosecond lasers were found to be as good as or better than mechanical microkeratomes for creating LASIK flaps. There are unique complications that can occur with femtosecond lasers, and long-term follow-up is needed to evaluate the technology fully.

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.

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.].

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.].

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.