Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2).

PURPOSE: To evaluate the safety and efficacy of lotilaner ophthalmic solution 0.25% compared with vehicle for the treatment of Demodex blepharitis. DESIGN: Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial. PARTICIPANTS: Four hundred twelve patients with Demodex blepharitis were assigned randomly in a 1:1 ratio to receive either lotilaner ophthalmic solution 0.25% (study group) or vehicle without lotilaner (control group). METHODS: Patients with Demodex blepharitis treated at 21 United States clinical sites were assigned either to the study group (n = 203) to receive lotilaner ophthalmic solution 0.25% or to the control group (n = 209) to receive vehicle without lotilaner bilaterally twice daily for 6 weeks. Collarettes and erythema were graded for each eyelid at screening and at all visits after baseline. At screening and on days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash. MAIN OUTCOME MEASURES: Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to 10 collarettes or fewer (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events. RESULTS: At day 43, the study group achieved a statistically significant (P < 0.0001) higher proportion of patients with collarette cure (56.0% vs. 12.5%), clinically meaningful collarette reduction to 10 collarettes or fewer (89.1% vs. 33.0%), mite eradication (51.8% vs. 14.6%), erythema cure (31.1% vs. 9.0%), and composite cure (19.2% vs. 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation, 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable. CONCLUSIONS: Twice-daily treatment with lotilaner ophthalmic solution 0.25% for 6 weeks generally was safe and well tolerated and met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

The effect of femtosecond laser capsulotomy on the development of posterior capsule opacification.

PURPOSE: To evaluate and compare the effects of femtosecond laser-assisted anterior capsulotomy and manual anterior capsulorhexis on posterior capsule opacification (PCO) development. METHODS: Femtosecond laser-assisted anterior capsulotomy was performed in 40 eyes of 40 patients (FS group) and manual anterior capsulorhexis was performed in 39 eyes of 39 patients (CCC group). An AcrySof one-piece hydrophobic acrylic intraocular lens (Alcon Laboratories, Inc., Fort Worth, TX) was implanted in all eyes. The PCO level was measured using Open-Access Systematic Capsule Assessment (OSCA) software 18 to 26 months after surgery. Postoperative intraocular lens position (ie, tilt and decentration) was measured using Scheimpflug images (Pentacam; Oculus Optikgeräte GmbH, Wetzlar, Germany). RESULTS: There was no statistically significant difference in age, axial length, and follow-up time between the two groups (P > .05). Vertical tilt, horizontal and total decentration of intraocular lenses, and PCO proved to be significantly higher in the CCC group (P = .03, .04, .03, and .01, respectively). After adjusting for axial length and follow-up time, manual anterior capsulorhexis was found to be a significant predictor of higher PCO scores in the multivariable regression model (ß: 0.33; 95% CI: 0.01 to 0.65; P = .04). Vertical tilt affected PCO scores after adjusting for axial length and follow-up time (ß: 0.07; 95% CI: 0.01 to 0.12; P = .02). No capsulotomies were performed during follow-up in either group. CONCLUSIONS: Femtosecond laser-assisted anterior capsulotomy proved to be a safe procedure for postoperative PCO rates. Due to better intraocular lens position, femtosecond laser-assisted anterior capsulotomy resulted in slightly decreased PCO scores; however, evaluating its clinical significance requires further studies.

Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%.

OBJECTIVE: The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043). METHODS: Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients self-administered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity. RESULTS: Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P<0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group. CONCLUSIONS: Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.

Analysis of Research Activity Among Ophthalmology Fellows.

PURPOSE: The academic success of ophthalmology fellows may be significantly impacted by their research engagement. Evaluating the research activity of fellows by subspecialty may provide insight into trends useful for prospective applicants. The objective of this study was to assess the research activity of ophthalmology fellows in the year 2023. METHODS: Ophthalmology fellowship programs were compiled using the Association of University Professors of Ophthalmology and the American Society of Ophthalmic Plastic and Reconstructive Surgery websites. Program subspecialties were categorized as: Cornea and External Disease [CED]; Cornea, External Disease, and Refractive Surgery [CEDRS]; Glaucoma; Medical Retina [MR]; Neuro-Ophthalmology [NO]; Oculoplastics; Pediatric Ophthalmology [PO]; Surgical Retina [SR]; Uveitis; and Other. "Other" consisted of Oncology, Pathology, combined Oncology and Pathology fellowships. We identified current fellows using publicly available online information. Programs and fellows that did not have information available were excluded. Total publications, Hirsch index (h-index), and weighted-relative citation ration (w-RCR) were utilized as measures of research output, while total citations and mean-RCR (m-RCR) served as proxies for research impact. Duration of publishing was calculated using the years of the oldest and most recent publications. Statistical analysis was performed using Kruskal-Wallis H tests with an alpha value of .05. RESULTS: A total of 373 fellows from 229 programs met our inclusion criteria. More than half of fellows were men (54.4%), and the most common degree type was MD (93.0%). Across all subspecialties, the median h-index was 3.0 (IQR = 4), m-RCR was .9 (IQR = 1.2) and w-RCR was 3.2 (IQR = 9.8). The median number of publications was six (IQR = 10, with 34 citations (IQR = 110) and 4 years of publishing (IQR = 6). We observed significant differences in h-index (p = .038), total publications (p < .001), and w-RCR (p = .028) by subspecialty. CONCLUSION: We observed significant differences in research output, but no differences in research impact by subspecialty. Overall, Uveitis and Oculoplastics fellows had higher research activity, while Medical Retina and Other fellows had the lowest. This data is pertinent to better understand the landscape of ophthalmology fellowship applications.

Considerations for the Identification and Management of Geographic Atrophy: Recommendations from an Expert Panel.

Newly approved treatments for patients with geographic atrophy are changing the treatment paradigm, highlighting the need for eye care providers (ECPs) to have a set of recommendations on how to best manage GA patients. Here, we outline how to identify various stages of age-related macular degeneration including geographic atrophy (GA) by examining optimal management scenarios implicating various ECPs and reviewing treatment considerations for patients with GA. Early identification of GA will lead to optimal patient outcomes, while a standardized management scenario will reduce clinical burden among ECPs treating patients with GA.

A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery.

Purpose: To evaluate clinical efficacy and patient preference for a dropless treatment regimen compared to conventional topical therapy in patients undergoing cataract surgery. Patients and Methods: In this prospective, contralateral eye study, patients with bilateral cataract were randomized to receive either intracanalicular dexamethasone insert, intracameral phenylephrine 1%/ketorolac 0.3%, and intracameral moxifloxacin (50 µg) (study group) or topical moxifloxacin 0.5%, ketorolac 0.5%, and prednisolone acetate 1.0% QID (control group). The second eye underwent cataract surgery 2 weeks later and was treated with the opposite treatment. All patients were evaluated at Days 1, 7, 14, 28, and 3 months. The primary outcome measure was postoperative ocular pain. Secondary outcomes included summed ocular inflammation score (SOIS; the sum of the mean anterior chamber cells and anterior flare score), the patient preference for medication protocol between the two eyes, and patient out-of-pocket cost of medications. Safety outcome measures included CDVA, intraocular pressure, central retinal thickness (CRT), and the incidence of reported AEs. Results: The proportion of patients with no pain was similar in both groups at all postoperative visits (p>0.05). No statistically significant difference in SOIS score was observed between the two groups at any visit. A strong majority of the patients (94.7%) preferred the study eye's dropless regimen over the control eye's conventional topical therapy regimen. No statistically significant difference in mean intraocular pressure (IOP) was observed at any postoperative visit, except at Week 1. The mean CDVA was also similar in both groups at all postoperative visits (p>0.05). The postoperative mean CRT was comparable between the two groups. Conclusion: A dropless treatment regimen is as effective as topical eyedrop administration. A higher proportion of patients who underwent bilateral cataract surgery preferred the dropless treatment regimen over the patient-administered eye drop regimen.

Clear corneal incision, an important step in modern cataract surgery: a review.

A clear corneal incision (CCI) is the most commonly used entrance site in modern phacoemulsification cataract surgery. Despite some initial concerns about increased endophthalmitis rates through a self-sealing CCI, recent literature suggests that the risk of infection with proper wound construction and all other necessary precautions is minimal. The technique of creating a clear corneal incision has, with recent developments in corneal imaging, undergone critical appraisal leading to a better understanding of incision architecture. Many surgeons operate through smaller incisions, and they have a wide choice of surgical instruments to create their corneal incisions. The aim of this review is to discuss the history and the current status of clear corneal incision creation, the design and materials of surgical blades, and the current trends in manufacturing and sustainability. Although disposable instruments have some advantages and are very popular, recycling, if possible, and avoiding unnecessary plastic waste are important considerations. In any case, the step of CCI is a small one for the surgeon, but a big one for the eye. That is why it has to be done with the utmost precision and in-depth knowledge is important.

Ligneous Conjunctivitis Secondary to Viral Conjunctivitis.

ABSTRACT: Ligneous conjunctivitis is a rare cause of chronic conjunctivitis that may be triggered by ocular insults such as trauma or infections. We present an interesting case of ligneous conjunctivitis caused by a viral infection that responded well to conservative management. Topical cyclosporine and heparin are a good treatment regimen that caused resolution of lesions and prevented recurrences.

Geographic Atrophy Management Consensus (GA-MAC): a Delphi panel study on identification, diagnosis and treatment.

BACKGROUND/AIMS: With a paradigm shift in geographic atrophy (GA) treatments now available, establishing consensus on the identification and diagnosis of the disease along with considerations for management of patients with GA will assist eye care professionals (ECP) in their day-to-day practices, leading to improved patient outcomes. METHODS: A modified Delphi panel process (Geographic Atrophy Management Consensus) consisting of three total surveys and one virtual live meeting held between survey 2 and survey 3. Data were collected from July to October 2022. Participants included expert members of the eye care community that have demonstrated outstanding leadership among peers: a steering committee with three ECPs and a 15-member panel divided between five optometrists, five comprehensive ophthalmologists and five retina specialists. Consensus on statements related to the management of patients with GA was calculated using the RAND/UCLA Appropriateness Method. RESULTS: At the conclusion of the third survey, consensus was reached on 91% of the 77 statements. Critical consensus topics include: (1) optical coherence tomography as the favoured method to diagnose and monitor GA, (2) preferred practice patterns regarding referral of patients to retina specialists and (3) treatment criteria given the advent of emerging therapeutics for GA. CONCLUSIONS: Generating awareness of early signs of disease development, progression and identifying the best tools to evaluate GA establishes ideal management and referral strategies. Given the paradigm shift in GA management driven by approved therapies, coupled with the fact that the disease is progressive resulting in devastating vision loss, these strategies are critical to ensure best overall outcomes.

Argon laser iridoplasty to improve visual function following multifocal intraocular lens implantation.

PURPOSE: To describe the use of argon laser iridoplasty following implantation of a multifocal intraocular lens (IOL) to improve visual function. METHODS: Argon laser spots of 500-mW power, 500-µm spot diameter, and 500-ms duration were placed in the midperipheral iris in the area in which the iris was encroaching on the IOL. RESULTS: Argon laser iridoplasty provided statistically significant improvement in visual function including corrected distance visual acuity (CDVA) and subjective quality of vision in 14 eyes from 11 patients. Mean CDVA improved from 0.24 (20/35 Snellen) to 0.10 (20/25 Snellen) logMAR (P<.0001), and mean subjective quality of vision improved from 2.9 to 7.5 (P<.0001). CONCLUSIONS: Argon laser iridoplasty should be considered in correcting visual problems associated with decentered multifocal IOLs.

Intracameral dexamethasone 9% vs prednisolone acetate 1% in controlling postoperative pain and inflammation in patients undergoing cataract surgery.

PURPOSE: To compare patient preferences of postoperative cataract surgery topical medication use between a 1-drop and a 3-drop regimen. SETTING: Two private cataract surgery centers. DESIGN: Open-label randomized self-controlled prospective study. METHODS: This study included 30 patients (60 eyes) undergoing routine cataract surgery in both eyes. In this contralateral eye study, 1 eye of each patient was randomized to the 1-drop regimen of intracameral delivery of moxifloxacin and dexamethasone suspension and topical bromfenac for 30 days. The other eye, randomized to the 3-drop regimen, received topical moxifloxacin 0.5% 4 times a day for 7 days and bromfenac 0.07% daily for 30 days postoperatively, along with prednisolone acetate 1% 4 times a day for 30 days. Patients reported their preferred regimen 2 weeks after the second surgery with a validated questionnaire. Secondary outcomes included subjective ocular pain, inflammation score, and out-of-pocket cost. Intraocular pressure (IOP) and macular thickness were also measured. RESULTS: Of the 29 patients, 28 (96.6%) significantly more preferred the eye treated with a 1-drop regimen. Self-reported pain, activity interference, and out-of-pocket cost were significantly less in the 1-drop group. Inflammation and 1-day uncorrected distance visual acuity were also significantly better in the 1-drop group. Macular thickness and mean IOP were similar between groups. CONCLUSIONS: Intracameral delivery of steroid and antibiotics was preferred by most of the patients undergoing cataract surgery. These eyes had significantly less pain, inflammation, activity interference, and out-of-pocket cost and significantly better uncorrected distance visual acuity at 1 day postoperatively. IOP and macular thickness were similar between groups.

Pain control and reduction of opioid use associated with intracameral phenylephrine1.0%-ketorolac 0.3% administered during cataract surgery.

PURPOSE: To compare pain and the need for the opioid fentanyl use associated with the administration of phenylephrine 1.0%-ketorolac 0.3% (P/K) with those of epinephrine administration during cataract surgery. SETTING: Ambulatory surgery center. DESIGN: Single-center, prospective, randomized, double-masked, self-controlled trial. METHODS: Patients undergoing bilateral, topical anesthetic cataract surgery were randomized to receive either intracameral P/K or epinephrine in their balanced salt solution for the first eye and the other for the second eye, 2 weeks later. Fentanyl was used to manage intraoperative pain. The primary end point was the need for fentanyl administration intraoperatively. Secondary outcomes included pain measurements; surgery duration; effective phacoemulsification time; pupil size; and complications. RESULTS: 112 eyes of 56 patients were enrolled. Significantly fewer eyes in the P/K group (7 [12.5%]) than in the epinephrine group (19 [33.9%]; P = .013) required intraoperative fentanyl administration. Mean pain scores were lower in the P/K group than those in the control group at all timepoints. For patients with no pain to mild pain (pain scores ≤ 3), 85.7% (n = 48) of the P/K group and 58.9% (n = 33) of the epinephrine group met this benchmark ( P = .003) intraoperatively. The combined outcome, the number of patients not receiving intravenous fentanyl and experiencing no pain to mild pain, was significantly higher in the study (82.1%, n = 46) than in the control group (58.9%, n = 33; P = .013). CONCLUSIONS: P/K administration significantly reduced pain and the need for fentanyl use. Using P/K is a practical way for cataract surgeons to provide better patient care and reduce the need for intraoperative opioids.

Reduction of Artificial Tears and Use of Adjunctive Dry Eye Therapies After Lifitegrast Treatment: Evidence from Clinical and Real-World Studies.

Purpose: To assess the frequency of patients reducing the use of artificial tears (ATs) among patients with dry eye disease (DED) following lifitegrast treatment. Patients and Methods: Two independent analyses were performed using the data from the 1-year, randomized, multicenter, Phase 3 SONATA trial and a noninterventional, real-world evidence (RWE) study conducted in patients with DED who were treated with lifitegrast in the United States and Canada. In SONATA, patients who had used ATs in the lifitegrast and placebo groups were included. The RWE study reviewed patients' electronic medical records, prescribing patterns, and practices of physicians throughout the survey. These data were then used to compare the proportion of patients using ATs in the 6-month pre-index period versus the 12-month post-index period. Results: Of 293 patients (lifitegrast, n=195; placebo, n=98) from SONATA, 107 (lifitegrast, n=64; placebo, n=43) used ATs during the on-therapy period while 186 (lifitegrast, n=131; placebo, n=55) did not. Of those not using ATs, the proportion of patients in the lifitegrast group at any time was higher (~67% [n=131]) versus placebo (~56% [n=55]); this was the case at all study time-points (Days 90, 180, 270, and 360). The RWE study included 600 patient charts (US, n=550; Canada, n=50); 75.5% (n=453) reported AT use. There was ~40% decrease in the proportion of patients using ATs as adjunct DED therapy to lifitegrast in the post-index period (n=273) versus those in the pre-index period (n=453). Conclusion: The findings show that the reliance on AT use can be gradually reduced with lifitegrast treatment, eventually leading to a reduction in disease burden.

Diagnosis and management of postrefractive surgery ectasia.

Postrefractive surgery ectasia is a serious, sight-threatening complication seen after the following procedures: laser in situ keratomileusis, photorefractive keratectomy, small-incision lenticule extraction, radial keratotomy, and/or arcuate keratotomy. Specific risk factors may include age, corneal thickness, degree of refractive error, corneal topographic changes including irregular astigmatism, percent tissue ablation, and residual stromal bed. Biomarkers may be a new option to help indicate who is at greatest risk for ectasia. Visual aids including spectacles or contacts lenses are often required to achieve optimal vision. Collagen crosslinking is the only treatment believed to stop progression of ectasia and prevent keratoplasty. Other surgical options may include topography-guided phototherapeutic keratectomy and intrastromal corneal ring segments. Ultimately, an "ounce of prevention is a pound of cure," so careful preoperative screening and ultimately offering the safest and most effective treatments for patients is arguably the most important job of the refractive surgeon.

Safety and efficacy of nepafenac punctal plug delivery system in controlling postoperative ocular pain and inflammation after cataract surgery.

PURPOSE: To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery. SETTING: Three U.S. clinical sites. DESIGN: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study. METHODS: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively. RESULTS: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group. CONCLUSIONS: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.

Corneal cross-linking versus conventional management for keratoconus: a lifetime economic model.

AIMS: To assess the cost-effectiveness of corneal collagen cross-linking (CXL) versus no CXL for keratoconus in the United States (US). METHODS: A discrete-event microsimulation was developed to assess the cost-effectiveness of corneal cross-linking (CXL, Photrexa + KXL combination product) versus no CXL for patients with keratoconus. The lifetime model was conducted from a US payor perspective. The source for CXL efficacy and safety data was a 12-month randomized, open-label, sham-controlled, multi-center, pivotal trial comparing CXL versus no CXL. Other inputs were sourced from the literature. The primary outcome was the incremental cost per quality-adjusted life year gained. Costs (2019 USD) and effects were discounted 3% annually. The impacts of underlying uncertainty were evaluated by scenario, univariate, and probabilistic analyses. RESULTS: Starting at a mean baseline age of 31 years and considering a mixed population consisting of 80% slow-progressors and 20% fast-progressors, the CXL group was 25.9% less likely to undergo penetrating keratoplasty (PK) and spent 27.9 fewer years in advanced disease stages. CXL was dominant with lower total direct medical costs (-$8,677; $30,994 versus $39,671) and more QALYs (1.88; 21.80 versus 19.93) compared to no CXL. Considering the impact of reduced productivity loss in an exploratory scenario, CXL was associated with a lifetime cost-savings of $43,759 per patient. CXL was cost-effective within 2 years and cost-saving within 4.5 years. LIMITATIONS: Limitations include those that are common to similar pharmacoeconomic models that rely on disparate sources for inputs and extrapolation on short-term outcomes to a long-term analytical horizon. CONCLUSIONS: Keratoconus is a progressive and life-altering disease with substantial clinical, economic, and humanistic consequences. The economic value of cross-linking is maximized when applied earlier in the disease process and/or younger age, and extends to improved work productivity, out-of-pocket costs, and quality of life.

Five-Year Outcomes Prospective Study of Two First-Generation Trabecular Micro-Bypass Stents (iStent®) in Open-Angle Glaucoma.

PURPOSE: To assess 5-year effectiveness and safety of 2 iStent® trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) not controlled on 1 medication. MATERIALS AND METHODS: This prospective, interventional, single-arm, multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 ocular hypotensive medication, and 22-38 mmHg after medication washout. Eyes underwent standalone implantation of 2 iStent devices and were followed through 60 months postoperatively. Efficacy was quantified by mean diurnal IOP and medication usage. Efficacy endpoints included the proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy), and the proportion of eyes with IOP ≤18 mmHg (secondary efficacy) without medication or secondary glaucoma surgery. Safety parameters included visual acuity, cup-to-disc ratio, visual field, and complications and adverse events. RESULTS: Preoperative mean IOP on 1 medication was 20.6 ± 2.0 mmHg and post-washout unmedicated IOP was 24.1 ± 1.4 mmHg (n = 39). At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP (p < .0001). In addition, this 5-year medication-free IOP constituted a 30% decrease versus preoperative IOP on 1 medication (p < .0001). At Month 60, 89.7% (26/29) of eyes achieved the primary efficacy endpoint of ≥20% IOP reduction versus baseline unmedicated IOP, and 86.2% (25/29) of eyes achieved the secondary efficacy endpoint of IOP ≤18 mmHg, without medication or secondary glaucoma surgery. Throughout follow-up, 89.7-91.3% of eyes were on no medications. Favorable safety included no secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5 years postoperative. CONCLUSIONS: This prospective interventional study demonstrates persistent 5-year reductions in IOP and freedom from medications, together with favorable safety, following implantation of 2 first-generation trabecular micro-bypass stents in eyes with OAG on 1 preoperative medication.

The Effect of Lifitegrast on Refractive Accuracy and Symptoms in Dry Eye Patients Undergoing Cataract Surgery.

PURPOSE: To determine the effect of lifitegrast ophthalmic solution 5% on improving the tear film, biometry/keratometry, and refractive accuracy for dry eye patients scheduled for cataract surgery. PATIENTS AND METHODS: Multicenter, prospective, open-label study of 100 eyes of 100 patients undergoing cataract surgery who had a confirmed diagnosis of dry eye. Patients underwent biometry at baseline and again after a 28-day course of lifitegrast 5% BID. Primary outcome was an improvement in the accuracy of preoperative anterior corneal power measurements at predicting postoperative spherical equivalent (SE) pre- and post-lifitegrast treatment. Secondary outcomes included changes in dry eye symptoms and corneal staining. RESULTS: The accuracy of the biometry readings for the achieved refractive SE: within 0.25 D in 47% and 50% of eyes before and after the initial lifitegrast treatment, respectively; within 0.5 D in 71% and 79% of eyes before and after the initial lifitegrast treatment; and within 0.75 D in 81% and 91% of eyes before and after the initial lifitegrast treatment (p < 0.04). CONCLUSION: Lifitegrast 5% significantly improved preoperative corneal surface measurement accuracy in patients with confirmed dry eye who were scheduled for cataract surgery.

One-year visual and astigmatic outcomes of keratoconus patients following sequential crosslinking and topography-guided surface ablation: the TOPOLINK study.

PURPOSE: To evaluate long-term visual and astigmatic outcomes of sequential corneal crosslinking (CXL) followed by topography-guided photorefractive keratectomy (PRK). SETTING: Single-practice outpatient setting. DESIGN: Retrospective case review. METHODS: This is a single-surgeon retrospective case review of eyes with keratoconus undergoing sequential CXL and then topography-guided PRK. Change in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), topographic, refractive, and keratometric astigmatism was analyzed using power vector analyses at baseline, 6 months, and 12 months after topography-guided PRK. Changes in higher-order aberrations (HOAs), posterior astigmatism, spherical equivalent (SE), and central corneal thickness (CCT) were also analyzed. Correlations between age, time between CXL and PRK, sex, manifest SE, CCT, maximum and average keratometric values, and HOAs were evaluated for significance. RESULTS: Of the 62 eyes studied, regardless of refractive treatment, topography-guided PRK following CXL in patients with keratoconus improved CDVA (mean 20/30; 2-line improvement) and UDVA (mean 20/50; 4-line improvement). Over 12 months, visual acuity continued to improve across all eyes treated (P < .001). Overall, there were significant improvements in corneal astigmatism, maximum keratometry, mean keratometry, SE, posterior astigmatism, and total HOAs. No significant correlations were found between age, sex, time elapsed between CXL and PRK, and age at the time of either procedure on final visual acuity. CONCLUSIONS: Results of this study reinforced previous findings that topography-guided PRK in previously cross-linked keratoconus eyes proves to be an efficacious and safe method for improving visual acuity and reducing irregular corneal astigmatism, with continued improvement.

Evaluating Rotational Stability of an Extended Depth of Focus Toric Intraocular Lens Using a Slit Lamp and Image-Based Analysis.

PURPOSE: To evaluate the rotational stability of a toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software. SETTING: Three clinical practices in the USA. DESIGN: Prospective unmasked randomized clinical trial. METHODS: Subjects presenting for routine cataract surgery that were interested in improved near vision received toric EDOF lenses (TECNIS Symfony® Toric) in both eyes. The measures of interest in the current analysis were the change in orientation of the IOL between 1 day, 1 month and 3 months postoperative. Orientation was measured at the microscope on the day of surgery, and with the slit lamp at all other visits. Day 1, 1-month and 3-month images of the lens orientation were captured with a slit lamp camera. Differences in orientation were recorded and analyzed. RESULTS: A total of 150 eyes had IOL orientation data available. Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees. The percentage of lenses exhibiting rotation of ≤5 degrees between any measured time points was 97% or higher. Results were similar, but significantly more variable, when IOL orientation was measured at the slit lamp. CONCLUSION: The toric EDOF lens evaluated here demonstrated rotational stability that exceeded the prior ANSI standard. The best method to determine IOL orientation changes was through image analysis. .