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Thomas Kohnen,1 Ruth Lapid-Gortzak,2 Dandapani Ramamurthy,3 Hiroko Bissen-Miyajima,4 Andrew Maxwell,5 Tae-Im Kim,6 Satish Modi7 1Department of Ophthalmology, Goethe-University, Frankfurt, Germany; 2Department of Ophthalmology, Amsterdam University Medical Centers, Amsterdam, Netherlands; 3The Eye Foundation, Coimbatore, Tamil Nadu, India; 4Department of Ophthalmology, Tokyo Dental College Suidobashi Hospital, Tokyo, Japan; 5The California Eye Institute, Fresno, CA, USA; 6Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea; 7Seeta Eye Centers, Poughkeepsie, NY, USACorrespondence: Thomas Kohnen, Department of Ophthalmology, Goethe University, Theodor‑Stern-Kai 7, Frankfurt, 60590, Germany, Tel +49 69 6301 6739/ 3945, Fax +49 69 6301 3893, Email thomas.Kohnen@kgu.dePurpose: To investigate visual and safety outcomes of AcrySof® IQ PanOptix® (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies.Patients and Methods: This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies’ design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4– 5 m), intermediate (UCIVA, DCIVA; 60– 66 cm), and near (UCNVA, DCNVA; 40 cm) were measured.Results: The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3– 6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4– 5 m) to near (– 3.00D; optically equivalent to 33 cm) was observed 3– 6 months after TFNT00 implantation. At 3– 6 months, 88.2% of first eyes achieved an MRSE ≤ 0.50 D and 88.7% of second eyes achieved an MRSE ≤ 0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent.Conclusion: This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs.Keywords: PanOptix, intraocular lens, presbyopia, trifocal lens, diffractive lens, pooled analysis

Gina Wesley,1 Katherine Bickle,2 Johnathon Downing,3 Bret Fisher,4 Brennan Greene,5 Colton Heinrich,6 David Kading,7 Shane Kannarr,8 Jason Miller,9 Satish Modi,10 David Ludwick,11 Joseph Tauber,12 Thao N Yeh,13 Sruthi Srinivasan14 1Complete Eye Care of Medina, Hamel, MN, USA; 2ProCare Vision Center, Granville, OH, USA; 3East West Eye Institute, Los Angeles, CA, USA; 4Eye Center of N Florida, Panama City, FL, USA; 5The Eye Care Institute, Louisville, KY, USA; 6Clarke EyeCare Center, Wichita Falls, TX, USA; 7Specialty Eyecare Group, Bellevue, WA, USA; 8Kannarr Eye Care LLC, Pittsburg, KS, USA; 9Insight Research Clinic, Powell, OH, USA; 10Alterman, Modi & Wolter, Poughkeepsie, NY, USA; 11Ludwick Eye Center, Chambersburg, PA, USA; 12Tauber Eye Center, Kansas City, MO, USA; 13Alcon Vision, LLC, Fort Worth, TX, USA; 14Alcon Research, LLC, Johns Creek, GA, USACorrespondence: Sruthi Srinivasan, Alcon Research, LLC, 11460 Johns Creek Parkway, Johns Creek, GA, 30097, USA, Tel +1 678 415 5315, Email sruthi.srinivasan@alcon.comPurpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment.Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤ 12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score > 16, and non-invasive tear break-up time (NITBUT) < 10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux.Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4± 13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9± 3.69; month 12: 22.8± 11.31; change: 15.9± 11.57, p< 0.0001]; OS [baseline: 6.4± 3.66; month 12: 23.0± 11.33; change: 16.7± 11.40, p< 0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2± 1.97; month 12: 7.0± 3.68; change: 1.9± 3.69, p< 0.0001]; OS [baseline: 5.6± 1.96; month 12: 7.9± 4.58; change: 2.3± 4.59, p< 0.0001]) and IDEEL-SB score (p< 0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1± 2.96; month 12: 0.7± 1.56; change: − 1.4± 2.65, p< 0.0001]; OS [baseline: 2.1± 2.94; month 12: 0.7± 1.44; change: − 1.4± 2.75, p< 0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p< 0.001).Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.Keywords: corneal staining, meibomian gland dysfunction, meibomian gland score, tear break-up time

Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months.This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye.In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes.A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference,-5), NITBUT (-2.5 seconds), and IDEEL-SB score (95% upper confidence limit,12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported.The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.

To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon).Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial.Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision.Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria.The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances.Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P0.001) and DCIVA (difference of 0.26 logMAR; P0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6.The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.

To compare the ocular hypotensive efficacy and safety of a fixed-dose combination (FDC) of the Rho kinase inhibitor netarsudil and latanoprost vs monotherapy with netarsudil or latanoprost.Three-month primary endpoint analysis of a randomized, double-masked, phase 3 clinical trial.Adults with open-angle glaucoma or ocular hypertension (unmedicated intraocular pressure [IOP]20 and36 mm Hg at 8:00 AM) were randomized to receive once-daily netarsudil/latanoprost FDC, netarsudil 0.02%, or latanoprost 0.005% for up to 12 months. The primary efficacy endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3.Mean treated IOP ranged from 14.8-16.2 mm Hg for netarsudil/latanoprost FDC, 17.2-19.0 mm Hg for netarsudil, and 16.7-17.8 mm Hg for latanoprost. Netarsudil/latanoprost FDC met the criteria for superiority to each active component at all 9 time points (all P .0001), lowering IOP by an additional 1.8-3.0 mm Hg vs netarsudil and an additional 1.3-2.5 mm Hg vs latanoprost. At month 3, the proportion of patients achieving mean diurnal IOP ≤15 mm Hg was 43.5% for netarsudil/latanoprost FDC, 22.7% for netarsudil, and 24.7% for latanoprost. No treatment-related serious adverse events were reported; treatment-related systemic adverse events were minimal. The most frequent ocular adverse event was conjunctival hyperemia (netarsudil/latanoprost FDC, 53.4%; netarsudil, 41.0%; latanoprost, 14.0%), which led to treatment discontinuation in 7.1% (netarsudil/latanoprost FDC), 4.9% (netarsudil), and 0% (latanoprost) of patients.Once-daily netarsudil/latanoprost FDC demonstrated IOP reductions that were statistically and clinically superior to netarsudil and latanoprost across all 9 time points through month 3, with acceptable ocular safety.

Purpose To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. Setting Twenty-four ophthalmic clinical practices in the United States. Design Prospective randomized parallel-arm controlled multicenter subject-masked study. Methods Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. Results Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation ( P P Conclusions In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress. Financial Disclosure Proprietary or commercial disclosures are listed after the references.

Robert Lehmann,1 Satish Modi,2 Bret Fisher,3 Magda Michna,4 Michael Snyder5 1Lehmann Eye Center, Nacogdoches, TX, 2Seeta Eye Center, Poughkeepsie, NY, 3The Eye Center of North Florida, Panama City, FL, 4Department of Clinical Trial Management, Alcon Laboratories, Inc., Fort Worth, TX, 5Cincinnati Eye Institute, Cincinnati, OH, USA Purpose: The purpose of this study was to evaluate the clinical outcomes of apodized diffractive +3.0 D multifocal toric intraocular lens (IOL) implantations in subjects with preoperative corneal astigmatism.Patients and methods: This was a prospective cohort study conducted at 21 US sites. The study population consisted of 574 subjects, aged ≥21 years, with preoperative astigmatism 0.75–2.82 D, and potential postoperative visual acuity (VA) ≥0.2 logMAR, undergoing bilateral cataract removal by phacoemulsification. The intervention was bilateral implantation of aspheric apodized diffractive +3.0 D multifocal toric or spherical multifocal nontoric IOLs. The main outcome measures were monocular uncorrected near and distance VA and safety at 12 months.Results: A total of 373/386 and 182/188 subjects implanted with multifocal toric and nontoric IOLs, respectively, completed 12-month follow-up after the second implantation. Toric IOLs were noninferior in monocular uncorrected distance (4 m) and near (40 cm) VA but had >1 line better binocular uncorrected intermediate VA (50, 60, and 70 cm) than nontoric IOLs. Toric IOLs reduced cylinder to within 0.50 D and 1.0 D of target in 278 (74.5%) and 351 (94.1%) subjects, respectively. Mean ± standard deviation (SD) differences between intended and achieved axis orientation in the first and second implanted eyes were 5.0°±6.1° and 4.7°±4.0°, respectively. Mean ± SD 12-month IOL rotations in the first and second implanted eyes were 2.7°±5.8° and 2.2°±2.7°, respectively. No subject receiving toric IOLs required secondary surgical intervention due to optical lens properties.Conclusion: Multifocal toric IOLs were noninferior to multifocal nontoric IOLs in uncorrected distance and near VAs in subjects with preexisting corneal astigmatism and effectively corrected astigmatism of 0.75–2.82 D. Keywords: AcrySof® IQ ReSTOR, corneal astigmatism, phacoemulsification, target cylinder, axis orientation, IOL rotation lens, visual acuity

To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power.Twelve study centers in the United States.This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed.Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs.Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.

To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation.Twenty-one ophthalmology clinics in the United States.A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores.The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P.0001). No treatment-related ocular adverse events occurred in either group.Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.