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Lisa Nijm,1,2 Cynthia Matossian,3 Michelle K Rhee,4 John D Stephens,5 Maria E Rosselson,6 Parag A Majmudar,6 Subba Rao Gollamudi,7 Ravi H Patel,8 Aditi Bauskar,9 Alyssa Montieth,9 Srilatha Vantipalli,9 Andrea Gibson,9 Jamie Lynne Metzinger,9 Michael H Goldstein,9 Rabia Gurses Ozden9 1Warrenville EyeCare and LASIK, Warrenville, IL, USA; 2University of Illinois Eye and Ear Infirmary, Chicago, IL, USA; 3CM Associates, LLC, New Hope, PA, USA; 4Icahn School of Medicine at Mount Sinai, New York, NY, USA; 5Tyson Eye, Fort Myers, FL, USA; 6Chicago Cornea Consultants, Ltd, Chicago, IL, USA; 7Eye Specialty Group, Memphis, TN, USA; 8Eye Associates of Central Texas, Round Rock, TX, USA; 9Ocular Therapeutix, Inc, Bedford, MA, USACorrespondence: Aditi Bauskar, Ocular Therapeutix, Inc, 15 Crosby Drive, Bedford, MA, 01730, USA, Tel +1 210-452-8029, Email abauskar@ocutx.comPurpose: To evaluate both the early experience of real-world patients treated with dexamethasone ophthalmic insert (0.4 mg; DEXTENZA®), hereafter referred to as DEX, after cataract surgery as well as staff/practice integration of DEX relative to eyedrops.Patients and Methods: This was a cross-sectional survey study of 23 cataract practices in the United States. Respondents were patients and practice staff who had experience with DEX following cataract surgery. Both patients and practice staff completed an online survey. Descriptive statistics summarized the survey responses to portray the experience of the respondents.Results: Surveys were completed by 62 patients and 19 practice staff. Almost all patients (93%) were satisfied or extremely satisfied with DEX. Patients highly preferred DEX (93%) to topical steroid drops (7%) based on past experiences with topical steroid drops. Most practice staff (95%) were satisfied or highly satisfied with DEX, reporting a 45% reduction in time spent educating patients on postoperative drop use and a 46% decrease in time spent addressing calls from pharmacies regarding postoperative medications.Conclusion: Incorporating the DEX insert into clinical practice in cataract surgery practices can improve patient adherence, while potentially providing significant savings to practices in terms of time spent educating patients and responding to patient and pharmacy call-backs.Keywords: intracanalicular dexamethasone insert, phacoemulsification, hands-free therapy, ocular pain, ocular inflammation, sustained-release drug delivery

Cynthia Matossian,1 John D Stephens,2 Michelle K Rhee,3 Stephen E Smith,4 Parag A Majmudar,5 Subba Rao Gollamudi,6 Ravi H Patel,7 Maria E Rosselson,5 Aditi Bauskar,8 Alyssa Montieth,8 Fabiana Q Silva,8 Srilatha Vantipalli,8 Andrea Gibson,8 Jamie Lynne Metzinger,8 Michael H Goldstein8 1CM Associates, LLC, New Hope, PA, USA; 2Tyson Eye, Fort Myers, FL, USA; 3Icahn School of Medicine at Mount Sinai, New York, NY, USA; 4Eye Associates, Fort Myers, FL, USA; 5Chicago Cornea Consultants, Ltd., Chicago, IL, USA; 6Eye Specialty Group, Memphis, TN, USA; 7Eye Associates of Central Texas, Round Rock, TX, USA; 8Ocular Therapeutix, Inc., Bedford, MA, USACorrespondence: Srilatha Vantipalli, Ocular Therapeutix, Inc, 24 Crosby Drive, Bedford, MA, 01730, USA, Tel +1 413-230-7242, Email SVantipalli@ocutx.comPurpose: To describe the early real-world experience of physicians with an intracanalicular dexamethasone insert (DEX) in patients undergoing cataract surgery and to capture the clinical impact of adopting this therapy.Patients and Methods: 23 United States sites including Ambulatory Surgical Center Setting (ASC) and Outpatient Clinical settings. Respondents were physicians who had early experience with DEX in cataract surgery patients. This was a Phase 4 experiential cross-sectional survey study comprised of 3 sequential online physician surveys. Descriptive statistics summarized the surveys’ responses to determine the early impressions of the respondents.Results: Forty-two physicians completed surveys. On average, physicians reported feeling comfortable administering DEX after placing 3 inserts (mean 2.7; standard deviation 1.9). Most physicians (92%) were satisfied with DEX, and all physicians (100%) reported that DEX improved patient compliance. Most physicians (62.5%) indicated they would highly prefer DEX over traditional steroid eyedrops for the management of post-surgical inflammation and pain.Conclusion: The surveys exploring the early use of DEX suggest that DEX is a clinically effective treatment with a rapid initial learning curve and integrates well into clinical use. Physicians had a very positive early experience with DEX, including comfort with insertion and satisfaction. DEX shows promise as a primary treatment choice of physicians for ocular inflammation and pain following cataract surgery by offering patients a hands-free innovative therapy that delivers a preservative-free steroid to the ocular surface over approximately 30 days.Keywords: intracanalicular dexamethasone insert, phacoemulsification, hands-free therapy, ocular pain, ocular inflammation, sustained-release drug delivery

Neel S Vaidya,1,2 Arvin Daneshmand,3 Randy J Epstein,1,2 Parag A Majmudar,1,2 Michael W Belin,4,5 Edward C Parsons,5 Roy S Rubinfeld5– 7 1Chicago Cornea Consultants, Highland Park, IL, USA; 2Department of Ophthalmology, Rush University Medical Center, Chicago, IL, USA; 3Georgetown University Medical School, Washington, DC, USA; 4Department of Ophthalmology, University of Arizona, Tucson, AZ, USA; 5CXL Ophthalmics, LLC, Encinitas, CA, USA; 6Department of Ophthalmology, Georgetown University Medical School/Washington Hospital Cente, Washington, DC, USA; 7Re:Vision Private Practice, Rockville, MD, USACorrespondence: Neel S Vaidya, Chicago Cornea Consultants, 806 Central Ave Suite 300, Highland Park, IL, 60035, USA, Email nsv@chicagocornea.comPurpose: To assess the change in corneal pachymetry after a novel epithelium-on (EpiSmart®) corneal crosslinking procedure (CXL).Methods: Eyes treated as part of the open-label, non-controlled arm of the study “Collagen Crosslinking with Ultraviolet-A in Asymmetric Corneas” (NCT01097447) were examined at baseline, 3-, 6- and 12-months post-CXL. Thinnest pachymetry readings based on Pentacam (OCULUS GmbH, Wetzlar, Germany) were recorded.Results: A total of 101 eyes met the study inclusion criteria. Thinnest pachymetric readings at baseline averaged 451 ± 50 microns. The mean (± SD) minimum thickness was 450 ± 46 microns at 3 months, 452 ± 47 microns at 6 months, and 451 ± 48 microns at 12 months post-CXL. The changes from baseline (mean ± SE) at 3, 6, and 12 months post-CXL were − 1.2 ± 1.5 microns, 0.5 ± 1.6 microns, and 0.4 ± 1.6 microns, respectively. Student’s t-tests showed no statistically significant change in pachymetry from baseline for any exam period.Conclusion: This study demonstrated that, after EpiSmart® epithelium-on CXL, there was no substantial corneal thinning observable on Scheimpflug tomography out to 12 months.Keywords: corneal thinning, cross-linking, epithelium-on, keratoconus, pachymetry, post-surgical ectasia

Sarah J Bond,1 Nathan Parikh,1 Shrey Majmudar,1 Sabrina Pin,1 Christine Wang,1 Lauren Willis,1 Susanne B Haga1,2 1Duke University, Durham, NC, 27708, USA; 2Duke University School of Medicine, Durham, NC, 27708, USACorrespondence: Susanne B HagaDuke University, 101 Science Drive, Box 3382, Durham, NC, 27708, USA, Tel +1 919 684 0325, Fax +1 919 681 8973, Email susanne.haga@duke.eduBackground: Despite the purported advantages and potential efficacy of mHealth interventions to promote wellness in children, adolescents, and young adults, it is not clear what areas have been explored and the challenges reported in the biomedical literature.Methods: We conducted a scoping review of publications between 2015 and 2019.Results: We identified 54 papers that met our inclusion criteria. Studies were conducted in 21 countries and ranged in size from six to 9851 participants (median: 184). A total of 41% of studies enrolled adolescents only (n = 19). Of the seven types of mHealth interventions identified, apps were the most common intervention (59%; n = 32) evaluated and 44% of the studies evaluated two or more interventions. The most common topic of the studies reviewed was sexual and reproductive health (24%; n = 13).Conclusion: Most pediatric mHealth intervention studies are conducted in adolescents in large part, and sexual and reproductive health is the most commonly studied topic. With the easy and widespread accessibility to smartphone technology, the use of mobile apps for wellness interventions will likely continue to expand to other wellness topics.Keywords: mHealth, wellness, children, adolescents, young adults

Kelly K Nichols,1 Edward Holland,2 Melissa M Toyos,3 James H Peace,4 Parag Majmudar,5 Aparna Raychaudhuri,6 Mohamed Hamdani,6 Monica Roy,6 Amir Shojaei6 1School of Optometry, University of Alabama at Birmingham, Birmingham, AL, 2Cincinnati Eye Institute, Edgewood, KY, 3Toyos Clinic, Nashville, TN, 4United Medical Research Institute, Inglewood, CA, 5Chicago Cornea Consultants, Ltd., Hoffman Estates, IL, 6Shire, Lexington, MA, USA Purpose: To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED) in the OPUS-3 trial. Methods: OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo) to ophthalmic drops twice daily for 84 days. On days 0 (baseline), 14, 42, and 84, drop comfort score (scale, 0–10; 0 = very comfortable, 10 = very uncomfortable) was measured at 0, 1, 2, and 3 minutes postinstillation. If the score was >3 at 3 minutes, assessment was repeated at 5, 10, and 15 minutes until score ≤3. Ocular treatment-emergent adverse events (TEAEs) were assessed. Results: Overall, 711 participants were randomized (n=357 received lifitegrast; n=354 received placebo). Drop comfort scores for lifitegrast-treated participants improved within 3 minutes of instillation (mean scores on day 84 for both study and fellow eyes: instillation: lifitegrast, 3.4, placebo, 1.0; 3 minutes: lifitegrast, 1.5, placebo, 0.7). The majority (64%–66%) of participants had scores 3 at 3 minutes, the mean score in the lifitegrast group was similar to or better than that in the placebo group at 5, 10, or 15 minutes postinstillation. Lifitegrast appeared to be well tolerated, with ocular TEAEs rarely leading to discontinuation. Conclusion: In OPUS-3, lifitegrast appeared to be well tolerated and drop comfort scores approached placebo levels by 3 minutes postinstillation. Keywords: drop comfort, dry eye disease, lifitegrast ophthalmic solution 5.0%, ocular comfort, OPUS-3

Gail Torkildsen,1 Mile Brujic,2 Michael S Cooper,3 Paul Karpecki,4 Parag Majmudar,5 William Trattler,6 Meryl Reis,7 Joseph B Ciolino1,8 1Andover Eye Clinic, Andover MA, 2Premier Vision Group, Bowling Green, OH, 3Windam Eye Group, Willimantic, CT, 4Gaddie Eye Center, Louisville KY, 5Chicago Cornea Consultants, Chicago IL, 6Center For Excellence in Eye Care, Miami, FL, 7Rohto Mentholatum Research Laboratories, Horsham, PA, 8Massachusetts Eye and Ear Infirmary, Boston MA, USA Purpose: Artificial tears are the first line of therapy for dry eye disease (DED) and are also the most frequently used treatment approach for this common condition. Despite this, there are few published studies that directly compare the effectiveness of different drop preparations, especially those formulated specifically for dry eye. In this study, we tested a new artificial tear product, Rohto® Dry-Aid™, for its ability to relieve the signs and symptoms of DED. The study used a second drop, Systane® Ultra, as a positive comparator.Materials and methods: This was a prospective, single-center, open-label, parallel-group study comparing the effects of the two products when used continuously over ~30 days (Clinical Trials registration number NCT03183089). Subjects were randomly assigned to one of the two test groups and were monitored 2 and 4 weeks after enrollment. Efficacy endpoints included ocular staining, visual function, and ocular discomfort.Results: Treatment groups had similar ocular staining and ocular comfort scores, and both showed statistically significant ocular discomfort score improvement. Subjects in the Rohto group reported significant improvements in visual tasking activities such as watching television and driving at night. There was also a tendency for diary symptom scores to worsen from morning to evening in the Systane group, but not in the Rohto group; this trend was not significant, but warrants further study.Conclusion: The two products, Rohto Dry-Aid and Systane Ultra, elicited comparable effects on the signs and symptoms of DED. While both products are designed to provide long-lasting relief, subjects in the Rohto group experienced a superior relief from discomfort associated with visual tasking activities and daily diaries, indicating that the Rohto drops may provide a longer duration of symptomatic relief over the course of the day. Keywords: artificial tears, dry eye, ocular surface, visual tasking, blurred vision

William B Trattler,1 Parag A Majmudar,2 Eric D Donnenfeld,3 Marguerite B McDonald,4 Karl G Stonecipher,5 Damien F Goldberg6 On behalf of the PHACO Study Group 1Center for Excellence in Eye Care, Miami, FL, USA; 2Chicago Cornea Consultants, Chicago, IL, USA; 3Ophthalmic Consultants of Long Island, Garden City, NY, USA; 4Ophthalmic Consultants of Long Island, Lynbrook, NY, USA; 5University North Carolina School of Medicine, Chapel Hill, NC, USA; 6Wolstan & Goldberg Eye Associates, Torrance, CA, USA Purpose: To determine the incidence and severity of dry eye as determined by the International Task Force (ITF) scale in patients being screened for cataract surgery.Patients and methods: This was a prospective, multi-center, observational study of 136 patients, at least 55 years of age, who were scheduled to undergo cataract surgery. The primary outcome measure was the incidence of dry eye as evaluated by grade on the ITF scale and secondary outcome measures include tear break-up time (TBUT), ocular surface disease index score, corneal staining with fluorescein, conjunctival staining with lissamine green, and a patient questionnaire to evaluate symptoms of dry eye.Results: Mean patient age was 70.7 years. A total of 73.5% of patients were Caucasian and 50% were female. Almost 60% had never complained of a foreign body sensation; only 13% complained of a foreign body sensation half or most of the time. The majority of patients (62.9%) had a TBUT ≤5 seconds, 77% of eyes had positive corneal staining and 50% of the eyes had positive central corneal staining. Eighteen percent had Schirmer’s score with anesthesia ≤5 mm.Conclusion: The incidence of dry eye in patients scheduled to undergo cataract surgery in a real-world setting is higher than anticipated. Keywords: cataract surgery screening, dry eye, International Task Force scale, observational study

BackgroundWearable and connected health devices along with the recent advances in mobile and cloud computing provide a continuous, convenient-to-patient, and scalable way to collect personal health data remotely. The Wavelet Health platform and the Wavelet wristband have been developed to capture multiple physiological signals and to derive biometrics from these signals, including resting heart rate (HR), heart rate variability (HRV), and respiration rate (RR). ObjectiveThis study aimed to evaluate the accuracy of the biometric estimates and signal quality of the wristband. MethodsMeasurements collected from 35 subjects using the Wavelet wristband were compared with simultaneously recorded electrocardiogram and spirometry measurements. ResultsThe HR, HRV SD of normal-to-normal intervals, HRV root mean square of successive differences, and RR estimates matched within 0.7 beats per minute (SD 0.9), 7 milliseconds (SD 10), 11 milliseconds (SD 12), and 1 breaths per minute (SD 1) mean absolute deviation of the reference measurements, respectively. The quality of the raw plethysmography signal collected by the wristband, as determined by the harmonic-to-noise ratio, was comparable with that obtained from measurements from a finger-clip plethysmography device. ConclusionsThe accuracy of the biometric estimates and high signal quality indicate that the wristband photoplethysmography device is suitable for performing pulse wave analysis and measuring vital signs.

Steven A Nielsen,1 Marguerite B McDonald,2 Parag A Majmudar31Nielsen Eye Center, Quincy, MA, USA; 2Ophthalmic Consultants of Long Island, Lynbrook, NY, USA; 3Chicago Cornea Consultants Hoffman Estates, IL, USABackground: To evaluate the safety of besifloxacin ophthalmic suspension 0.6% when used in laser-assisted in situ keratomileusis (LASIK) prophylactic antibiotic regimens.Methods: Retrospective surveillance of LASIK surgery cases where besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% were prescribed as prophylactic medications. Surgeons from nine US surgical centers provided retrospective case information on surgical outcomes from consecutive cases and reported any adverse events related to the antibacterial used. The primary endpoint was the incidence of adverse drug reactions.Results: A total of 801 case reports (801 eyes; 534 besifloxacin, 267 moxifloxacin) were obtained. The mean (standard deviation [SD]) age at time of surgery was 36.1 (10.6) years. The mean (SD) duration of antibiotic treatment was 8.6 (2.2) days in the besifloxacin group and 8.0 (2.3) in the moxifloxacin group; daily dosing frequency was higher in the moxifloxacin group preoperatively, on the day of surgery, and postoperatively. There were no reports of adverse drug reactions for the 801 eyes in this surveillance. There were no differences between the besifloxacin and moxifloxacin treatment groups in rates of unexpected corneal findings (2.1% vs 1.5%, P = 0.949). The distribution of final visual acuity for the besifloxacin and moxifloxacin groups were similar (P = 0.793). Most cases had a final visual acuity of 20/20 or better.Conclusion: In this retrospective surveillance study, the prophylactic use of besifloxacin ophthalmic suspension 0.6% and moxifloxacin ophthalmic solution 0.5% in patients undergoing LASIK surgery was not associated with any adverse drug reactions.Keywords: Besivance, refractive surgery, adverse drug reactions LASIK, moxifloxacin ophthalmic solution 0.5%, ocular infection prophylaxis

PurposeEvaluate the initial ocular safety and tolerability and efficacy of VVN001 Ophthalmic Solution (VVN001), a small-molecule antagonist of lymphocyte function-associated antigen-1 (LFA-1), in subjects with dry eye disease (DED).MethodsThis was a multi-center, double-masked, randomized, dose-response, vehicle-controlled, parallel-group study conducted in 170 subjects with DED. Subjects were randomized to receive VVN001 (1% or 5%) or its vehicle, twice-daily in both eyes for 84 days. The primary outcome measure was inferior region corneal fluorescein staining (iCFS, 0-4 scale) at Day 84. Visual Analogue Scale eye dryness (VAS, 0-100 scale) was a secondary outcome.ResultsThe primary and first secondary outcomes were not met. At Day 84 treatment effects in favor of VVN001 5% relative to its vehicle for iCFS were 0.29 units (p = 0.054), and for VAS were 3.18 units (p = 0.533). In other secondary outcomes, treatment effects in favor of VVN001 5% relative to its vehicle were seen in total CFS (1.61 units, 0-20 scale, p = 0.004) and Schirmer score (1.77 and 2.32 mm, p = 0.049 and p = 0.17 at Days 14 and 28 respectively). Adverse events of incidence 5% or greater in either active treatment group were instillation site pain (3/57, 5.3%), dysgeusia (3/56, 5.4%) and urinary tract infection (3/57, 5.3%).ConclusionsThere were no major safety issues of note. Appropriately powered studies will be required with a priori selection of the efficacy endpoints to evaluate VVN001's therapeutic potential.