The impact of Demodex blepharitis on patient symptoms and daily life.

SIGNIFICANCE: Patients with Demodex blepharitis have a considerable symptomatic burden that negatively impacts their daily activities and well-being. Despite chronic manifestations of and problems associated with blepharitis that resulted in multiple visits to eye care providers, Demodex blepharitis remained underdiagnosed or misdiagnosed. PURPOSE: This study aimed to evaluate the effect of Demodex blepharitis on patients' daily activities and well-being. METHODS: This prospective, multicenter, observational study recruited 524 patients with Demodex blepharitis from 20 U.S. ophthalmology and optometry practices. Demodex blepharitis was diagnosed based on the presence of the following clinical manifestations in at least one eye: >10 collarettes on the upper lashes, at least mild lid margin erythema of the upper eyelid, and mite density of ≥1.0 mite/lash (upper and lower combined). Patients were asked to complete a questionnaire related to their symptoms, daily activities, and management approaches. RESULTS: The proportion of patients who experienced blepharitis symptoms for ≥2 years was 67.8%, and for ≥4 years, it was 46.5%. The three most bothersome symptoms ranked were "itchy eyes," "dry eyes," and "foreign body sensation." Overall, 77.4% of patients reported that Demodex blepharitis negatively affected their daily life. One-third (32.3%) of patients had visited a doctor for blepharitis at least two times, including 19.6% who visited at least four times. Despite having clinical manifestations of Demodex blepharitis confirmed by an eye care provider, 58.7% had never been diagnosed with blepharitis. Commonly used management approaches were artificial tears, warm compresses, and lid wipes. Among those who discontinued their regimen, 45.9% had discontinued because of either tolerability issues or lack of effectiveness. Among contact lens wearers, 64.3% of the patients either were uncomfortable wearing contact lenses or experienced vision changes "sometimes" or "frequently." CONCLUSION: Demodex blepharitis results in a significant negative impact on daily activities, creating a psychosocial and symptomatic burden on patients.

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.

Demodex Blepharitis: A Comprehensive Review of the Disease, Current Management, and Emerging Therapies.

ABSTRACT: Demodex blepharitis is a common disease of the eyelid, affecting approximately 25 million Americans. This article reviews what is known about the mechanisms and impact of Demodex blepharitis, risk factors, signs and symptoms, diagnostic techniques, current management options, and emerging treatments. Demodex mites contribute to blepharitis in several ways: direct mechanical damage, as a vector for bacteria, and by inducing hypersensitivity and inflammation. Risk factors for Demodex blepharitis include increasing age, rosacea, and diabetes. The costs, symptom burden, and psychosocial effects of Demodex blepharitis are considerable. The presence of collarettes is pathognomonic for Demodex blepharitis. Redness, dryness, discomfort, foreign body sensation, lash anomalies, and itching are also hallmarks of the disease. Although a number of oral, topical, eyelid hygiene and device-based options have been used clinically and evaluated in studies for the management of Demodex blepharitis, none have been FDA approved to treat the disease. Recent randomized controlled clinical trials suggest that lotilaner ophthalmic solution, 0.25%, is a topical treatment with the potential to eradicate Demodex mites and eliminate collarettes and eyelid redness for an extended period.

Matching the Patient to the Intraocular Lens: Preoperative Considerations to Optimize Surgical Outcomes.

The intraocular lens (IOL) selection process for patients requires a complex and objective assessment of patient-specific ocular characteristics, including the quality and quantity of corneal astigmatism, health of the ocular surface, and other ocular comorbidities. Potential issues that could be considered complications after surgery, including dry eye disease, anterior or epithelial basement membrane dystrophy, Salzmann nodular degeneration, and pterygium, should be addressed proactively. Aspheric IOLs are designed to eliminate the positive spherical aberration added by traditional IOLs to the pseudophakic visual axis. Spherical aberration may be a consideration with patient selection. Patient desire for increased spectacle independence after surgery is one of the main drivers for the development of multifocal IOLs and extended depth-of-focus (EDOF) IOLs. However, no one single multifocal or EDOF IOL suits all patients' needs. The wide variety of multifocal and EDOF IOLs, their optics, and their respective impact on patient quality of vision have to be understood fully to choose the appropriate IOL for each individual, and surgery has to be customized. Patients who have undergone previous LASIK or who have radial keratotomy and ocular pathologic features, including glaucoma, age-related macular degeneration, and epiretinal membrane, require specific considerations for IOL selection. Subjectively, patient-centered considerations, including visual goals, lifestyle, personality, profession, and hobbies, are key elements for the surgeon to assess and factor into an IOL recommendation. This holistic approach will help surgeons to achieve optimal surgical outcomes and to meet (and exceed) the high expectations of patients.

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens.

PURPOSE: 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). DESIGN: Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial. PARTICIPANTS: 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. METHODS: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria. MAIN OUTCOME MEASURES: 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. RESULTS: 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 was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) 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. CONCLUSIONS: 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.

Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment.

Dysfunctional tear syndrome (DTS) is a common and complex condition affecting the ocular surface. The health and normal functioning of the ocular surface is dependent on a stable and sufficient tear film. Clinician awareness of conditions affecting the ocular surface has increased in recent years because of expanded research and the publication of diagnosis and treatment guidelines pertaining to disorders resulting in DTS, including the Delphi panel treatment recommendations for DTS (2006), the International Dry Eye Workshop (DEWS) (2007), the Meibomian Gland Dysfunction (MGD) Workshop (2011), and the updated Preferred Practice Pattern guidelines from the American Academy of Ophthalmology pertaining to dry eye and blepharitis (2013). Since the publication of the existing guidelines, new diagnostic techniques and treatment options that provide an opportunity for better management of patients have become available. Clinicians are now able to access a wealth of information that can help them obtain a differential diagnosis and treatment approach for patients presenting with DTS. This review provides a practical and directed approach to the diagnosis and treatment of patients with DTS, emphasizing treatment that is tailored to the specific disease subtype as well as the severity of the condition.

An update on new low add multifocal intraocular lenses.

PURPOSE OF REVIEW: The purpose of this article is to provide an overview and update on recent literature regarding low-add multifocal intraocular lenses (MFIOLs). RECENT FINDINGS: Clinical and benchwork studies involving low-add MFIOLs were reviewed. Clinical studies focused on uncorrected distance, intermediate, and near vision, along with secondary dysphotopsias. Studies done in the laboratory assessed the optical properties of various lenses, and optically replicated visual scenarios at different viewing distances. SUMMARY: MFIOLs continue to evolve to meet the needs of an evolving patient population. Low-add MFIOLs have been shown to improve intermediate vision, while not compromising distance vision, along with decreasing dysphotopsias. Their optical properties continue to be optimized, and with these new improvements, larger groups of patients can benefit from the range of vision provided. It is important to understand the strengths and limitations of these new MFIOLs, this review provided the most up to date review of the literature describing low-add MFIOLs. The new information provided by these reviewed articles allows the ophthalmologist to provide the best options for each individual patient.

Ocular surface diseases and corneal refractive surgery.

PURPOSE OF REVIEW: The purpose of this article is to provide an overview and update on recent literature regarding ocular surface disease and corneal refractive surgery. RECENT FINDINGS: Studies involving ocular surface disease and/or keratorefractive (corneal) surgery published found on the Medline database were included in the report. Studies focused on mechanisms of refractive surgery induced dry eye disease, surgical options, including modification of technique, to prevent dry eye, and postoperative dry eye prevention and management by way of both established and novel therapies. SUMMARY: By understanding the mechanisms of postoperative dry eye as well as patient risk factors for dry eye, patient satisfaction and surgical outcomes can be maximized. Patients identified as having an increased risk for postoperative dry eye may benefit from surgical techniques such as small-incision lenticule extraction (SMILE) and femtosecond laser-assisted in-situ keratomileusis (LASIK). Employing well known therapies such as preserved and nonpreserved artificial tears, nutritional supplements, topical cyclosporins, punctal plugs and autologus serum as well as novel therapies such as insulin-like growth factor 1, neuropeptides and acupuncture could provide improve outcomes and, if started early, could allow more patients to be candidates for corneal refractive surgery.

Sensitivity and specificity of SS-OCT for detecting macular pathologies vs SD-OCT.

PURPOSE: To evaluate the sensitivity and specificity of swept-source optical coherence tomography (SS-OCT) biometer compared with the gold standard spectral-domain optical coherence tomography (SD-OCT) for detecting macular pathology in patients with cataract. SETTING: Eye Centers of Tennessee, Crossville, TN. DESIGN: Prospective, cross-sectional, observational, examiner-masked. METHODS: The study included 132 participants aged 50 years and older, who underwent precataract surgery work-up. All participants underwent fixation check retinal scans using SS-OCT biometer (IOLMaster 700) as well as full macular scans using Cirrus SD-OCT. 3 independent masked examiners evaluated the scans if they were normal or had a suspected pathology. Different measures of diagnostic accuracy were calculated for 3 examiners. RESULTS: True positive rate (sensitivity) ranged from 71.1% (32/45) to 79.2% (42/53), and false negative rate was between 20.8% (11/53) and 28.9% (13/45) for the 3 examiners. True negative rate (specificity) ranged from 86.8% (59/68) to 94.1% (64/68), and false positive rate was between 5.9 (4/68) and 13.2% (9/68). The fitted receiver operating characteristic area ranged from 0.83 to 0.95. CONCLUSIONS: Using retinal SS-OCT biometer scans as a replacement of the dedicated macular SD-OCT for screening or diagnosing macular health would not be appropriate because of its low sensitivity. SS-OCT biometer may potentially fail to identify approximately one-fourth of patients who actually have the disease. Therefore, the final decision on macular health should be based on the gold standard SD-OCT scans. When full macular SD-OCT scans are not accessible, the limited retinal scan information from SS-OCT biometer may still provide useful insights into the macular health.

First in-human clinical performance of a new non-cavitating handheld lensectomy system in 665 consecutive cataract surgeries.

PURPOSE: To investigate the intraoperative performance and lens fragmentation efficacy of a non-cavitating handheld lensectomy system in mild, moderate, and severe cataract. SETTING: Ambulatory surgical centers. DESIGN: Retrospective consecutive case series. METHODS: 665 consecutive eyes underwent cataract surgery by 12 surgeons using a new handheld non-cavitating lensectomy system for nuclear fragmentations and extraction. Intraoperative measurements included surgical time, miLOOP pretreatment, and irrigation fluid use. RESULTS: Of the 665 eyes, 38 (6%), 468 (70%), 126 (19%), and 33 (5%) were of grade 1, 2, 3, and 4 nuclear densities, respectively, as graded by the surgeon intraoperatively. Successful nuclear fragmentation, lens extraction, and cortical removal were achieved in all eyes. Total nucleus fragmentation and extraction times were 70.1 seconds, 100.3 seconds, 132.6 seconds, and 287.9 seconds for grades 1, 2, 3, and 4, respectively ( P < .001). In addition, irrigation and aspiration cortical removal times were 64.1 seconds, 51.1 seconds, 48.5 seconds, and 59.0 seconds, respectively ( P = .14). There was a low rate of capsular tear (3 cases in 665 surgeries, 0.45%) and no other emergent adverse events. CONCLUSIONS: The miCOR handheld non-cavitating lensectomy system demonstrated nuclear fragmentation and extraction in the absence of intraocular cavitation across all grades of nuclear densities.

Evaluating the small aperture intraocular lens: depth of focus and the role of refraction and preoperative corneal astigmatism on visual performance.

PURPOSE: To evaluate depth of focus (DOF) and visual acuities (VAs) by manifest refractive spherical equivalent (MRSE) and degree of preoperative corneal astigmatism with the IC-8® small aperture intraocular lens (SA IOL) (AptheraTM, Bausch & Lomb, Inc). SETTING: 21 investigational sites in the United States. DESIGN: Prospective, multi-center, open-label, parallel-group, non-randomized, examiner-masked, one-year clinical study. METHODS: Included patients had cataract and ≤1.5D preoperative corneal astigmatism. Patients received either the SA IOL in one eye targeted to -0.75D and a monofocal or monofocal toric IOL in the other targeted to plano (SA IOL Group) or bilateral monofocal/monofocal toric IOLs targeted to plano (Control Group). Monocular and binocular assessments included defocus curves and uncorrected VAs (distance, intermediate, and near) by postoperative MRSE; monocular VAs were assessed by degree of preoperative corneal astigmatism. RESULTS: The SA IOL Group (n=343) achieved 0.82D additional binocular DOF versus the Control Group (n=110), and SA IOL eyes achieved 0.91D additional monocular DOF over fellow eyes. Across all MRSEs, the SA IOL Group achieved monocular uncorrected VAs of 20/40 or better and binocular uncorrected VAs of 20/32 or better across all distances. Additionally, SA IOL eyes with higher (1.0-1.5D) versus lower (<1.0D) preoperative corneal astigmatism achieved equivalent monocular uncorrected VAs. CONCLUSIONS: The SA IOL provides increased DOF versus monofocal/monofocal toric IOLs and consistent monocular and binocular vision across several postoperative MRSEs and up to 1.5D of preoperative corneal astigmatism, giving patients with cataract and mild astigmatism the potential for an extended range of vision and reliable visual outcomes.

Current state and future perspectives in the diagnosis of eyelid margin disease: clinical review.

The eyelid margin is vital to ocular surface integrity. Much peer-reviewed literature has been established in eyelid margin inflammation, better known as blepharitis. The purpose was to review and understand the impact of eyelid margin disease. Anterior blepharitis causes inflammation at the eyelash base, ciliary follicles, and the palpebral skin. Posterior blepharitis occurs when there is inflammation with the posterior eyelid margin disease. In common usage, the term "blepharitis" used alone almost always refers to anterior blepharitis. Classification of eyelid margin disease should be based on etiopathogenesis, location, primary vs secondary, and chronicity. Blepharitis has several etiopathologies (infectious, inflammatory, and squamous). Meibomian gland dysfunction (MGD) can refer to the functional and/or structural problems with the meibomian gland. Meibomitis (or meibomianitis) occurs when there is inflammation associated with the MGD. The presence of blepharitis and/or MGD (with or without inflammation) can affect the ocular surface and thereby affect anterior segment and cataract surgeries. This review article evaluates the differential diagnoses of eyelid margin disease, including various forms of blepharitis, MGD, and meibomitis.

Eyelid margin disease (blepharitis and meibomian gland dysfunction): clinical review of evidence-based and emerging treatments.

Blepharitis is a common ophthalmic condition with multiple etiologies and no definitive, universal treatment. The treatment modalities for managing lid margin diseases vary depending on the disease's cause, location, and severity. For anterior blepharitis, management options include eyelid hygiene with warm compresses, eyelid scrubs, baby shampoo, and over-the-counter eyelid cleansers. Topical antibiotics and antibiotic-steroid combination drops/ointments for the eye and eyelid may accompany these. For posterior blepharitis/meibomian gland dysfunction (MGD), at-home warm compress or in-office administration of heat therapy/thermal pulsation treatment that aims to clear obstruction in the meibomian glands and restore meibum secretions to maintain a healthy tear film is recommended. In addition to the above treatment strategies, various other compounds to manage lid margin diseases are in the late stages of development. This review summarizes the available treatment modalities or those in the pipeline for treating blepharitis and MGD.

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.

Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study.

PURPOSE: The aim of this study was to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, in the treatment of Demodex blepharitis. METHODS: This observational, extension study included patients with Demodex blepharitis (N = 239) who completed the Saturn-1 study and presented for the day 180 visit. All participants were assessed at days 180 and 365 after the initiation of 6-week treatment with the study drug or its vehicle. RESULTS: The proportion of patients with 0 to 2 collarettes (grade 0) was significantly higher in the study group (N = 128 patients) than in the control group (N = 111 patients) (39.8% vs. 2.7% at day 180 and 23.5% vs. 2.9% at day 365; P < 0.0001). Similarly, the proportion of patients with ≤10 collarettes (collarette grade 0-1) in the study group was significantly higher than in the control group (70.3% vs. 18.0% at day 180 and 62.6% vs. 21.9% at day 365; P < 0.0001). In the study group, erythema continued to improve even after completion of the 6-week lotilaner treatment. No serious ocular adverse events were observed in the study group, and there was 1 treatment-related ocular adverse event in the study group, which was considered mild. CONCLUSIONS: After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy.

Prevalence of Meibomian Gland Atrophy in Patients Undergoing Cataract Surgery.

PURPOSE: The aim of this study was to determine the prevalence of meibomian gland (MG) atrophy in a US-based population of patients presenting for cataract surgery. METHODS: In this retrospective study, case records of 391 patients aged 50 years or older, who had undergone a preoperative cataract surgery workup with meibography, were included. The amount of atrophy in the lower eyelid was graded as described by Arita et al (grade 0 = no atrophy, grade 1 = 1%-33% atrophy, grade 2 = 34%-66% atrophy, and grade 3 = >66% atrophy), and the prevalence of MG atrophy was determined. Associations between MG atrophy and demography, comorbidities, and risk factors were evaluated. RESULTS: Overall, 95.1% of patients (372/391) had MG atrophy ≥grade 1, with 50.4% (197/391) having grade 1, 25.8% (101/391) grade 2, and 18.9% (74/391) grade 3. MG atrophy had a statistically significant correlation with MG expressibility (R = 0.22; P = 0.001), but not with meibum grade (R = 0.103; P = 0.123) and telangiectasia (R = 0.014; P = 0.787). The prevalence of MG atrophy (≥grade 1) was comparable among patients who had previously been diagnosed with dry eye disease (DED) versus those who had not; however, the severity of MG atrophy was higher in patients with previous DED diagnosis (grade 2/3: 59% vs. 30.9%). Among patients with no previous history of DED, 18% (35/194) had moderate and 13% (25/194) had severe MG atrophy. CONCLUSIONS: MG atrophy is common in patients presenting for cataract surgery evaluation, indicating potential underdiagnosis. Routine use of meibography during preoperative screening in cataract surgery patients may facilitate more timely and effective diagnosis and treatment.

Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1).

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25%, compared with vehicle for the treatment of Demodex blepharitis. METHODS: In this prospective, randomized, controlled, double-masked, phase 2b/3 clinical trial, 421 patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group), or vehicle without lotilaner (control group) bilaterally, twice daily for 43 days. Patients were evaluated at days 8, 15, 22, and 43. Outcome measures were complete collarette cure (collarette grade 0), clinically meaningful collarette cure (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes/erythema), and drop comfort. Adverse events were also evaluated. RESULTS: At day 43, the study group achieved a statistically significantly higher proportion of patients with clinically meaningful collarette cure (81.3% vs. 23.0%; P < 0.0001), complete collarette cure (44.0% vs. 7.4%; P < 0.0001), mite eradication (67.9% vs. 17.6%; P < 0.0001), erythema cure (19.1% vs. 6.9%; P = 0.0001), and composite cure (13.9% vs. 1.0%; P < 0.0001) than the control group. Nearly 92.0% of patients rated the study drop as neutral to very comfortable. All ocular adverse events in the study group were mild, with the most common being instillation site pain. CONCLUSIONS: Twice-daily treatment with a novel lotilaner ophthalmic solution, 0.25% for 43 days, is safe and effective for the treatment of Demodex blepharitis compared with the vehicle control.

Capsular phimosis with intraocular lens tilt and decentration.

A 34-year-old woman with quiescent bilateral intermediate uveitis maintained on once-daily dexamethasone 0.1% eyedrops, complicated by left cataract and glaucoma controlled with a single antiglaucoma medication, presented for cataract surgery. Her left corrected distance visual acuity (CDVA) was 20/40 because of a posterior subcapsular lens opacity. The anterior chamber angles appeared closed in all 4 quadrants on gonioscopy. Ultrasound biomicroscopy (UBM) confirmed the gonioscopy findings and, in addition, revealed a crystalline lens thickness of 5.53 mm, normal ciliary body structure, and multiple localized chorioretinal scars with membranes over the pars plana region. She underwent left phacoemulsification, goniosynechiolysis, and in-the-bag implantation of a single-piece monofocal hydrophobic acrylic intraocular lens (IOL). On the first postoperative day, she achieved pinhole vision of 20/70 (-6 diopters [D] myopia to balance with the fellow eye). There was mild anterior chamber cellular activity and flare, consistent with postoperative inflammation. Her intraocular pressure (IOP) was 16 mm Hg without antiglaucoma therapy. She was advised to continue the prednisolone acetate 1% eyedrops 6 times daily and to reduce it to 4 times daily after a week for the next 4 weeks. At 1 month, she was refracted to 20/40 N5, and the eye was quiescent. Optical coherence tomography showed that the macular was normal. The topical steroids were gradually tapered to the preoperative level. However, a month later, she returned complaining of deteriorating vision while using twice-daily steroid eyedrops. Her CDVA was 20/60. Slitlamp examination revealed anterior capsule fibrosis and capsular phimosis, resulting in partial obstruction of the visual axis and mild decentration of the IOL superior temporally (Figure 1JOURNAL/jcrs/04.03/02158034-202310000-00013/figure1/v/2023-09-28T161738Z/r/image-tiff). The anterior segment was quiescent. The pupil could only be dilated to 4.5 mm despite the absence of posterior synechiae. Fundus examination revealed a normal-looking quiescent posterior segment. Her IOP was 16 mm Hg. UBM showed a thickened anterior capsule, intact zonular fibers, and a posteriorly bowed and decentered IOL within the capsular bag (Figure 2JOURNAL/jcrs/04.03/02158034-202310000-00013/figure2/v/2023-09-28T161738Z/r/image-tiff). She was referred for further management. Discuss how you would manage this problem, explaining your decisions. How would you be able to avoid the same problem when operating on her fellow eye?

Treatment of Demodex Blepharitis: A Prospective, Randomized, Controlled, Double-Masked Clinical Trial Comparing Topical Lotilaner Ophthalmic Solution, 0.25% Eyedrops to Vehicle.

PURPOSE: To evaluate the efficacy and safety of lotilaner ophthalmic solution, 0.25% eyedrops compared to vehicle for the treatment of Demodex blepharitis. METHODS: In this randomized, controlled, double-masked clinical trial, 54 participants were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group) or the vehicle (control group) bilaterally, twice daily for 42 days. Outcome measures were collarette cure (collarette grade 0, upper eyelid), mite eradication (mite density of 0 mites/lash), and composite cure (grade 0 for collarettes and erythema). RESULTS: The proportion of participants achieving collarette cure (80.0% vs 15.8%; p < .001), mite eradication (73.3% vs 21.1%, p = .003) and composite cure (73.3% vs 10.5%, p < .001) at Day 42 was statistically significantly higher in the study group than the control group. CONCLUSION: Twice-daily 42-day treatment with novel lotilaner ophthalmic solution, 0.25% is safe and effective for the treatment of Demodex blepharitis compared to the vehicle control. (Registry number: ACTRN12620000320954, dated 09/03/2020).

Delphi Panel Consensus Regarding Current Clinical Practice Management Options for Demodex blepharitis.

Purpose: To obtain consensus on Demodex blepharitis (DB) treatment using a modified Delphi panel process. Methods: Literature search identified gaps in knowledge surrounding treatment of DB. Twelve ocular surface disease experts comprised the Demodex Expert Panel on Treatment and Eyelid Health (DEPTH). They completed a live roundtable discussion in addition to 3 surveys consisting of scaled, open-ended, true/false, and multiple-choice questions pertaining to the treatment of DB. Consensus for scaled questions using a 1 to 9 Likert scale was predefined as median scores of 7-9 and 1-3. For other question types, consensus was achieved when 8 of 12 panelists agreed. Results: The experts agreed that an effective therapeutic agent for treatment of DB would likely decrease the necessity of mechanical intervention, such as lid scrubs or blepharoexfoliation (Median = 8.5; Range 2-9). When treating DB, panelists believed that collarettes serve as a surrogate for mites, and that eliminating or reducing collarettes should be the main clinical goal of treatment (Median = 8; Range 7-9). The panelists would treat patients with at least 10 collarettes, regardless of other signs or symptoms and agreed that DB can be cured, but there is always the possibility for a reinfestation (n = 12). There was also consensus that collarettes, and therefore mites, are the primary treatment target and the way by which clinicians can monitor patient response to therapy (Median = 8; Range 7-9). Conclusion: Expert panelists achieved consensus on key facets of DB treatment. Specifically, there was consensus that collarettes are pathognomonic for DB, that DB patients with >10 collarettes should be treated even in the absence of symptoms, and that treatment efficacy can be tracked by collarette resolution. By increasing awareness about DB, understanding the goals of and monitoring treatment efficacy, patients will receive better care and, ultimately, better clinical outcomes.