Radial keratotomy and cataract surgery: A quest for emmetropia.

A 75-year-old man with an ocular history of 8-cut radial keratotomy (RK) in both eyes presented for cataract surgery evaluation. He was previously correctable in spectacles in years prior despite his irregular corneas to 20/25 in the right eye and 20/30 in the left eye. He recently noticed a change in his overall visual function with significant nighttime glare and difficulty reading despite spectacle correction. Of note, he was unable to tolerate contact lenses and was resistant to refitting despite additional encouragement. Cataract surgery was delayed for many years, given he was correctable in spectacles and the concern of uncovering a highly aberrated cornea after removing his cataracts (Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202308000-00021/figure1/v/2023-07-21T030437Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202308000-00021/figure2/v/2023-07-21T030437Z/r/image-tiff). Of note, the patient was interested in returning to the spectacle independence he enjoyed in the past. Ocular examination revealed a corrected distance visual acuity (CDVA) of 20/30 in the right eye and 20/60 in the left eye, with a manifest refraction of +4.50 -0.50 × 177 in the right eye and +5.75 -1.75 × 14 in the left eye. Glare testing was 20/50 in the right eye and 20/100 in the left eye, with retinal acuity meter testing of 20/25 in each eye. Pupils, confrontation visual fields, and intraocular pressures were normal. Pertinent slitlamp examination revealed corneal findings of 8-cut RK with nasal-gaping arcuate incisions in both eyes and lens findings of 2+ nuclear sclerosis with 2+ cortical changes in the right eye and 3+ nuclear sclerosis with 3+ cortical changes in the left eye. Cup-to-disc ratios of the optic nerves measured 0.5 with temporal sloping in the right eye and 0.6 with temporal sloping in the left eye. The dilated fundus examination was unremarkable. What intraocular lens (IOL) options would you offer this patient and how would you counsel regarding realistic expectations? What additional diagnostic testing would be helpful in your assessment? How would you calculate the IOLs?

Optimized Artificial Intelligence for Enhanced Ectasia Detection Using Scheimpflug-Based Corneal Tomography and Biomechanical Data.

PURPOSE: To optimize artificial intelligence (AI) algorithms to integrate Scheimpflug-based corneal tomography and biomechanics to enhance ectasia detection. DESIGN: Multicenter cross-sectional case-control retrospective study. METHODS: A total of 3886 unoperated eyes from 3412 patients had Pentacam and Corvis ST (Oculus Optikgeräte GmbH) examinations. The database included 1 eye randomly selected from 1680 normal patients (N) and from 1181 "bilateral" keratoconus (KC) patients, along with 551 normal topography eyes from patients with very asymmetric ectasia (VAE-NT), and their 474 unoperated ectatic (VAE-E) eyes. The current TBIv1 (tomographic-biomechanical index) was tested, and an optimized AI algorithm was developed for augmenting accuracy. RESULTS: The area under the receiver operating characteristic curve (AUC) of the TBIv1 for discriminating clinical ectasia (KC and VAE-E) was 0.999 (98.5% sensitivity; 98.6% specificity [cutoff: 0.5]), and for VAE-NT, 0.899 (76% sensitivity; 89.1% specificity [cutoff: 0.29]). A novel random forest algorithm (TBIv2), developed with 18 features in 156 trees using 10-fold cross-validation, had a significantly higher AUC (0.945; DeLong, P < .0001) for detecting VAE-NT (84.4% sensitivity and 90.1% specificity; cutoff: 0.43; DeLong, P < .0001) and a similar AUC for clinical ectasia (0.999; DeLong, P = .818; 98.7% sensitivity; 99.2% specificity [cutoff: 0.8]). Considering all cases, the TBIv2 had a higher AUC (0.985) than TBIv1 (0.974; DeLong, P < .0001). CONCLUSIONS: AI optimization to integrate Scheimpflug-based corneal tomography and biomechanical assessments augments accuracy for ectasia detection, characterizing ectasia susceptibility in the diverse VAE-NT group. Some patients with VAE may have true unilateral ectasia. Machine learning considering additional data, including epithelial thickness or other parameters from multimodal refractive imaging, will continuously enhance accuracy. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.

The Prevalence of Demodex Blepharitis in US Eye Care Clinic Patients as Determined by Collarettes: A Pathognomonic Sign.

Purpose: To evaluate the prevalence of Demodex blepharitis by its pathognomonic sign, collarettes, in patients presenting for any reason to eye care clinics in the United States. Patients and Methods: In this retrospective study by 7 investigators at 6 eye care clinics, case records of consecutive patients who underwent a slit-lamp examination, regardless of chief complaint, were reviewed for Demodex blepharitis, as identified by the presence of collarettes. Patient characteristics, including age, gender, race, relevant ocular and systemic diagnoses, ocular medications, lid hygiene practices and contact lens wear, were also recorded. Results: Of 1032 patients (mean age: 60.2 ± 17.8 years), 57.7% had Demodex blepharitis. While the prevalence of Demodex blepharitis in patients with dry eye disease (DED) (58.9%) and cataract (55.7%) was similar to the overall prevalence of Demodex blepharitis, it was higher in patients with blepharitis (69.1%) and glaucoma (64.8%). Among patients with collarettes, 44.0% had never been diagnosed with blepharitis. Among those on anti-inflammatory DED treatment, 60.0% had Demodex blepharitis. Demodex blepharitis prevalence was significantly higher among those using topical tea tree oil versus those who were not (74.5% versus 56.7% p = 0.014); prevalence was comparable among those using/not using lid wipes (56.9% versus 55.5%). Conclusion: Demodex blepharitis, based on the pathognomonic finding of collarettes, is common and likely underdiagnosed among patients seeking eye care. These collarettes are still found in patients using over-the-counter treatments for blepharitis. The present study highlights the importance of screening patients for collarettes and Demodex blepharitis as part of every slit-lamp examination.

Classification of Presbyopia by Severity.

There are close to two billion individuals globally living with presbyopia. In spite of its ubiquitous and progressive nature, there is no widely accepted, formal guideline or consensus statement on the classification of presbyopia by degree of severity. A panel of leading eye care professionals representing both optometrists and ophthalmologists convened virtually to discuss and document their combined assessments from the body of literature and clinical practice expertise in this commentary. In light of emerging therapies, classifying presbyopia by mild, moderate, or advanced severity may help provide consistency of diagnosis among eye care providers and may aid in managing patient expectations with different treatment options.

Meibomian Gland Dysfunction: A Dermatological Perspective on Pathogenesis and Treatment Outlook.

Meibomian glands are modified oil-producing glands that produce meibum and can become dysfunctional and negatively affect the lipid layer in the tear film, resulting in ocular surface diseases such as evaporative dry eye. Abnormal keratin production and aggregation at the meibomian gland orifice has been implicated in the pathogenesis of meibomian gland dysfunction (MGD). Current treatments largely ignore the role of keratin proteins. This review paper synthesizes various publications on hyperkeratinization and its role in MGD pathogenesis and proposes a novel treatment strategy for MGD that involves the use of keratolytic agents commonly used in dermatological treatments.

The Relationship Between Dry Eye Disease and Digital Screen Use.

Dry eye disease is characterized by tear film instability that can result in ocular surface damage. Patients with dry eye disease may experience ocular pain/discomfort and visual disturbances that may negatively impact quality of life. Increased use of digital screens for work, communication, and entertainment, especially during times of pandemic, may contribute to dry eye. Extensive cross-sectional studies have shown that digital screen use duration is associated with an increased risk of severe symptoms and clinical diagnosis of dry eye disease in adults. Smartphone use duration has also been found to be greater in school-age children with dry eye disease than in those without dry eye disease. A commonly accepted hypothesis for the relationship between digital screen use and dry eye disease is that digital screen use changes blinking dynamics, leading to ocular dryness. This review describes evidence that digital screen use is associated with dry eye disease, that digital device use alters blinking dynamics, and that dry eye affects mental health and work productivity in digital screen users. Helpful prevention and management strategies for dry eye disease exist for those who use digital screens.

Dry Eye Treatment with Topical Cyclosporine 0.1% in Chondroitin Sulfate Ophthalmic Emulsion.

PURPOSE: To evaluate the efficacy of topical cyclosporine 0.1% in chondroitin sulfate emulsion for the treatment of dry eye. METHODS: This retrospective multicenter study included 100 eyes of 50 dry eye patients aged ≥18 years, with preoperative ocular surface disease index (OSDI) score >12 or corneal staining grade >1 (in either eye) who underwent dry eye treatment with topical cyclosporine 0.1% in chondroitin sulfate emulsion (Klarity-C, ImprimisRx) for 3 months. Postoperative evaluation included comparison of the changes in OSDI score and corneal staining grade after 3 months of treatment from baseline. RESULTS: From baseline to 3 months, a statistically significant improvement in mean OSDI scores (38.19 vs 24.18, p <0.001) as well as mean corneal staining grade (3.62 vs 2.20, p <0.001) was observed. The proportion of subjects with severe dry eye decreased from 62% to 20% and more than one-third (34%) of patients were in the normal OSDI range. The percentage of eyes with corneal staining grade of 2 or 3 decreased from 21% (baseline) to 8% at 3 months; 50% of the eyes had corneal staining grade of 0. The treatment was found to be safe with no adverse events observed in the study. CONCLUSION: Dry eye treatment with twice daily cyclosporine 0.1% in chondroitin sulfate emulsion was found to be safe and effective in reducing signs and symptoms of dry eye.

Detection of postlaser vision correction ectasia with a new combined biomechanical index.

PURPOSE: To validate and evaluate the use of a new biomechanical index known as the Corvis biomechanical index-laser vision correction (CBI-LVC) as a method for separating stable post-LVC eyes from post-LVC eyes with ectasia. SETTING: 10 clinics from 9 countries. DESIGN: Retrospective, multicenter, clinical study. METHODS: The study was designed with 2 purposes: to develop the CBI-LVC, which combines dynamic corneal response (DCR) parameters provided by a high-speed dynamic Scheimpflug camera (CorVis ST; OCULUS Optikgeräte GmbH) and then to evaluate its ability to detect post-LVC ectasia. The CBI-LVC includes integrated inverse radius, applanation 1 (A1) velocity, A1 deflection amplitude, highest concavity and arclength, deformation amplitude ratio of 2 mm, and A1 arclength in millimeters. Logistic regression with Wald forward stepwise approach was used to identify the optimal combination of DCRs to create the CBI-LVC and then separate stable from LVC-induced ectasia. Eighty percentage of the database was used for training the software and 20% for validation. RESULTS: 736 eyes of 736 patients were included (685 stable LVC and 51 post-LVC ectasia). The receiver operating characteristic curve analysis showed an area under the curve of 0.991 when applying CBI-LVC in the validation dataset and 0.998 in the training dataset. A cutoff of 0.2 was able to separate stable LVC from ectasia with a sensitivity of 93.3% and a specificity of 97.8%. CONCLUSIONS: The CBI-LVC was highly sensitive and specific in distinguishing stable from ectatic post-LVC eyes. Using CBI-LVC in routine practice, along with topography and tomography, can aid the early diagnosis of post-LVC ectasia and allow intervention prior to visually compromising progression.

Corneal crosslinking without epithelial removal.

PURPOSE: To evaluate the effect of riboflavin-ultraviolet (UV)-A corneal crosslinking (CXL) without epithelial removal on ectatic corneal disease. SETTING: Woolfson Eye Institute, Atlanta, Georgia, USA. DESIGN: Prospective observational study. METHODS: Patients were treated with a new riboflavin formulation without epithelial removal, then exposed to UV light (365 nm) at 4 mW/cm2 with on-off cycling for 30 minutes. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, maximum corneal curvature (maximum keratometry [Kmax]), total higher-order aberrations (HOAs), and coma were measured at 3, 6, 12, and 24 months postoperatively. Progression was defined as an increase of more than 1 diopter (D) in Kmax and loss of more than 1 line of CDVA. RESULTS: Five hundred twelve eyes of 308 patients with keratoconus or forme fruste keratoconus and 80 eyes of 55 patients with ectasia after laser in situ keratomileusis (LASIK) were treated with the new riboflavin formulation without epithelial removal; 229 patients received bilateral treatments, 95 of which were simultaneous. The mean UDVA and CDVA improved by 1 to 1.5 Snellen lines at 1 and 2 years postoperatively (P < .0001). Mean Kmax decreased by 0.48 D at 2 years postoperatively (P = .0002). Mean total HOAs and coma decreased by 36% (P < .0001) and 37% (P = .0002), respectively, at 2 years postoperatively. Kmax decreased more than 1 D in three times as many eyes as it increased more than 1 D (P < .0001). No eyes progressed, and there was no loss of effect between 1 and 2 years postoperatively. No vision-threatening events were observed. Pain typically resolved within 24 hours, and visual acuity returned to preoperative levels in 1 to 2 days. CONCLUSION: Epithelium-on CXL using this new protocol halted the progression of keratoconus and ectasia after LASIK. It was safer and provided more rapid visual recovery than CXL with epithelial removal, allowing routine bilateral, simultaneous treatment.

Evaluation of a new artificial tear formulation for the management of tear film stability and visual function in patients with dry eye.

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.

The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye.

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.

Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study.

INTRODUCTION: Bromfenac is a well-known topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) that is commercialized in the USA and other regions of the world. A new formulation, 0.075% bromfenac in DuraSite®, was developed to treat postoperative inflammation and reduce pain in patients who have undergone cataract surgery. We hypothesized that efficacy and safety would be enhanced with twice-daily (BID) dosing compared to once-daily (QD) dosing. METHODS: This was a multicenter, double-masked, comparative study in which 40 and 45 subjects were randomized to groups receiving BID dosing and QD dosing, respectively. Subjects self-instilled the study drug for 14 days postoperative and were followed for an additional 2-week evaluation phase. The primary efficacy endpoint was the proportion of subjects with an anterior chamber cell (ACC) grade of 0 at day 15. RESULTS: A total of 45 subjects had cleared ACC (grade "0") at day 15, of whom 21 were in the BID group (52.5%) and 24 were in the QD group (53.5%). A secondary analysis found 7/40 (17.5%) subjects in the BID group and 10/45 (22.2%) subjects in the QD group achieved an ACC grade of 0 at day 8. There were more adverse events in the QD group (n = 16) than in the BID group (n = 12). CONCLUSION: Similar outcomes were observed for subjects using Bromfenac 0.075% in DuraSite® in the BID and QD dosing regimens for the treatment of post-cataract surgery inflammation. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01190878. FUNDING: InSite Vision (now a division of Sun Pharma).

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.

Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.

PURPOSE: To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery. SETTING: Twenty centers in the United States and the Netherlands. DESIGN: Prospective randomized clinical trials. METHODS: Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted. RESULTS: The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. CONCLUSION: In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain. FINANCIAL DISCLOSURE: Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned.

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial keratitis: a retrospective safety surveillance study.

PURPOSE: The objective of this study was to collect and evaluate retrospective safety information about the use of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial keratitis. METHODS: This was a retrospective, postmarketing surveillance study conducted at 10 clinical centers in the United States. The study population included 142 patients treated with besifloxacin ophthalmic suspension 0.6% for bacterial keratitis in one or both eyes. For perspective, data on 85 patients treated at these centers with moxifloxacin ophthalmic solution 0.5% for bacterial keratitis were also included. The analysis was designed to measure the types and rates of adverse events (AEs) reported during the treatment of bacterial keratitis with besifloxacin ophthalmic suspension 0.6%. Other treatment outcomes of interest included the development of corneal scarring and corneal neovascularization, measured or presumed bacterial eradication, ending visual acuity, and duration of pain before and after treatment. RESULTS: There was one reported AE of mild superficial punctate keratitis in a patient using besifloxacin ophthalmic suspension 0.6%. The difference in AE frequencies between groups was not significant (P>0.999). Additional treatment outcomes were similar for both groups. Limitations of this report include the retrospective nature of the study. CONCLUSIONS: These retrospective data suggest that besifloxacin ophthalmic suspension 0.6% was well tolerated when included in the treatment of bacterial keratitis; no serious AEs were reported. A prospective clinical trial is needed to better isolate the contribution of besifloxacin to the therapeutic outcome and to confirm these observations.