Diverse Research Teams and Underrepresented Groups in Clinical Studies.

Importance: Several ophthalmic diseases disproportionately affect racial and ethnic minority patients, yet most clinical trials struggle to enroll cohorts that are demographically representative of disease burden; some barriers to recruitment include time and transportation, language and cultural differences, and fear and mistrust of research due to historical abuses. Incorporating diversity within the research team has been proposed as a method to increase trust and improve engagement among potential study participants. Objective: To examine how demographic factors of potential research participants and personnel may be associated with patient consent rates to participate in prospective ophthalmic clinical studies. Design, Setting, and Participants: This retrospective cohort study included patients from an urban, academic hospital who were approached for consent to participate in prospective ophthalmic clinical studies conducted between January 2015 and December 2021. Main Outcomes and Measures: Multivariable logistic regression assessing associations between patient and research personnel demographics and rates of affirmative consent to participate was used. Results: In total, 1380 patients (mean [SD] age, 58.6 [14.9] years; 50.3% male) who were approached for consent to participate in 10 prospective ophthalmic clinical studies were included. Of prospective patients, 566 (43.5%) were Black; 327 (25.1%), Hispanic or Latino; 373 (28.6%), White; 36 (2.8%), other race and ethnicity; and 78 (5.8%) declined to answer. Black patients (odds ratio [OR], 0.32; 95% CI, 0.24-0.44; P < .001) and Hispanic or Latino patients (OR, 0.31; 95% CI, 0.20-0.47; P < .001) were less likely to consent compared with White patients. Patients with lower socioeconomic status were less likely to consent than patients with higher socioeconomic status (OR, 0.43; 95% CI, 0.33-0.53; P < .001). Concordance between patient and research staff race and ethnicity was associated with increased odds of affirmative consent (OR, 2.72; 95% CI, 1.99-3.73; P < .001). Conclusions and Relevance: In this cohort study, patients from underrepresented racial and ethnic groups and those with lower socioeconomic status were less likely to participate in ophthalmic clinical studies. Concordance of race and ethnicity between patients and research staff was associated with improved participant enrollment. These findings underscore the importance of increasing diversity in clinical research teams to improve racial and ethnic representation in clinical studies.

Partial Stenosis and Complete Punctal Closure Following Topical Netarsudil Use for Glaucoma.

PURPOSE: To describe patients who developed partial or complete punctal closure after the use of topical netarsudil in the treatment of glaucoma, with documented reversal of symptoms on drug cessation. PATIENTS AND METHODS: This is a retrospective, single-center case series including patients treated with topical netarsudil who were documented to have developed punctal disease ipsilateral to the eye(s) being treated. A literature review was also performed to identify other similar reports. RESULTS: A total of 10 patients were included in the study. Six patients developed partial punctal stenosis and 4 patients developed complete closure of the puncta in 1 or both eye(s) ipsilateral to the use of the topical medication. None of the patients developed punctal disease on the non-netarsudil side. The time from initiation of netarsudil to the documentation of punctal disease ranged from 5-32.2 months (18.41±9.94). In the patients with complete punctal closure, discontinuation of the topical medication led to clinical reappearance of the punctal opening, ranging from 31-83 days after drug cessation (45.75±21.57). In 8 cases, discontinuation of netarsudil resulted in improved epiphora and degree of punctal stenosis on clinical examination. CONCLUSIONS: The use of topical netarsudil for glaucoma may lead to punctal stenosis and complete punctal closure. These side effects of netarsudil are relevant to therapeutic considerations for glaucoma patients.

Systemic Barriers in Receiving Electronically Prescribed Glaucoma Medications.

PRCIS: Over a third of electronically prescribed glaucoma medications were not picked up within 1 month of patient request. Feedback-driven protocols may help minimize treatment interruptions attributed to electronic prescribing. PURPOSE: Glaucoma treatment relies on long-term medication compliance and many socioeconomic factors impact the ability of patients to receive their medications. This study aims to quantify treatment interruptions attributable to electronically prescribed medications and propose interventions to minimize this barrier. METHODS: This is a cross-sectional study of the electronic prescribing patterns at a tertiary care hospital serving a socioeconomically diverse patient population. Glaucoma medication refill requests received over a 6-week interval were reviewed and patient pharmacies were contacted 1 month after the request date to determine whether the medication was received by the patient. Patients who did not pick up the prescriptions were contacted and consented to participate in a survey to identify the barriers to acquiring the medications. RESULTS: Refill requests of 198 glaucoma medications met the inclusion criteria and the most common classes were prostaglandin analogs (44%) and alpha-2-agonists (21%). Medications were not obtained within 1 month in 71 (35.9%) cases. Prior authorization requirement was significantly associated with patients not obtaining their medication (odds ratio, 0.07; 95% confidence interval, 0.03-0.45). Patient reported challenges to successful receipt electronically prescribed medications included insurance coverage (32.2%) and pharmacy availability (22.6%). CONCLUSIONS: Approximately a third of electronically prescribed glaucoma medications were not received by patients within a month of refill request due to the need for prior authorization, insurance coverage, and pharmacy availability. A mechanism to alert providers and to address these barriers to medication access may minimize treatment interruption and disease progression.

Oral Sedation is Non-Inferior to Intravenous Sedation for Cornea and Glaucoma Surgery: A Randomized Controlled Trial.

Purpose: To determine whether oral sedation is as safe and effective as IV sedation for ophthalmic surgeries other than cataract surgery, we tested whether patient satisfaction with oral triazolam was non-inferior to IV midazolam for cornea and glaucoma surgeries. Patients and Methods: Seventy-five cornea and 49 glaucoma surgery patients 18 years and older at Boston Medical Center (Boston, MA) were randomized within each study group (cornea or glaucoma) to receive oral triazolam + IV placebo, or oral placebo + IV midazolam before surgery in a double-masked fashion. Supplemental IV anesthesia was administered as needed during surgery. The primary outcome measure was patient satisfaction with anesthesia, compared between oral and IV sedation groups via t-test for non-inferiority, based on 70 cornea and 43 glaucoma subjects completing the study. Secondary outcome measures included surgeon and anesthesia provider satisfaction with anesthesia, rate of supplemental IV anesthesia, and incidence of adverse events and surgical complications. Results: Using an a priori non-inferiority margin of 0.5, initial oral sedation was non-inferior to initial IV sedation in cornea (n=70, p<0.001) and glaucoma (n=43, p=0.017) groups, even after excluding subjects administered supplemental IV anesthesia. There were no significant differences in anesthesia provider or surgeon satisfaction, intra-operative complications, adverse events, or supplemental anesthesia between groups, except for higher anesthesia provider satisfaction with oral sedation in an Ahmed or Baerveldt implant ± cataract surgery sub-group (p=0.04). Subjects receiving supplemental anesthesia included 6 oral (18.2%) and 5 IV (13.5%) in the cornea group (p=0.59), and 7 oral (29.2%) and 6 IV (31.6%) in the glaucoma group (p=0.50). Conclusion: Our results suggest that an initial dose of oral triazolam is equivalent to IV midazolam for non-cataract anterior segment surgeries. However, there was a relatively high need for supplemental IV anesthesia during some surgery types, particularly with glaucoma tube shunt implantation.

Corneal Endothelial Cell Density in Normal Tension Glaucoma Compared to Healthy Controls.

The purpose of this study was to investigate corneal endothelial cell density (ECD) and morphology between normal tension glaucoma (NTG) and controls. A cross-sectional, single center study of 24 NTG and 26 age-matched healthy eyes were included. ECD, mean cell size (MCA) and coefficient of variance (CV) were analyzed, controlling for age and number and duration of concurrent glaucoma medications. NTG subjects had significantly lower ECD (2307 ± 514.7 vs. 2558 ± 278.5, p = 0.044) and larger MCA (458.3 ± 94.8 vs. 386.7 ± 57.3, p = 0.004), but no difference in CV compared to healthy subjects. NTG subjects stratified by number of glaucoma medications showed significant differences in ECD (p = 0.024) and MCA (p = 0.021), but no difference in CV. There were no significant differences in ECD, MCA or CV between subjects stratified by duration of glaucoma medication usage. After age-adjusting, there was no dose-dependent relationship between mean ECD or MCA and number of glaucoma medications. Post hoc analysis demonstrated only NTG subjects on three or more glaucoma medications had statistically significant differences in ECD (p = 0.032) and MCA (p = 0.037) compared to NTG subjects on two glaucoma medications. This study suggests that NTG is associated with lower corneal endothelial cell density and mean cell size.

Poor Correlation of Provider and Patient Satisfaction with Anesthesia in Ophthalmic Surgeries: A Secondary Analysis of a Clinical Trial.

Purpose: This secondary analysis of a clinical trial that measured surgeon, anesthesiologist, and patient satisfaction following ophthalmic surgery under monitored anesthesia care (MAC) with a benzodiazepine investigates the degree of association between patient satisfaction with anesthesia compared to surgeon and anesthesiologist satisfaction with anesthesia. Patients and Methods: Data from analogous 6-point surgeon satisfaction surveys and anesthesiologist satisfaction surveys were compared to data from a 6-point validated patient satisfaction survey collected from a clinical trial investigating satisfaction with different forms of benzodiazepine for patients undergoing cataract, retina, cornea, or glaucoma surgery. Relationships between measures were analyzed using Pearson's correlation coefficient, with further subgroup analysis based on language groups and single-question measures of satisfaction. Results: A total of 283 ophthalmic surgical cases were analyzed. Mean surgeon satisfaction was 5.27 (range, 1.33-6.00), mean anesthesiologist satisfaction was 5.12 (range, 1.17-6.00), and mean patient satisfaction was 5.28 (range, 2.58-6.00). The correlation between surgeon and patient satisfaction was 0.333 (p = 9.06e-9), while the correlation between anesthesiologist and patient satisfaction was 0.319 (p = 4.28e-8). There was no difference between English and non-English speaking patients in correlation between surgeon and patient satisfaction (p = 0.08) and anesthesiologist and patient satisfaction (p = 0.47). Conclusion: The data demonstrate a low level of association between patient satisfaction with anesthesia and provider satisfaction, even when patient language is taken into consideration. This suggests that providers are poor predictors of patient satisfaction with anesthesia and are unreliable judges of patient comfort perioperatively.

Real-World Clinical Impact of Netarsudil 0.02% at an Urban Safety-Net Hospital.

Purpose: To analyze the efficacy, safety, and accessibility of netarsudil 0.02% in patients with glaucoma (suspect, open or closed) at a safety-net academic medical center, Boston Medical Center (BMC). Methods: Retrospective chart review of patients prescribed netarsudil 0.02% for uncontrolled glaucoma at BMC between December 2017 and September 2019. Outcome measures included change in intraocular pressure (IOP) from baseline and evaluation of adverse events (AEs). Results: One hundred thirty patients (60% severe stage) were analyzed. The IOP reduction from baseline was about 3 mmHg. Fifty-four patients (42%) experienced an AE (eg, conjunctival hyperemia). Thirty-eight patients (29%) started netarsudil 0.02% in lieu of laser or surgery. Ninety-nine patients (71%) required prior authorization for insurance coverage of netarsudil 0.02%. Ten patients (7%) were unable to obtain netarsudil 0.02% due to issues with insurance coverage. Conclusion: Netarsudil 0.02% yielded significant IOP reduction in our cohort, however, to a smaller degree compared with prior studies that bore equivocal IOP reduction regardless of baseline IOP. Conjunctival hyperemia was the most common AE. In a limited number of patients, netarsudil 0.02% was not covered by insurance.

Global Health Curricula in Ophthalmology Residency Programs in the United States.

Objective The aim of the study is to investigate the design, content, and administration of global health curricula within ophthalmology residency programs in the United States (U.S.) and share the curriculum utilized in the Department of Ophthalmology at Boston University School of Medicine (BUSM). Design A survey designed through the Association of University Professors in Ophthalmology platform was emailed to residency program directors at 106 accredited ophthalmology residency programs. Setting BUSM Department of Ophthalmology, Boston, MA. Tertiary clinical care. Participants Twenty-eight ophthalmology residency program directors responded, which represent 26% of the total number of residency programs in the United States. Twenty-seven programs fully completed the survey, and one program partially completed the survey. Results Of the respondents, three programs do not include global health curricula. The most common curricular elements included are: lectures ( n = 15, 60%); wet laboratories ( n = 10, 40%); and journal clubs ( n = 9, 36%). In terms of annual frequency, global health activities occur: twice a year ( n = 12, 46%); less than once a year ( n = 10, 39%); or every few months ( n = 4, 15%). Fewer than half of programs ( n = 10, 42%) incorporate local outreach at least once a year into their program. Twelve programs (48%) do not incorporate ethics-related topics, while the 13 remaining programs (52%) incorporate them at least once annually. The most common curricular topic is surgical techniques, with manual small incision cataract surgery (MSICS) being the most frequently emphasized ( n = 17, 68%). Conclusion A robust global health curricula combined with a hands-on international component can contribute to a well-rounded training experience. Many ophthalmology residency programs value the importance of incorporating global health into their residents' training. The most common elements of global health curricula in U.S. ophthalmology residency programs included are teaching of surgical techniques for resource-limited settings and international electives. Further investigation into the impact of different components of a global health curriculum on both resident experience and international partnerships is warranted.

Risk factors for early onset elevated intraocular pressure after pterygium surgery.

PURPOSE: In this study, we aimed to identify the risk factors for early postoperative elevation of intraocular pressure (IOP) after pterygium surgery. PATIENTS AND METHODS: All patients in this retrospective cohort study were evaluated for inclusion from a single tertiary care center at Boston Medical Center. Their pre- and postoperative IOP measurements (day 1, week 1, month 1, month 3, and when clinically necessary) were compared. Patients with postoperative IOP measurement of >22 mmHg or with an increase in IOP by ≥10 mmHg compared with the preoperative measurement value were grouped as "Ocular Hypertension" group; otherwise, patients were grouped in the "No Ocular Hypertension" group. Age, sex, race, baseline IOP, cup-to-disc (C/D) ratio, history of glaucoma, and frequency of use of postoperative steroid drops in all patients were compared. Chi square test was performed to compare the categorical variables, whereas Student's t-test was performed to compare continuous variables. We performed a multivariate logistic regression analysis of categorical data with a significance level of p < 0.05. RESULTS: In total, 240 patient charts were reviewed for inclusion in this study. Twenty-six patients required pterygium surgery on both eyes; for these patients, the eye with higher IOP was analyzed. Two patients were discontinued from this study because of elevated IOP in the contralateral, nonsurgical eye. Fortyeight out of 212 eyes (22.64%) developed postsurgical elevation of IOP within the first 3 months of operation. No significant differences were found between age, sex, baseline IOP, C/D ratio, history of glaucoma diagnoses, and frequency of use of postoperative steroid drops. However, Hispanic/Latino race (p = 0.036) and lack of application of steroid ointment (p = 0.001) were found to be the significant risk factors for the development of "Ocular Hypertension" in multivariate analysis. CONCLUSION: Early elevation of IOP is a risk of pterygium surgery. One nonmodifiable risk factor, Hispanic/Latino race, and one modifiable risk factor, lack of application of steroid ointments, were identified as potential causes of early postoperative IOP elevation.

Ptosis after glaucoma surgery.

PURPOSE: Evaluate factors contributing to ptosis after glaucoma surgery. METHODS: Three-year retrospective chart review from January 1, 2012, to January 1, 2015, 157 eyes, 3 surgeons, at Boston Medical Center, to determine the incidence of ptosis and the effects of each variable contributing to ptosis at 3 months after surgery. Each variable was analyzed using the chi-square or independent samples t-test analysis to determine statistical significance of ptosis compared with above variables. RESULTS: The t-test or chi-square analysis showed that gender, steroid duration, use of mitomycin C, duration of surgery, and prior surgeries were not statistically significant factors for ptosis. There was a statistically significant association between those <70 years of age and ptosis (P<0.05), non-combined surgery and ptosis (P<0.05), shunting surgery and ptosis (P<0.05). CONCLUSION: Ptotic changes occurred more often in those who have shunting (Ahmed and Baerveldt) surgeries compared with filtering (trabeculectomy and Express) surgeries.

Electronic medical record and glaucoma medications: connecting the medication reconciliation with adherence.

PURPOSE: To evaluate consistency in documentation of glaucoma medications in the electronic medical record and identify which regimen patients adhere to when inconsistencies exist. Factors contributing to medication nonadherence are also explored. METHODS: Retrospective chart review of medication adherence encompassing 200 patients from three glaucoma physicians at a tertiary referral center over a 1-month period. Adherence was determined by the consistency between a patients stated medication regimen and either the active medication list in the electronic medical record, or the physicians planned medication regimen in the preceding clinic visit. Patient charts were also reviewed for patient sex, age, primary language, race, and total number of medications. RESULTS: A total of 160 charts showed consistency in documentation between the physician note and electronic medication reconciliation. Of those patients, 83.1% reported adherence with their glaucoma medication schedule. When there was a discrepancy in documentation (40 charts), 72.5% patients followed the physician-stated regimen vs 20% who followed neither vs 7.5% who followed the medical record (P<0.01). No difference in adherence was observed based on sex (P=0.912) or total number of medications taken (P=0.242). Language, both English- (P=0.075) and Haitian (P=0.10) -speaking populations, as well as race, Caucasian (P=0.31), African-American (P=0.54), and Hispanic (P=0.58), had no impact on medication adherence. Patients over 80 years of age were more nonadherent as compared to other decades (P=0.04). CONCLUSION: Inconsistent documentation between the electronic medical record physician note and medication regimen may contribute to patient medication nonadherence. Patients over 80 years of age were associated with higher rates of nonadherence, while sex, total number of medications, race, and language had no interaction with medication adherence.

Practice preferences for glaucoma surgery: a survey of the American Glaucoma Society in 2008.

BACKGROUND AND OBJECTIVE: To evaluate glaucoma surgical practice patterns among members of the American Glaucoma Society (AGS). PATIENTS AND METHODS: An anonymous web-based survey was sent to AGS members to determine their preferred surgical approach in ten clinical settings. Survey results were compared with those from 1996 and 2002. RESULTS: A total of 125 (22%) AGS members responded to the survey. Mean glaucoma drainage device (GDD) usage increased from 17.5% (range: 5% to 37%; standard deviation [SD]: 10.9%) in 1996 to 50.8% (range: 15% to 76%; SD: 17.3%) in 2008, and mean trabeculectomy usage decreased from 80.8% (range: 62% to 93%; SD: 11.3%) in 1996 to 45.5% (range: 16% to 80%; SD: 17.9) in 2008. GDD was most popular in none of 8 clinical settings in 1996, and 5 of 8 clinical settings in 2008. Mitomycin C was selected as an adjunctive antifibrotic agent to trabeculectomy in 85% to 99% of cases. CONCLUSION: Glaucoma surgical practice patterns have changed since 1996. The use of a GDD has progressively increased, and the popularity of trabeculectomy decreased between 1996 and 2008. Mitomycin C remains the most frequently selected antifibrotic agent used as an adjunct to trabeculectomy.

Practice preferences for glaucoma surgery: a survey of the american glaucoma society in 2008.

BACKGROUND AND OBJECTIVE: To evaluate glaucoma surgical practice patterns among members of the American Glaucoma Society (AGS). PATIENTS AND METHODS: An anonymous web-based survey was sent to AGS members to determine their preferred surgical approach in ten clinical settings. Survey results were compared with those from 1996 and 2002. RESULTS: A total of 125 (22%) AGS members responded to the survey. Mean glaucoma drainage device (GDD) usage increased from 17.5% (range: 5% to 37%; standard deviation [SD]: 10.9%) in 1996 to 50.8% (range: 15% to 76%; SD: 17.3%) in 2008, and mean trabeculectomy usage decreased from 80.8% (range: 62% to 93%; SD: 11.3%) in 1996 to 45.5% (range: 16% to 80%; SD: 17.9) in 2008. GDD was most popular in none of 8 clinical settings in 1996, and 5 of 8 clinical settings in 2008. Mitomycin C was selected as an adjunctive antifibrotic agent to trabeculectomy in 85% to 99% of cases. CONCLUSION: Glaucoma surgical practice patterns have changed since 1996. The use of a GDD has progressively increased, and the popularity of trabeculectomy decreased between 1996 and 2008. Mitomycin C remains the most frequently selected antifibrotic agent used as an adjunct to trabeculectomy.From Boston Medical Center (MAD), Boston University School of Medicine, Boston, Massachusetts; Bascom Palmer Eye Institute (SJG, WJF, WS, RKP), University of Miami, Miller School of Medicine, Miami, Florida; and the Department of Ophthalmology (PPC), University of Washington, Seattle, Washington.The authors have no financial or proprietary interest in the materials presented herein.Address correspondence to Steven J. Gedde, MD, Bascom Palmer Eye Institute, 900 NW 17th Street, Miami, FL 33136. E-mail: sgedde@med.miami.edu Received: January 19, 2011 Accepted: March 09, 2011.

Pupillary Block Glaucoma Secondary to Phacodonesis in Pseudoexfoliation.

The authors present a clinical case of unilateral narrow angle glaucoma in the setting of pseudoexofoliation (PXF) and review the relevant literature and treatment of pseudoexfoliaton-related angle closure. They describe a case of pupillary block with secondary angle closure resulting from anterior subluxation of the lens arising secondary to zonular weakness related to PXF. This mechanism is demonstrated with slit lamp exam and anterior segment ultrasound biomicroscopy (UBM). This case helps to document and better characterize the occurrence of narrow angles and angle closure glaucoma arising in PXF, an entity that is not well documented in the literature. The case also illustrates the need for periodic gonioscopy and examination of anterior chamber depth to evaluate for prophylactic peripheral laser iridotomy to prevent angle closure glaucoma in patients with PXF.

Corneal melt associated with idiopathic dacryoadenitis.

A 15-year-old boy presented with left-sided ptosis, upper eyelid swelling, proptosis, conjunctivitis, and a central corneal epithelial defect with thinning. MRI demonstrated an enhancing orbital mass associated with the lacrimal gland. Biopsy findings were consistent with orbital inflammatory syndrome. Topical cyclosporine and 1% methylprednisolone eliminated the anterior segment inflammation; subsequent treatment with systemic prednisone reduced the ptosis and edema. To our knowledge, this is the only reported case of orbital inflammatory syndrome associated with a corneal epithelial defect and thinning.