The relationship between intraocular pressure and glaucoma: An evolving concept.

Intraocular pressure (IOP) is the most important modifiable risk factor for glaucoma and fluctuates considerably within patients over short and long time periods. Our field's understanding of IOP has evolved considerably in recent years, driven by tonometric technologies with increasing accuracy, reproducibility, and temporal resolution that have refined our knowledge regarding the relationship between IOP and glaucoma risk and pathogenesis. The goal of this article is to review the published literature pertinent to the following points: 1) the factors that determine IOP in physiologic and pathologic states; 2) technologies for measuring IOP; 3) scientific and clinical rationale for measuring diverse IOP metrics in patients with glaucoma; 4) the impact and shortcomings of current standard-of-care IOP monitoring approaches; 5) recommendations for approaches to IOP monitoring that could improve patient outcomes; and 6) research questions that must be answered to improve our understanding of how IOP contributes to disease progression. Retrospective and prospective data, including that from landmark clinical trials, document greater IOP fluctuations in glaucomatous than healthy eyes, tendencies for maximal daily IOP to occur outside of office hours, and, in addition to mean and maximal IOP, an association between IOP fluctuation and glaucoma progression that is independent of mean in-office IOP. Ambulatory IOP monitoring, measuring IOP outside of office hours and at different times of day and night, provides clinicians with discrete data that could improve patient outcomes. Eye care clinicians treating glaucoma based on isolated in-office IOP measurements may make treatment decisions without fully capturing the entire IOP profile of an individual. Data linking home blood pressure monitors and home glucose sensors to dramatically improved outcomes for patients with systemic hypertension and diabetes and will be reviewed as they pertain to the question of whether ambulatory tonometry is positioned to do the same for glaucoma management. Prospective randomized controlled studies are warranted to determine whether remote tonometry-based glaucoma management might reduce vision loss and improve patient outcomes.

COVID-19-associated rhino-orbito-cerebral mucormycosis: a single center prospective study of 264 patients.

PURPOSE: Outbreaks of mucormycosis were reported worldwide throughout the COVID-19 pandemic. We report clinical outcomes of a treatment protocol for COVID-19-associated rhino-orbital-cerebral mucormycosis (ROCM). METHODS: Patients with biopsy-proven mucormycosis and COVID-19 were included. All received intravenous amphotericin B deoxycholate 1 mg/kg and surgical endoscopic sinus debridement (FESS). Those with rhino-orbital or cerebral disease limited to the cavernous sinus were eligible for transcutaneous retrobulbar amphotericin B (TRAMB). Patients were followed with weekly imaging, endoscopic examinations, and serial debridement as necessary. Patients were discharged on oral posaconazole for 6 months. RESULTS: In total, 264 patients were followed for a mean of 2.5 months. On presentation, 163 patients (174 eyes) had eye involvement. Of these, 141 eyes (81.0%) had light perception or worse vision. By the last follow-up, 163 patients (176 eyes) were affected, and of these, 96 eyes (54.5%) had no light perception. Twenty-one patients (8%) died and 3 orbits (0.5%) were exenterated. There was no change in mortality (p = 0.38) or exenteration (p = 0.38) in the 55 patients who received TRAMB compared to patients with rhino-orbital or cerebral disease limited to the cavernous sinus who did not. Asymptomatic COVID-19 was associated with higher mortality than symptomatic COVID-19 (p = 0.025). Uncontrolled diabetes was a risk factor for death (p = 0.022). New diabetes was associated with increased mortality versus pre-existing diabetes (p = 0.005). CONCLUSION: A multidisciplinary approach is crucial to manage COVID-19-ROCM. In our cohort, TRAMB therapy did not increase mortality or exenteration rates. While poor vision on presentation was profound, some vision recovery was noted with treatment. COVID-19 immune dysregulation may predispose patients to ROCM, particularly those with asymptomatic disease.

Reusing surgical materials for cataract surgery: an assessment of potential contamination.

PURPOSE: To evaluate microbiological cultures of cataract surgical devices and products that were reused for multiple cases. SETTING: Aravind Eye Hospital, Pondicherry, Tamil Nadu, India. DESIGN: Prospective cohort study. METHODS: Samples from multiple surgical instruments and products that were reused for consecutive cataract surgeries underwent bacterial and fungal cultures and were monitored alongside positive controls for 7 days. This included instruments that were processed using immediate use steam sterilization (IUSS) between cases (eg, surgical cannulas, syringes, phacoemulsification and coaxial/bimanual irrigation/aspiration [I/A] tips, phacoemulsification and I/A sleeves) (Group 1), instruments that were used without sterilization between cases (eg, phacoemulsification tubing/handpieces, coaxial I/A handpieces) (Group 2), and the residual (unused) fluid from balanced salt solution bags after being used for multiple patients (Group 3). RESULTS: 3333 discrete samples were collected from all 3 product groups that were reused across multiple patients. In all collected samples, no bacterial or fungal growth was observed. Of the 3241 cataract surgeries that used reused and IUSS-sterilized instruments alongside instrument sets cultured on the same day and balanced salt solution bags shared across multiple patients, no eyes developed endophthalmitis over a 6-week follow-up period. CONCLUSIONS: Bacterial or fungal growth was not found in extensive microbiological cultures of IUSS-sterilized ophthalmic surgical instruments and cataract surgical products that were reused in multiple patients. This microbiological data complements clinical endophthalmitis data from 2 million consecutive cases at the Aravind Eye Hospital, suggesting that their instrument and surgical supply processing practices may allow for safe and sustainable ophthalmic care.

Ocular Pharmacology.

Treatment of ocular diseases presents unique challenges and opportunities for the clinician and for the clinical pharmacologist. Ophthalmic pharmaceuticals, typically given as liquids, require consideration of solubility, physiological pH, and osmolarity, as well as sterility and stability, which in turn requires optimal pharmaceutics. Ocular tissue levels are challenging to obtain in humans, and the clinical pharmacokinetics is typically blood levels, which are primarily related to safety, rather than efficacy. The eye is a closed compartment with multiple physiological barriers with esterases and transporters, but relatively little cytochrome oxidases. Delivery routes include topical, intravitreal, and systemic. Patient dosing involves not only adherence issues common to all chronic diseases, but also performance requirements on eye drop instillation. Therapeutically, ocular diseases and their pharmacological treatments include both those analogous to systemic diseases (e.g., inflammation, infection, and neuronal degeneration) and those unique to the eye (e.g., cataract and myopia).

An Evaluation of the Efficacy and Safety of Timolol Maleate 0.5% Microdrops Administered with the Nanodropper.

PURPOSE: To examine if 12.5 µl timolol maleate 0.5% microdrops dispensed with the Nanodropper Adaptor provide noninferior intraocular pressure (IOP) reduction compared with conventional 28 µl drops in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). DESIGN: Prospective, noninferiority, parallel, multicenter, single-masked, active-controlled, randomized trial. PARTICIPANTS: Treatment-naïve subjects who were recently diagnosed with OAG and OHT at the Aravind Eye Care System. METHODS: Both eyes of subjects received 1 commercially available drop or both eyes of subjects received 1 microdrop of timolol maleate 0.5%. We measured IOP, resting heart rate (HR), and blood pressure (BP) at baseline and 1, 2, 5, and 8 hours after timolol administration. MAIN OUTCOME MEASURES: The IOP was the primary outcome measure. Secondary outcomes were resting HR, systolic BP (sBP), and diastolic BP (dBP). RESULTS: Adaptor-mediated microdrops and conventional drops of timolol significantly decreased IOP compared with baseline at all timepoints. Noninferiority was established at 3 of 4 timepoints. Heart rate decreases with Nanodropper were approximately 3 beats per minute (bpm) less than with conventional drops. CONCLUSIONS: Timolol microdrops appear to be as effective in ocular hypotensive action as conventional drops with a slightly attenuated effect on resting HR and BP. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

African American patient-provider communication about glaucoma vision quality-of-life.

BACKGROUND/OBJECTIVES: Little is known about African American patient-provider communication about glaucoma-related quality-of-life. The objectives of this study were to: (a) examine associations between patient socio-demographics and vision quality-of-life, (b) describe the extent to which eye care providers and patients discuss glaucoma-related quality-of-life, and (c) examine associations between patient and provider characteristics, whether the patient was in the intervention or usual care group, and whether the patient and provider discuss one or more glaucoma-related quality-of-life domains. METHODS: Adult African American patients with glaucoma who reported non-adherence to glaucoma medications were enrolled from three sites. Patients completed a vision quality-of-life VFQ-25 assessment. Patients were randomized into intervention and control groups with intervention group members receiving a glaucoma question prompt list and watching a video before a provider visit. Audio recordings from these visits were transcribed and assessed for glaucoma-related quality-of-life discussions. RESULTS: One hundred and eighty-nine patients were enrolled. Glaucoma-related quality-of-life was discussed during 12.3% of visits (N = 23). Patients initiated discussion 56.5% (N = 13) of the time and providers 43.5% (N = 10) of the time. Patients with worse health literacy (p < 0.001), more depressive symptoms (p < 0.05), and more severe glaucoma (p < 0.001) were significantly more likely to have worse vision-related quality-of-life. Glaucoma-related quality-of-life was significantly more likely to be discussed when African American patients saw African American providers (p < 0.05). CONCLUSION: Patients and providers rarely discussed the patient's glaucoma-related quality-of-life. The intervention did not significantly increase communication about glaucoma-related quality-of-life. Residency programs should consider enhancing training regarding discussing patients' quality-of-life.

Do African American patients with glaucoma ask their eye providers the questions they have?

PURPOSE: The objective of this study was to describe what questions patients checked on a glaucoma question prompt list and how often patients asked the same checked questions during medical visits. DESIGN: A randomized controlled trial was conducted to test the effectiveness of a pre-visit video/glaucoma question prompt list intervention to increase African American patient question-asking during medical visits. METHODS: Adult African American patients with glaucoma and a history of non-adherence to glaucoma medications were enrolled and randomized into intervention and usual care groups from three glaucoma practices. Visits were audio-recorded, transcribed, and coded for the questions patients asked during their visits. Researchers collected the pre-visit question prompt lists from the intervention group and compared their checked questions to the questions patients asked during their visit. RESULTS: Ninety-three subjects were randomized to the question prompt list intervention group. Subjects checked an average of 6.77 questions on the prompt list. Of the subjects who checked at least one question, 54.8% asked their provider at least one of the questions they checked. The most common questions asked about glaucoma medications that they had checked were "What time(s) of day should I take my drops?" (50.0%, 9 out of 18) and "How many times a day do I use my glaucoma medicines?" (50.0%, 3 out of 6). CONCLUSION: Although African American subjects with glaucoma have questions about glaucoma and their medications, few asked all their questions during visits. Future research should focus on how to improve question asking using a question prompt list.

A Previsit Intervention's Influence on Glaucoma Topics Discussed between Black Patients and Providers.

PURPOSE: The objectives of this study were to conduct a randomized controlled trial testing the effectiveness of a previsit glaucoma video/question prompt list intervention, and to examine the impact on how often providers educate Black patients about glaucoma and glaucoma medication topics during visits. DESIGN: A randomized controlled trial of a glaucoma question prompt list/video intervention. PARTICIPANTS: Black patients with a diagnosis of glaucoma who are taking 1 or more glaucoma medications and report being nonadherent. METHODS: One hundred eighty-nine Black patients with glaucoma were enrolled and assigned to either a usual care or an intervention group where they watched a video emphasizing the importance of asking questions and received a glaucoma question prompt list to complete before clinic visits. Visits were audio-taped and patients were interviewed after visits. MAIN OUTCOME MEASURES: Whether the provider educates about different glaucoma and glaucoma medication topics. RESULTS: Patients in the intervention group were significantly more likely to ask providers 1 or more questions about glaucoma and its treatment. Providers were significantly more likely to educate intervention patients about their diagnosis (P = 0.001), intraocular pressure (P = 0.03), the likelihood of the need for long-term therapy (P = 0.001), and the physical changes associated with glaucoma (P = 0.001) than usual-care patients. Providers were also significantly more likely to educate intervention patients about the purpose of their medications (P = 0.03) and side effects (P = 0.001) than usual-care patients. Providers only educated 29% of patients about adherence (33% of intervention group patients and 25% of usual-care patients). Few providers educated patients about barriers and fears/concerns in using glaucoma medications, the cost of medications and insurance coverage, how to administer eye drops, and nasolacrimal occlusion. CONCLUSIONS: The intervention significantly increased provider education about many glaucoma and glaucoma medication topics. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Improving Black Patient Question-Asking and Provider Education During Glaucoma Visits.

PURPOSE: The objectives of this study were to conduct a randomized, controlled trial testing the effectiveness of a previsit glaucoma video/question prompt list intervention to increase Black patient question-asking and provider education about glaucoma and glaucoma medications during visits. DESIGN: A randomized, controlled trial of a glaucoma question prompt list/video intervention. PARTICIPANTS: Black patients with a glaucoma diagnosis who were currently taking 1 or more glaucoma medications and reported being nonadherent. METHODS: One hundred and eighty-nine Black patients with glaucoma were enrolled into a randomized, controlled trial and assigned to either a usual care or an intervention group where they watched a video emphasizing the importance of asking questions and received a glaucoma question prompt list to complete before clinic visits. Visits were audiotaped and patients were interviewed after visits. MAIN OUTCOME MEASURES: Outcome measures were if the patient asked 1 or more questions about glaucoma and glaucoma medications and the number of glaucoma and glaucoma medication areas the provider educated the patient about during the visit. RESULTS: Patients in the intervention group were significantly more likely to ask 1 or more questions about glaucoma than patients in the usual care group (odds ratio, 5.4; 95% confidence interval [CI], 2.8-10.4). Patients in the intervention group were significantly more likely to ask 1 or more questions about glaucoma medications than patients in the usual care group (odds ratio, 2.8; 95% CI, 1.5-5.4). Patients in the intervention group were significantly more likely to receive more areas of education about glaucoma from their providers during visits (ß = 0.94; 95% CI, 0.49-1.4). Patients who asked 1 or more questions about glaucoma medications were significantly more likely to receive more areas of education about glaucoma medications from providers (ß = 1.8; 95% CI, 1.2-2.5). CONCLUSIONS: The intervention increased patient question-asking about glaucoma and glaucoma medications and provider education about glaucoma. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Provider use of a participatory decision-making style with African American patients with glaucoma.

OBJECTIVE: To examine whether non-adherent African American patients with glaucoma who received a question prompt list and video intervention were more likely to be given treatment options, have their input included into treatment regimens, and rate their providers as using more of a participatory decision-making style. METHODS: African American patients with glaucoma taking one or more glaucoma medications and reported being non-adherent were randomized to a pre-visit video and glaucoma question prompt list intervention or usual care. RESULTS: 189 African American patients with glaucoma participated. Providers gave patients treatment choices during 5.3% of visits and included patient input into treatment regimen decisions during 2.1% of visits. Male patients and patients with more years of education were significantly more likely to rate their providers as using more of a participatory decision-making style. CONCLUSION: African American patients with glaucoma rated their providers high on using a participatory decision-making style. Yet, providers infrequently presented non-adherent patients with medication treatment options, and it was rare for providers to include patient input into treatment decisions. PRACTICE IMPLICATIONS: Providers should provide non-adherent patients with different glaucoma treatment options. Non-adherent African American patients with glaucoma should be encouraged to ask their providers for different medication treatment options.

Changing operating room practices: the effect on postoperative endophthalmitis rates following cataract surgery.

PURPOSE: To determine whether four new operating room (OR) protocols instituted because of COVID-19 reduced the cataract surgical postoperative endophthalmitis rate (POE). DESIGN: Retrospective, sequential, clinical registry study. METHODS: 85 552 sequential patients undergoing cataract surgery at the Aravind Eye Hospitals between 1 January 2020 and 25 March 2020 (56 551 in group 1) and 3 May 2020 and 31 August 2020 (29 011 in group 2). In group 1, patients were not gowned, surgical gloves were disinfected but not changed between cases, OR floors were not cleaned between every case, and multiple patients underwent preparation and surgery in the same OR. In group 2, each patient was gowned, surgical gloves were changed between each case, OR floors and counters were cleaned between patients, and only one patient at a time underwent preparation and surgery in the OR. RESULTS: Group 1 was older, had slightly more females, and better preoperative vision. More eyes in group 2 underwent phacoemulsification (p=0.18). Three eyes (0.005%) in group 1 and 2 eyes (0.006%) in group 2 developed POE (p=0.77). Only one eye that underwent phacoemulsification developed POE; this was in group 1. There was no difference in posterior capsule rupture rate between the two groups. CONCLUSIONS: Adopting a set of four temporary OR protocols that are often mandatory in the Western world did not reduce the POE rate. Along with previously published studies, these results challenge the necessity of these common practices which may be needlessly costly and wasteful, arguing for the reevaluation of empiric and potentially unnecessary guidelines that govern ophthalmic surgeries.

Reducing topical drug waste in ophthalmic surgery: multisociety position paper.

This position article on reducing topical drug waste with ophthalmic surgery was written by the Ophthalmic Instrument Cleaning and Sterilization Task Force, comprising representatives of the ASCRS, American Academy of Ophthalmology, American Glaucoma Society, and Outpatient Ophthalmic Surgery Society. Drug waste significantly increases the costs and carbon footprint of ophthalmic surgery. Surgical facilities should be permitted to use topical drugs in multidose containers on multiple patients until the manufacturer's labeled date of expiration, if proper guidelines are followed. Surgical patients requiring a topical medication not used for other patients should be allowed to bring that partially used medication home for postoperative use. These recommendations are based on published evidence and clarification of policies from multiple regulatory and accrediting agencies with jurisdiction over surgical facilities. Surveys suggest that most ambulatory surgery centers and hospitals performing cataract surgery are wasting topical drugs unnecessarily.

Acceptance of a Pre-visit Intervention to Engage African American Glaucoma Patients during Visits.

SIGNIFICANCE: The glaucoma question prompt list/video intervention was well received by patients. Eighty-seven percent of patients recommended that other patients should watch the educational video before their visits, and 89% said that other patients should complete the question prompt list before visits. PURPOSE: The objectives of this study were to (a) describe patient feedback on a glaucoma question prompt list/video intervention designed to motivate African American patients to be more engaged during visits and (b) examine patient demographics associated with acceptance of the intervention. METHODS: We are conducting a randomized controlled trial of a glaucoma question prompt list/video intervention. African American patients with glaucoma were enrolled and assigned to a control group or an intervention group where they watched a video emphasizing the importance of asking questions and received a prompt list to complete before visits. All patients were interviewed after visits and are being followed up for 12 months. RESULTS: One hundred eighty-nine African American patients with glaucoma were enrolled into the larger trial. Of the 93 patients randomized to the intervention group, 89% said that patients should complete the prompt lists before visits, and 87% recommended that patients should watch the video before visits. Older patients were significantly less likely to believe that other patients should watch the video before their visits (t = -3.7, P = .04). Patients with fewer years of education were significantly more likely to rate the video as being more useful than patients with more years of education (Pearson correlation, -0.27; P = .01). Patients who reported being less adherent on the visual analog scale were more likely to rate the video as being more useful (Pearson correlation, -0.23; P = .03). CONCLUSIONS: This study demonstrates that the question prompt list/video was accepted by the majority of African American patients who received the intervention.

The Impact of COVID-19 on Individuals Across the Spectrum of Visual Impairment.

PURPOSE: TO assess perceptions and implications of COVID-19 infection across the spectrum of individuals with visually impairment (VI) and those with normal sight. DESIGN: Prospective cross-sectional comparative study. METHODS: Setting: institutional. PATIENTS: 232 patients and their caregivers. Four groups were created based on better eye characteristics: blind (best-corrected distance visual acuity [BCDVA] <3/60 or visual field <10 central degrees); severe VI (BCDVA ≤3/60 to <6/60; vertical cup-to-disc ratio ≥0.85 or neuroretinal rim width ≤0.1); moderate VI (BCDVA ≤6/60 to <6/18); or no or mild VI (controls: BCDVA ≥6/18) based on International Classification of Diseases-10 criteria and Foster and Quigley's consensus definition of glaucoma. PROCEDURE: telephone questionnaires. MAIN OUTCOME MEASURES: differences in perceptions and implications of COVID-19 infection across various levels of VI. Caregiver perceptions were a secondary outcome measure. RESULTS: Surveys were completed by 232 participants, with 58 participants in each VI group. Mean age was 58.9 ± 13.2 years old. Greater degrees of VI were associated with older age (P = .008) and lower education level (P = .046). Blind participants more commonly perceived vision as a risk factor for contracting COVID-19 (P = .045), were concerned about access to health care (P <.001), obtained news through word of mouth (P <.001), and less commonly wore masks (P = .003). Controls more commonly performed frequent handwashing (P = .001), were aware of telemedicine (P = .029), and had fewer concerns about social interactions (P = .020) than groups with substantial VI. All caregivers reported more frequent patient care since the COVID-19 pandemic began. CONCLUSIONS: The pandemic might have had a disproportionate impact on the visually impaired, and evidence-based assessments of COVID-19 health outcomes in this population are warranted.

Comparison of outcomes between Aurolab aqueous drainage implant placed in the superotemporal versus inferonasal quadrant.

AIM: To determine the outcomes of Aurolab aqueous drainage implant (AADI) placed in the superotemporal versus the inferonasal quadrant in adult eyes with refractory glaucoma. METHODS: This was a retrospective study of eyes that had AADI placement and completed a minimum of 2-year follow-up. The choice of the quadrant was at the surgeon's discretion and mainly depended on the amount of scarring and conjunctival mobility. The cumulative failure rate of the AADI was defined as intraocular pressure (IOP) >21 mm Hg or not reduced by 20% below baseline on two consecutive follow-up visits after 3 months, IOP ≤5 mm Hg on two consecutive follow-up visits after 3 months, reoperation for glaucoma or a complication, or loss of light perception vision. RESULTS: We included 84 eyes with AADI in the inferonasal quadrant versus 69 eyes in the superotemporal quadrant. A significant drop in IOP was seen in both groups (18.4±10.4 mm Hg in the inferonasal group vs 17.7±11.1 mm Hg in the superotemporal group; p=0.63) at 3-month follow-up and this was maintained until last follow-up. Best-corrected visual acuity, IOP, number of IOP-lowering medications and complications were similar between the two groups at all time points. The cumulative success rate at 2-year follow-up without IOP-lowering medications was 57.1% (47.1%-68.1%) in the inferonasal group and 50.7% (39.8%-63.1%) in the superotemporal group (p=0.47). CONCLUSIONS: Inferonasal AADI placement appears to be an equally safe and effective surgical option compared with superotemporal AADI placement and may be helpful in certain clinical situations.