A Health-Related Quality of Life Measure for Patients Who Undergo Minimally Invasive Glaucoma Surgery.

PURPOSE: To develop a standardized patient-reported outcome measure to assess the impact of glaucoma and treatment, including minimally invasive glaucoma surgery (MIGS), on health-related quality of life (HRQOL). DESIGN: Observational study before and after concomitant cataract and FDA-approved implantable MIGS device surgery to provide information on the measure's performance in assessing HRQOL. METHODS SETTING: Survey administration was done by electronic patient-reported outcomes (ePRO) application to patients at multiple sites on a computer, iPad, or similar device. PATIENT POPULATION: One hundred eighty-four adults completed a baseline survey, 124 completed a survey 3 months after surgery, and 106 completed the 1-month test-retest reliability survey. The age range was 37-89, and the average age was 72. Most of the respondents were female (57%), non-Hispanic White (81%), and had a college degree (56%). MAIN OUTCOME MEASURES: The Glaucoma Outcomes Survey (GOS) includes 42 questions assessing functional limitations (27 items), vision-related symptoms (7 items), psychosocial issues (7 items) and satisfaction with microinvasive glaucoma surgery (1 item). The three multiple-item scales were scored on a 0-100 range, with a higher score indicating worse health. RESULTS: Internal consistency reliability estimates ranged from 0.75 (vision-related symptoms) to 0.93 (functional limitations) and one-month test-retest intraclass correlations ranged from 0.65 (PROMIS global mental health) to 0.92 (functional limitations). Product-moment correlations among the GOS scales ranged from 0.56 to 0.60. Improvement in visual acuity in the study eye from baseline to the 3-month follow-up was significantly related to improvements in GOS functional limitations (r =0.18, p =0.0485), vision-related symptoms (r = 0.19, p = 0.0386), and psychosocial concerns (r = 0.18, p =0.0503). The highest proportion of responders to treatment was seen for the GOS functional limitations scale (48%), followed by GOS psychosocial issues (21%) and GOS vision-related symptoms (17%). CONCLUSIONS: This study provides initial support for using the GOS instrument in ophthalmic procedures such as MIGS. Further evaluation of the GOS in other samples, including different patient subgroups and clinical settings, will be valuable. The instrument may be useful for evaluations of other treatments for glaucoma.

Evaluation of Verteporfin as a Novel Antifibrotic Agent in a Rabbit Model of Glaucoma Filtration Surgery: A Pilot Study.

Purpose: Verteporfin is a benzoporphyrin derivative which is Food and Drug Administration-approved for treatment of choroidal neovascularization in conjunction with photodynamic therapy. It has been shown to prevent fibrosis and scar formation in several organs and represents a promising novel antifibrotic agent for glaucoma surgery. The goal of this study is to determine the effect of verteporfin on wound healing after glaucoma filtration surgery. Design: Preclinical study using a rabbit model of glaucoma filtration surgery. Subjects: Eight New Zealand white rabbits underwent glaucoma filtration surgery in both eyes. Methods: Eyes were randomized into 4 study groups to receive a postoperative subconjunctival injection of 1 mg/mL verteporfin (n = 4), 0.4 mg/mL mitomycin C (MMC; n = 4), 0.4 mg/mL MMC + 1 mg/mL verteporfin (n = 4), or balanced salt solution (BSS) control (n = 4). Bleb survival, vascularity, and morphology were graded using a standard scale over a 30-day period, and intraocular pressure (IOP) was monitored. At 30 days postoperative or surgical failure, histology was performed to evaluate for inflammation, local toxicity, and scarring. Main Outcome Measures: The primary outcome measure was bleb survival. Secondary outcome measures were IOP, bleb morphology, and bleb histology. Results: Compared to BSS control blebs, verteporfin-treated blebs demonstrated a trend toward increased surgical survival (mean 9.8 vs. 7.3 days, log rank P = 0.08). Mitomycin C-treated blebs survived significantly longer than verteporfin-treated blebs (log rank P = 0.009), with all but 1 MMC-treated bleb still surviving at postoperative day 30. There were no significant differences in survival between blebs treated with combination verteporfin + MMC and MMC alone. Mitomycin C-treated blebs were less vascular than verteporfin-treated blebs (mean vascularity score 0.3 ± 0.5 for MMC vs. 1.0 ± 0.0 for verteporfin, P < 0.01). Bleb histology did not reveal any significant toxicity in verteporfin-treated eyes. There were no significant differences in inflammation or scarring across groups. Conclusions: Although verteporfin remained inferior to MMC with regard to surgical survival, there was a trend toward increased survival compared with BSS control and it had an excellent safety profile. Further studies with variations in verteporfin dosage and/or application frequency are needed to assess whether this may be a useful adjunct to glaucoma surgery. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

The Association Between Frailty and Visual Field Loss in US Adults.

PURPOSE: To describe the association between visual field loss and frailty in a nationally representative cohort of US adults. DESIGN: Retrospective cross-sectional study. METHODS: The cohort included adults 40 years or older with complete eye examination data from the 2005-2006 and 2007-2008 National Health and Nutrition Examination Surveys (NHANES). Visual field loss (VFL) was determined by frequency doubling technology and a 2-2-1 algorithm. A 36-item deficit accumulation-based frailty index was used to divide subjects into 4 categories of increasing frailty severity. RESULTS: Of the 4897 participants, 4402 (93.2%) had no VFL, 301 (4.1%) had unilateral VFL, and 194 (2.73%) had bilateral VFL. Within the sample, 2 subjects197 (53.1%) were categorized as non-frail, 1659 (31.3%) as vulnerable, 732 (11.3%) as mildly frail, and 312 (4.3%) as most frail. In multivariable models adjusted for demographics, visual acuity, and history of cataract surgery, subjects with unilateral VFL had higher adjusted odds of being in a more frail category (adjusted odds ratio [aOR], 2.07; 95% CI, 1.42-3.02) than subjects without VFL. Subjects with bilateral VFL also had higher odds of a more frail category compared to subjects without VFL (aOR, 1.74; 95% CI, 1.20-2.52). CONCLUSIONS: In the 2005-2008 NHANES adult population, VFL is associated with higher odds of frailty, independent of central visual acuity loss. Frail individuals may be more susceptible to diseases that can cause VFL, and/or VFL may predispose to frailty. Additional studies are needed to determine the directionality of this relationship and to assess potential interventions.

Difficult decisions, filtration surgery, and the heartbreak of the numerator.

A 70-year-old man had progressive and severe glaucoma in each eye. He was intolerant to dorzolamide, brimonidine, and netarsudil. Each eye had prior selective laser trabeculoplasty (SLT) as well as phacoemulsification plus minimally invasive glaucoma surgery (MIGS) 6 years before current presentation (iStent [Glaukos Corp.] in the right eye and Cypass [Alcon Laboratories, Inc.] in the left eye). Postoperative acuities were 20/20 and 20/25 in the right and left eyes, respectively. When his left eye progressed with loss of central acuity despite peak intraocular pressures (IOPs) in the middle to upper teens, neuro-ophthalmology consultation was obtained (Figure 1JOURNAL/jcrs/04.03/02158034-202401000-00017/figure1/v/2023-12-22T124801Z/r/image-tiff). That workup included magnetic resonance imaging scan and hematologic screening, but all results were negative, and the neuro-ophthalmic consultant concluded that the vision loss was likely on the basis of glaucoma. Accordingly, a trabeculectomy was performed in the left eye achieving consistent IOPs in the range of 7 to 10 mm Hg without medications, rending the left eye stable since the filtration surgery nearly 2 years previously. The right eye continued to progress both subjectively and objectively, and on recent examination, the IOP measured 20 mm Hg and 09 mm Hg in the right and left eyes, respectively (Figure 2JOURNAL/jcrs/04.03/02158034-202401000-00017/figure2/v/2023-12-22T124801Z/r/image-tiff). Medications included timolol and latanoprostene bunod in the right eye only. Central corneal thickness was 526 µm and 527 µm in the right and left eyes, respectively. The visual acuity now measured 20/25 in the right eye and 20/250 in the left eye. The vertical cup-to-disc ratio was 0.9 in the right eye and 1.0 in the left eye. Gonioscopy revealed a wide open angle in each eye with a patent sclerostomy superiorly in the left eye. The conjunctiva and sclera were healthy and without scarring in the right eye. The bleb in the left eye was diffuse, lightly vascularized, and seidel negative. Axial length (AL) was 26.88 µm in the right eye and 26.77 µm in the left eye. The patient was in good health and was not anticoagulated. An extensive discussion ensued about the best course of action for the right eye. How would you proceed in managing definite progression in this individual's right eye, knowing that he had lost fixation in his left eye at similar pressures?

Glaucoma and Myopia: Diagnostic Challenges.

The rising global prevalence of myopia is a growing concern for clinicians, as it predisposes patients to severe ocular pathologies including glaucoma. High myopia can be associated with clinical features that resemble glaucomatous damage, which make an accurate glaucoma diagnosis challenging, particularly among patients with normal intraocular pressures. These patients may also present with established visual field defects which can mimic glaucoma, and standard imaging technology is less useful in disease detection and monitoring due to the lack of normative data for these anatomically unique eyes. Progression over time remains the most critical factor in facilitating the detection of early glaucomatous changes, and thus careful longitudinal follow-up of high-risk myopic patients is the most important aspect of management. Here, we review our current understanding of the complex relationship between myopia and glaucoma, and the diagnostic challenges and limitations of current testing protocols including visual field, intraocular pressure, and imaging. Furthermore, we discuss the clinical findings of two highly myopic patients with suspected glaucoma.

Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious).

INTRODUCTION: Laser trabeculoplasty is an effective and widely used treatment for glaucoma. A new laser technology, the Eagle direct selective laser trabeculoplasty (DSLT) device, may provide automated, fast, simple, safe and effective laser treatment for glaucoma in a broader range of clinical settings. This trial aims to test the hypothesis that translimbal DSLT is effective and not inferior to selective laser trabeculoplasty (SLT) in reducing intraocular pressure (IOP) in open angle glaucoma (OAG). METHODS AND ANALYSIS: This is a multicentre, randomised, controlled, investigator-masked study. The primary efficacy outcome is intergroup difference in mean change from baseline IOP measured at 6 months. Secondary outcomes include mean percentage reduction in IOP at 3, 6 and 12 months; proportion of participants with at least 20% reduction in IOP from baseline at 6 months; change in ocular hypotensive medications at 12 months and evaluation of safety. Participants were aged >= 40 years with OAG, including exfoliative or pigmentary glaucoma, or ocular hypertension with untreated or washed out IOP 22-35 mm Hg. TREATMENTS: DSLT: 120 shots, 3 ns, 400 µm spot size, energy 1.4-1.8 mJ delivered at the limbus over 2 s. SLT: approximately 100 shots, 3 ns, 400 µm spot size administered 360 degrees at the limbus using any gonioscopy lens, energy 0.3-2.6 mJ. A sample size of 164 is sufficient to detect a non-inferiority margin of 1.95 mm Hg for change from baseline IOP. CLINICAL TRIAL REGISTRATION NUMBER: NCT03750201, ISRCTN14033075.

Changes in glaucoma management following visual field testing and optical coherence tomography.

BACKGROUND: Optimal utilisation of investigations in glaucoma management remains unclear. We aimed to assess whether a temporal association exists between such testing and management changes. METHODS: Retrospective observational study using nationwide healthcare insurance claims database. Glaucoma outpatient encounters from patients aged ≥40 years with/without Humphrey visual field (HVF) and/or optical coherence tomography (OCT) were identified. An encounter was considered associated with an intervention if surgery occurred within 90 days, or if medication change or laser trabeculoplasty (LT) occurred within 30 days. RESULTS: 12 669 324 outpatient encounters of 1 863 748 individuals from 2003 to 2020 were included. HVF and OCT was performed during 32.8% and 22.2% of encounters respectively. Of the 36 763 (0.3%) encounters preceding surgery, 28.1% included HVF, 11.9% had OCT and 8.5% both. 79 181 (0.6%) visits preceded LT, of which 28.2% had HVF, 13.2% OCT and 9.3% both. Of the 515 899 (4.5%) encounters preceding medication changes, 29.1% had HVF, 16.7% OCT and 12.2% both. Compared with encounters with no investigations, those with HVF and/or OCT were associated with a 49% increased odds of a management change (p<0.001). In multivariate analyses, compared with encounters without investigations, visits with HVF alone had higher odds of subsequent surgery and LT, while HVF and/or OCT were associated with higher odds of medication change (p<0.001 for all). CONCLUSION: Glaucoma therapeutic changes occurred following approximately 5% of outpatient encounters. Surgery and LT were more likely to occur following a visit with a HVF rather than an OCT, while either investigation was associated with a higher odds of medication change.

Blood Pressure Measures and Incident Primary Open-Angle Glaucoma.

Purpose: To investigate the association of systemic blood pressure and incident primary open-angle glaucoma (POAG) using a large open-access database. Methods: Prospective cohort study included 484,268 participants from the UK Biobank without glaucoma at enrollment. Incident POAG events were recorded through assessment visits, hospital inpatient admissions, and primary care data. Blood pressure measures included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), and mean arterial pressure (MAP). Repeated measurements throughout the study period were analyzed as time-varying covariables. The parameters were modeled as both categorical and continuous nonlinear variables. The primary outcome measure was the relative hazard of incident POAG. Results: There were 2390 incident POAG events over 5,715,480 person-years of follow-up. Median follow-up was 12.08 years. In multivariable analyses, compared to SBP and PP in the normal range (SBP, 120-130 mmHg; PP, 40-50 mmHg), higher SBP and PP were associated with an increased risk of incident POAG (linear trend P = 0.038 for SBP, P < 0.001 for PP). Specifically, SBP of 130 to 140 mmHg or 140 to 150 mmHg was associated with a 1.16 higher hazard of incident POAG (95% CI, 1.01-1.32 and 1.01-1.33, respectively), whereas a PP of greater than 70 mmHg was associated with a 1.13 higher hazard of incident glaucoma (95% CI, 1.00-1.29). In multivariable models, no statistically significant associations were found for DBP or MAP with incident glaucoma. These findings were similar when blood pressure measures were modeled as continuous variables. Conclusions: Higher SBP and PP were associated with an increased risk of incident POAG. Further studies are required to characterize these relationships better.

Real-World Outcomes of Glaucoma Filtration Surgery Using Electronic Health Records: An Informatics Study.

PRCIS: Utilizing an automated pipeline for data extraction from electronic health records provides real-world information on the success of various glaucoma procedures, with tube shunt implantation associated with increased failure rates compared with trabeculectomy. BACKGROUND: We aimed to evaluate the long-term survival of glaucoma surgeries using an automated pipeline for extraction of outcomes from electronic health records. METHODS: A retrospective observational study from a single academic center. Patients undergoing trabeculectomy, Ex-PRESS shunt, Baerveldt, and Ahmed tube shunt insertion from 2009 to 2018 were identified from electronic health record procedure codes. Patient characteristics were identified from structured and unstructured fields using a previously validated natural language processing pipeline. RESULTS: Five hundred twelve patients underwent 711 glaucoma surgeries: 287 trabeculectomies, 47 Ex-PRESS shunts, 274 Baerveldt and 103 Ahmed tube implantations. The Median follow-up was 359 days. The mean baseline IOP was 24.4 mm Hg (SD 10.9), and 73.1% were on ≥3 medications. Compared with trabeculectomy, tube shunt surgery had a higher risk of failure (Baerveldt: Hazard Ratio (HR) 1.44, 95% CI 1.02 to 2.02; Ahmed: HR 2.01, 95% CI 1.28 to 3.17). Previous glaucoma surgery was associated with increased failure (≥2 previous surgeries: HR 2.74, 95% CI 1.62 to 4.64), as were fewer baseline medications (<3 medications: HR 2.96, 95% CI 2.12 to 4.13) and male sex (HR 1.40, 95% CI 1.03 to 1.90). At 1 year, tube shunt patients had a 2.53 mm Hg ( P =0.002) higher IOP compared with trabeculectomy patients. CONCLUSIONS: Baerveldt and Ahmed tube shunt implantation was associated with increased failure compared with trabeculectomy. Fewer baseline medications, previous glaucoma surgeries, and male sex were also risk factors for failure. These results demonstrate the utility of applying an informatics pipeline to electronic health records to investigate key clinical questions using real-world evidence.

Energy Dose-Response in Selective Laser Trabeculoplasty: A Review.

PRCIS: A literature review of selective laser trabeculoplasty (SLT) energy dose-response found no definitive relationship between intraocular pressure (IOP) reduction with respect to total or pulse energy, race, pigmentation, or application pattern. PURPOSE: SLT is a safe and effective treatment for lowering IOP. Although evidence is mounting for the advantage of its use as a first-line treatment for IOP reduction, the SLT procedures in use vary widely. The purpose of this literature review was to investigate whether there were any relationships between SLT energy and efficacy for lowering IOP in the published literature. METHODS: A literature review was undertaken that included studies in which energy levels required for successful SLT treatment were investigated: in general, with respect to angle pigmentation, race or ethnicity, and treatment arc extent. RESULTS: There was no indication that higher (or lower) energy used in the treatment leads to greater (or less) IOP reduction. Similar results were obtained regarding the level of trabecular meshwork pigmentation. Race was not found to be associated with altered dose response in SLT. There were indications that treating the full 360 degrees, as opposed to smaller arcs, could be beneficial for more IOP reduction. IOP reduction from SLT was found to be similar to that provided by topical medications. CONCLUSIONS: The optimal energy level of SLT needed for IOP reduction has not yet been definitively established, with all reported pulse energies resulting in similar IOP reduction. Furthermore, similar lack of conclusive findings exists regarding optimal SLT energy dosage for use in different races and degrees of trabecular meshwork pigmentation. This parameter and each of the abovementioned factors requires further research.

Outcomes of Primary Trabeculectomy versus Combined Phacoemulsification-Trabeculectomy Using Automated Electronic Health Record Data Extraction.

PURPOSE: Cataract is a known effect of trabeculectomy (TE), but some surgeons are hesitant to perform combined phacoemulsification-TE (PTE) due to a risk of increased TE failure. Herein, we compare intraocular pressure (IOP) lowering between trabeculectomy (TE) and phacoemulsification-TE (PTE) and investigate factors that impact patient outcomes. METHODS: We performed a retrospective study of adults undergoing primary TE or PTE at our institution from 2010 to 2017. We used Kaplan-Meier survival analysis to investigate time to TE failure, and Cox proportional hazards modeling to investigate predictors of TE failure, defined as undergoing a second glaucoma surgery or using more IOP-lowering medications than pre-operatively. RESULTS: 318 surgeries (218 TE; 100 PTE) from 268 patients were included. Median follow-up time was 753 days. Mean baseline IOP was 21.1 mmHg. There were no significant differences in IOP between TE and PTE groups beyond postoperative year 1, with 28.9-46.5% of TE and 35.5-44.4% of PTE groups achieving IOP ≤10. Final IOP was similar in both groups (p = 0.22): 12.41 (SD 4.18) mmHg in the TE group and 14.05 (SD 5.45) in the PTE group. 84 (26.4%) surgeries met failure criteria. After adjusting for surgery type, sex, age, race, surgeon, and glaucoma diagnosis there were no significant differences in TE failure. CONCLUSION: This study suggests there is no significant difference in the risk of TE failure in patients receiving TE versus those receiving PTE.

Long-term Outcomes from the HORIZON Randomized Trial for a Schlemm's Canal Microstent in Combination Cataract and Glaucoma Surgery.

PURPOSE: To present the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone. DESIGN: Prospective, multicenter, controlled randomized clinical trial. PARTICIPANTS: Patients with cataract and primary open-angle glaucoma treated with 1 or more glaucoma medications, washed-out diurnal intraocular pressure (DIOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: Eyes were randomized 2:1 to receive a Hydrus Microstent (HMS; Ivantis, Inc) or no stent after successful CS. MAIN OUTCOME MEASURES: Intraocular pressure (IOP), glaucoma medication use, repeat glaucoma surgery, visual acuity, visual field, procedure-related adverse events, and corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only. Study groups were well matched for preoperative IOP, medication use, washed-out DIOP, and glaucoma severity. Five-year follow-up was completed in 80% of patients. At 5 years, the HMS group included a higher proportion of eyes with IOP of 18 mmHg or less without medications than the CS group (49.5% vs. 33.8%; P = 0.003), as well as a greater likelihood of IOP reduction of 20% or more without medications than the CS group (54.2% vs. 32.8%; P < 0.001). The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001). The cumulative risk of incisional glaucoma surgery was lower in the HMS group (2.4% vs. 6.2%; P = 0.027, log-rank test). No clinical or statistically significant differences were found in the rate of endothelial cell loss from 3 to 60 months between the HMS and CS alone groups (P = 0.261). CONCLUSIONS: The addition of a Schlemm's canal microstent in conjunction with CS was safe, resulted in lowered IOP and medication use, and reduced the need for postoperative incisional glaucoma filtration surgery compared with CS after 5 years. Long-term presence of the implant did not affect the corneal endothelium adversely.

The Association among Blood Pressure, Blood Pressure Medications, and Glaucoma in a Nationwide Electronic Health Records Database.

PURPOSE: To measure the association among blood pressure (BP), BP medications, and glaucoma using the All of Us Research Program database. DESIGN: A retrospective, longitudinal cohort study leveraging a national electronic health record (EHR) database administered by the National Institutes of Health. PARTICIPANTS: Eye patients in the All of Us Research Program database with at least 15 months of follow-up and 1 BP measurement. METHODS: Univariable and multivariable Cox regression models predicted the risk of developing incident open-angle glaucoma (OAG). Mean arterial pressure (MAP) and the number of BP medication classes were entered as time-varying predictors to account for changes over time. MAIN OUTCOME MEASURES: The risk of developing incident OAG, as defined by billing diagnosis codes. RESULTS: Of 20 815 eligible eye patients who qualified for this study, 462 developed OAG. Low BP (MAP < 83.0 mmHg) was associated with increased risk of developing OAG (hazard ratio [HR], 1.32; 95% confidence interval [CI], 1.04-1.67). High BP (MAP > 101.3 mmHg) and the number of BP medication classes were not associated with OAG after adjustment for covariates. Other risk factors associated with OAG included being Black (HR, 3.31, 95% CI, 2.63-4.17), Hispanic or Latino (HR, 2.53, 95% CI, 1.94-3.28), Asian (HR, 2.22, 95% CI, 1.24-3.97), older in age (80+ years, HR, 20.1, 95% CI, 9.10-44.5), and diabetic (HR, 1.32, 95% CI, 1.04-1.67). Female gender was associated with decreased hazard of developing OAG (HR, 0.66, 95% CI, 0.55-0.80). No significant interaction was observed between MAP and the number of BP medications on the risk of developing OAG. CONCLUSIONS: We found that low BP is associated with increased risk of developing OAG in a national longitudinal EHR database. We did not find evidence supporting a differential effect of medically treated and untreated low BP. This study adds to the body of literature implicating vascular dysregulation as a potential etiology for the development of OAG, particularly emphasizing the lack of influence of BP medications on this relationship.

Factors impacting cumulative dissipated energy levels and postoperative visual acuity outcome in cataract surgery.

PURPOSE: To determine factors impacting cumulative dissipated energy (CDE) and postoperative best-corrected visual acuity (BCVA) in phacoemulsification. DESIGN: Review of 1102 cases at University of California, San Francisco (UCSF) and at Zhongshan Ophthalmic Center (ZOC), China. SUBJECTS: Patients who underwent cataract surgery at UCSF 03/2014-03/2019 and at ZOC 10/2018-05/2019. METHODS: Patient demographics, medical history, routine ocular examination, and surgical information, including disassembly method, complications, and surgeon training level were recorded. Univariable and multivariable regression models were used to determine factors associated with CDE and good postoperative BCVA (20/40 or better) at 1 month. OUTCOME MEASURES: CDE, postoperative BCVA. RESULTS: In multivariable analysis, patient age at time of surgery, diabetes, degree of nuclear sclerosis (NS), white-to-white corneal diameter, disassembly method, preoperative BCVA, surgeon training level, and surgical center were significantly associated with CDE. Log10CDE increased by 0.20-0.31 for patient age ≥ 70 years, by 0.07 if the patient had diabetes, by 0.12-0.41 for NS grade ≥ 2, by 0.48 per 10 mm increase in white-to-white corneal diameter, by 0.34-0.47 for disassembly method other than non-stop chop, by 0.16 per unit increase in preoperative logMAR BCVA, and by > 0.09 when phacoemulsification was performed by residents early in their training. Log10CDE was 0.33 higher at UCSF than ZOC. In multivariable analysis, worse baseline visual acuity and age above 90 years at time of surgery decreased the odds of good BCVA (OR = 0.26 per unit increase in preoperative logMAR BCVA; OR = 0.12 for age > 90); comorbid retinal issues decreased the odds of good postoperative BCVA (OR = 0.13-0.39); greater anterior chamber depth (ACD) or shorter axial length (AL), increased the odds of good postoperative outcome (OR = 2.64 per 1 mm increase ACD, OR = 0.84 per 1 mm increase AL). CONCLUSIONS: Cataract grade determined by slit lamp exam and, for the first time, older patient age, were noted to be important predictors of high CDE. CDE was not a risk factor for postoperative BCVA measured at postoperative 1 month. When surgery was performed by trainees under supervision, lower training level was associated with higher CDE, but not with worse postoperative BCVA.

Vision-Targeted Health-Related Quality-of-Life Survey for Evaluating Minimally Invasive Glaucoma Surgery.

PURPOSE: To develop a vision-targeted health-related quality-of-life instrument for patients with glaucoma who are candidates for minimally invasive glaucoma surgery (MIGS). DESIGN: Development of a health-related quality-of-life instrument. PARTICIPANTS: Twelve practicing ophthalmologists and 41 glaucoma patients. METHODS: A questionnaire was constructed to assess functional limitations, vision-related symptoms, aesthetics, psychosocial issues, and surgical satisfaction for MIGS candidates. Questions were drafted after a review of the literature and subsequently refined based upon input from 1 physician and 4 patient focus groups. Nineteen cognitive interviews were used to ensure that questions were understandable to respondents. RESULTS: The focus group identified the following key issues and concerns as being important to glaucoma patients: functional limitations (eg, driving), bodily discomfort (eg, stinging from drops), changes in appearance (eg, drooping eyelid), and psychosocial concerns (eg, mental burden associated with a diagnosis of glaucoma, financial burden of treatment). Cognitive interviews resulted in the following improvements to the questionnaire: changes in wording to clarify lighting conditions, and additional questions addressing psychosocial issues, such as job loss, severity of disease, and perception of MIGS. CONCLUSIONS: A patient-reported outcomes instrument, the Glaucoma Outcomes Survey, was developed to evaluate MIGS for patients with mild to moderate glaucoma. Next steps include electronic administration to patients selected from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) registry. An electronic patient-reported outcomes platform will be used to administer the questionnaire before and after MIGS. The questionnaire will improve understanding of how surgical interventions such as MIGS impact vision-targeted health-related quality-of-life in glaucoma patients.

Three-Year Findings of the HORIZON Trial: A Schlemm Canal Microstent for Pressure Reduction in Primary Open-Angle Glaucoma and Cataract.

PURPOSE: To report 3-year outcomes of the HORIZON study comparing cataract surgery (CS) with Hydrus Microstent (Ivantis, Inc) implantation versus CS alone. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Five hundred fifty-six eyes from 556 patients with cataract and primary open-angle glaucoma (POAG) treated with 1 or more glaucoma medication, washed out diurnal intraocular pressure (IOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: After phacoemulsification, eyes were randomized 2:1 to receive a Hydrus Microstent or no stent. Follow-up included comprehensive eye examinations through 3 years. MAIN OUTCOME MEASURES: Outcome measures included IOP, medical therapy, reoperation rates, visual acuity, adverse events, and changes in corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to microstent treatment and 187 to CS only. Preoperative IOP, medication use, washed-out diurnal IOP, and glaucoma severity did not differ between the two treatment groups. At 3 years, IOP was 16.7 ± 3.1 mmHg in the microstent group and 17.0 ± 3.4 mmHg in the CS group (P = 0.85). The number of glaucoma medications was 0.4 ± 0.8 in the microstent group and 0.8 ± 1.0 in the CS group (P < 0.001), and 73% of microstent group eyes were medication free compared with 48% in the CS group (P < 0.001). The microstent group included a higher proportion of eyes with IOP of 18 mmHg or less without medications compared with the CS group (56.2% vs. 34.6%; P < 0.001), as well as IOP reduction of at least 20%, 30%, or 40% compared with CS alone. The cumulative probability of incisional glaucoma surgery was lower in the microstent group (0.6% vs. 3.9%; hazard ratio, 0.156; 95% confidence interval, 0.031-0.773; P = 0.020). No difference was found in postoperative corneal endothelial cell loss between groups. No procedure- or device-related serious adverse events resulting in vision loss occurred in either group. CONCLUSIONS: Combined CS and microstent placement for mild to moderate POAG is safe, more effective in lowering IOP with fewer medications, and less likely to result in further incisional glaucoma filtration surgery than CS alone at 3 years.