Association of Contrast Sensitivity With Eye Disease and Vision-Related Quality of Life.

PURPOSE: To investigate contrast sensitivity (CS) as a screening tool to detect eye disease and assess its association with both eye disease and vision-related quality of life. DESIGN: Cross-sectional study. METHODS: Setting and population: Adults receiving care from a free clinic and a Federally Qualified Health Center in Michigan. MAIN OUTCOME MEASURES: Screening positive for eye disease and Visual Function Questionnaire (VFQ) score. OBSERVATION: Participants received a vision exam reviewed via telemedicine for disease, completed a demographic survey, and the 9-item VFQ. The ability of CS to predict eye disease was explored and area under the curve (AUC) is reported. Logistic and linear regression were used to investigate the continuous effect of CS on the probability of screening positive for eye disease and VFQ score, respectively, adjusting for age and visual acuity. RESULTS: 1159 included participants were, on average, 54.9 ± 14.5 years old, 62% identified as female, 34% as White, 54% as Black, 10% as Hispanic/Latino, and reported mean VFQ score of 79.7 ± 15.3. CS ranged from 0.00 to 1.95 log units (mean = 1.54 ± 0.24), 21% of eyes had glaucoma, 19% cataract, 6% DR, and 2% AMD. AUCs were 0.53 to 0.73. A 0.3 log unit decrease in better eye CS was associated with increased odds of glaucoma (odds ratio [OR] = 1.35, confidence interval [CI] = 1.09-1.67), cataract (OR = 1.35, CI = 1.05-1.72), DR (OR = 2.05, CI = 1.51-2.77), and AMD (OR = 2.08, CI = 1.10-3.91). A 0.3 log unit increase in better eye CS was associated with a 5.9 unit increase in VFQ. CONCLUSION: While CS alone is not sufficient to identify people with eye disease, it is an important measure of visual function that can add value to comprehensive eye screening.

Visual Impairment from Uncorrected Refractive Error among Participants in a Novel Program to Improve Eye Care Access among Low-Income Adults in Michigan.

PURPOSE: To assess the rate of visual impairment (VI) from uncorrected refractive error (URE) and associations with demographic and socioeconomic factors among low-income patients presenting to the Michigan Screening and Intervention for Glaucoma and Eye Health through Telemedicine (MI-SIGHT) program. DESIGN: Cross-sectional study. PARTICIPANTS: Adults ≥ 18 years without acute ocular symptoms. METHODS: MI-SIGHT program participants received a telemedicine-based eye disease screening and ordered glasses through an online optical store. Participants were categorized based on refractive error (RE) status: VI from URE (presenting visual acuity [PVA], ≤ 20/50; best-corrected visual acuity [BCVA], ≥ 20/40), URE without VI (PVA, ≥ 20/40; ≥ 2-line improvement to BCVA), and no or adequately corrected RE (PVA, ≥ 20/40; < 2-line improvement to BCVA). Patient demographics, self-reported visual function, and satisfaction with glasses obtained through the program were compared among groups using analysis of variance, Kruskal-Wallis, chi-square, and Fisher exact testing. MAIN OUTCOME MEASURES: PVA, BCVA, and presence of VI (defined as PVA ≤ 20/50). RESULTS: Of 1171 participants enrolled in the MI-SIGHT program during the first year, average age was 55.1 years (SD = 14.5), 37.7% were male, 54.1% identified as Black, and 1166 (99.6%) had both PVA and BCVA measured. VI was observed in 120 participants (10.3%); 96 had VI from URE (8.2%), 168 participants (14.4%) had URE without VI, and 878 (75.3%) had no or adequately corrected RE. A smaller percentage of participants with VI resulting from URE reported having a college degree, and a larger percentage reported income < $10 000 compared with participants with no or adequately corrected RE (3.2% vs. 14.2% [P = 0.02]; 45.5% vs. 21.6% [P < 0.0001], respectively). Visual function was lowest among participants with VI from URE, followed by those with URE without VI, and then those with no or adequately corrected RE (9-item National Eye Institute Visual Function Questionnaire composite score, 67.3 ± 19.6 vs. 77.0 ± 14.4 vs. 82.2 ± 13.3, respectively; P < 0.0001). In total, 71.2% (n = 830) ordered glasses for an average cost of $36.80 ± $32.60; 97.7% were satisfied with their glasses. CONCLUSIONS: URE was the main cause of VI at 2 clinics serving low-income communities and was associated with reduced vision-related quality of life. An online optical store with lower prices made eyeglasses accessible to low-income patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Relationship between Unstable Housing, Food Insecurity, and Vision Status in the MI-SIGHT Community Eye Disease Screening Program.

PURPOSE: Assess rate of visual impairment (VI) from uncorrected refractive error (URE) and associations with demographic and socioeconomic factors among low-income patients presenting to the Michigan Screening and Intervention for Glaucoma and Eye Health through Telemedicine (MI-SIGHT) program. DESIGN: Cross-sectional study. PARTICIPANTS: Adults ≥ 18 years without acute ocular symptoms. METHODS: MI-SIGHT program participants received a telemedicine-based eye disease screening and ordered glasses through an online optical shop. Participants were categorized based on refractive error (RE) status: VI from URE (presenting visual acuity [PVA] ≤ 20/50, best corrected visual acuity [BCVA] ≥ 20/40), URE without VI (PVA ≥ 20/40, had ≥ 2 lines of improvement to BCVA), and no or adequately corrected RE (PVA ≥ 20/40, < 2 line improvement to BCVA). Patient demographics, self-reported visual function, and satisfaction with glasses obtained through the program were compared between groups using analysis of variance, Kruskal-Wallis, chi-square, and Fisher exact testing. MAIN OUTCOME MEASURES: PVA, BCVA, and presence of VI (defined as PVA ≤ 20/50). RESULTS: Of 1171 participants enrolled in the MI-SIGHT program during the first year, the average age was 55.1 years (standard deviation = 14.5), 37.7% were male, 54.1% identified as Black, and 1166 (99.6%) had both PVA and BCVA measured. VI was observed in 120 (10.3%); 96 had VI from URE (8.2%), 168 (14.4%) had URE without VI, and 878 (75.3%) had no or adequately corrected RE. A smaller percentage of participants with VI from URE reported having a college degree and a larger percentage reported income < $10 000 compared to participants with no or adequately corrected RE (3.2% versus 14.2%, P = 0.02; 45.5% versus 21.6%, respectively, P < 0.0001. Visual function was lowest among participants with VI from URE, followed by those with URE without VI, and then those with no or adequately corrected RE (VFQ9 composite score 67.3 ± 19.6 versus 77.0 ± 14.4 versus 82.2 ± 13.3, respectively; P < 0.0001). 71.2% (n = 830) ordered glasses for an average cost of $36.80 ± $32.60; 97.7% were satisfied with their glasses. CONCLUSIONS: URE was the main cause of VI at 2 clinics serving low-income communities and was associated with reduced vision-related quality of life. An online optical shop with lower prices made eyeglasses accessible to low-income patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

New Devices in Glaucoma.

Glaucoma remains a leading cause of blindness globally. Minimally invasive treatment techniques are rapidly expanding the availability of therapeutic options for glaucoma. These include devices aimed at enhancing outflow through the subconjunctival space, Schlemm's canal, and suprachoroidal space, sustained-release drug delivery devices, and extraocular devices aiming to reduce glaucomatous progression through other novel means. In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma. Further studies are required to determine the long-term efficacy of these devices and how they will integrate into the current landscape of glaucoma management.

Social Deprivation and the Risk of Screening Positive for Glaucoma in the MI-SIGHT Telemedicine-Based Glaucoma Detection Program.

PURPOSE: To assess whether increased poverty is associated with increased risk of screening positive for glaucoma or suspected glaucoma in a large public screening and intervention program. DESIGN: Cross-sectional study from 2020 to 2022. PARTICIPANTS: Adults ≥ 18 years old without acute ocular symptoms. METHODS: Michigan Screening and Intervention for Glaucoma and eye Health through Telemedicine (MI-SIGHT) program participants' sociodemographic characteristics and area deprivation index (ADI) values were summarized from the clinical sites, which included a free clinic and a Federally Qualified Health Center (FQHC). The ADI, a composite measure of neighborhood deprivation (range, 1-10; 10 is worst deprivation), was assigned on the basis of the participants' addresses. Group comparisons were performed via 2-sample t tests or Wilcoxon Mann-Whitney tests for continuous measures and chi-square tests or Fisher exact tests with Monte Carlo simulation for categorical measures; Holm adjustment was used for multiple comparisons. MAIN OUTCOME MEASURES: Risk factors for screening positive for glaucoma or suspected glaucoma. RESULTS: Of the 1171 enrolled participants, 1165 (99.5%) completed the screening: 34% at the free clinic and 66% at the FQHC. Participants were on average aged 55.1 ± 14.5 years, 62% were women, 54% self-reported as Black/African-American, 34% White, 10% Hispanic or Latino, and 70% earned < $30 000 annually. The mean ADI was 7.2 ± 3.1. The FQHC had higher (worse) ADI than the free clinic (free clinic: 4.5 ± 2.9, FQHC: 8.5 ± 2.1, P < 0.0001). One-quarter (24%) of participants screened positive for glaucoma or suspected glaucoma. Screening positive for glaucoma or suspected glaucoma was associated with being older (P = 0.01), identifying as Black/African-American (P = 0.0001), having an established eyecare clinician (P = 0.0005), and not driving a personal vehicle to the appointment (P = 0.001), which is a proxy for increased poverty. Participants who screened positive had worse ADI than those who screened negative (7.7 ± 2.8 vs. 7.0 ± 3.2, P = 0.002). A larger percentage of White participants screened positive at the FQHC compared with White participants at the free clinic (21.3% vs. 12.3%, P = 0.01). FQHC White participants had worse ADI than free clinic White participants (7.5 ± 2.5 vs. 3.7 ± 2.7, P < 0.0001). CONCLUSIONS: Personal poverty, assessed as not driving a personal vehicle to the appointment, and neighborhood-level poverty were both associated with increased rates of screening positive for glaucoma or suspected glaucoma. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Device-modified trabeculectomy for glaucoma.

BACKGROUND: Glaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for glaucoma aims to reduce intraocular pressure (IOP) to slow or prevent further vision loss. IOP can be lowered with medications, laser, or incisional surgery. Trabeculectomy is a surgical approach which lowers IOP by shunting aqueous humor to a subconjunctival bleb. Device-modified trabeculectomy techniques are intended to improve the durability and safety of this bleb-forming surgery. Trabeculectomy-modifying devices include the Ex-PRESS, the XEN Gel Stent, the PreserFlo MicroShunt, as well as antifibrotic materials such as Ologen, amniotic membrane, expanded polytetrafluoroethylene (ePTFE) membrane, Gelfilm and others. However, the comparative effectiveness and safety of these devices are uncertain. OBJECTIVES: To evaluate the benefits and harms of different devices as adjuncts to trabeculectomy on IOP control in eyes with glaucoma compared to standard trabeculectomy. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was August 2021. SELECTION CRITERIA: We included randomized controlled trials in participants with glaucoma comparing device-modified trabeculectomy techniques with standard trabeculectomy. We included studies that used antimetabolites in either or both treatment groups. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. change in IOP and 2. mean postoperative IOP at one year. Our secondary outcomes were 3. mean change in IOP from baseline, 4. mean postoperative IOP at any time point, 5. mean best-corrected visual acuity (BCVA), 6. visual field change, 7. quality of life, 8. proportion of participants who are drop-free at one year, 9. mean number of IOP lowering medications at one year, and 10. proportion of participants with complications. MAIN RESULTS: Eight studies met our inclusion criteria, of which seven were full-length journal articles and one was a conference abstract. The eight studies included 961 participants with glaucoma, and compared two types of devices implanted during trabeculectomy versus standard trabeculectomy. Seven studies (462 eyes, 434 participants) used the Ex-PRESS, and one study (527 eyes, 527 participants) used the PreserFlo MicroShunt. No studies using the XEN Gel Stent implantation met our criteria. The studies were conducted in North America, Europe, and Africa. Planned follow-up periods ranged from six months to five years. The studies were reported poorly, which limited our ability to judge risk of bias for many domains. None of the studies explicitly masked outcome assessment. We rated seven studies at high risk of detection bias. Low-certainty of evidence from five studies showed that using the Ex-PRESS plus trabeculectomy compared with standard trabeculectomy may be associated with a slightly lower IOP at one year (mean difference (MD) -1.76 mmHg, 95% confidence interval (CI) -2.81 to -0.70; 213 eyes). Moderate-certainty of evidence from one study showed that using the PreserFlo MicroShunt may be associated with a slightly higher IOP than standard trabeculectomy at one year (MD 3.20 mmHg, 95% CI 2.29 to 4.11). Participants who received standard trabeculectomy may have a higher risk of hypotony compared with those who received device-modified trabeculectomy, but the evidence is uncertain (RR 0.73, 95% CI 0.46 to 1.17; I² = 38%; P = 0.14). In the subgroup of participants who received the PreserFlo MicroShunt, there was a lower risk of developing hypotony or shallow anterior chamber compared with those receiving standard trabeculectomy (RR 0.44, 95% CI 0.25 to 0.79; 526 eyes). Device-modified trabeculectomy may lead to less subsequent cataract surgery within one year (RR 0.46, 95% CI 0.27 to 0.80; I² = 0%). AUTHORS' CONCLUSIONS: Use of an Ex-PRESS plus trabeculectomy may produce greater IOP reduction at one-year follow-up than standard trabeculectomy; however, due to potential biases and imprecision in effect estimates, the certainty of evidence is low. PreserFlo MicroShunt may be inferior to standard trabeculectomy in lowering IOP. However, PreserFlo MicroShunt may prevent postoperative hypotony and bleb leakage. Overall, device-modified trabeculectomy appears associated with a lower risk of cataract surgery within five years compared with standard trabeculectomy. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine Program: First-Year Outcomes and Implementation Costs.

PURPOSE: The Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (MI-SIGHT) program aims to engage people who are at high risk of glaucoma; we assess first-year outcomes and costs. DESIGN: Clinical cohort study. METHODS: Participants ≥18 years of age were recruited from a free clinic and a federally qualified health center in Michigan. Ophthalmic technicians in the clinics collected demographic information, visual function, ocular health history, measured visual acuity, refraction, intraocular pressure, pachymetry, pupils, and took mydriatic fundus photographs and retinal nerve fiber layer optical coherence tomography. Data were interpreted by remote ophthalmologists. During a follow-up visit, technicians shared ophthalmologist recommendations, dispensed low-cost glasses, and collected participant satisfaction. The primary outcome measures were prevalence of eye disease, visual function, program satisfaction, and costs. Observed prevalence was compared with national disease prevalence rates using z tests of proportions. RESULTS: Among 1171 participants, the average age was 55 years (SD 14.5 years), 38% were male, 54% identified as Black, 34% as White, 10% as Hispanic, 33% had less than or equal to a high school education, and 70% had an annual income <$30,000. The prevalence of visual impairment was 10.3% (national average 2.2%), glaucoma and suspected glaucoma 24% (national average 9%), macular degeneration 2.0% (national average 1.5%), and diabetic retinopathy 7.3% (national average 3.4%) (P < .0001). Seventy-one percent of participants received low-cost glasses, 41% were referred for ophthalmology follow-up, and 99% were satisfied or very satisfied with the program. Startup costs were $103,185; recurrent costs were $248,103 per clinic. CONCLUSIONS: Telemedicine eye disease detection programs in low-income community clinics effectively identify high rates of pathology.

Engagement in the Michigan Screening and Intervention for Glaucoma and Eye Health through Telemedicine Program: Comparing the Effect of Clinic versus Community-Based Recruitment Strategies.

PURPOSE: To determine the effectiveness of adding community-based recruitment to clinic-based recruitment to engage participants in a glaucoma detection program. DESIGN: Prospective cohort study. SUBJECTS: Anyone ≥ 18 years of age who does not meet exclusion criteria. METHODS: The Michigan Screening and Intervention for Glaucoma and Eye Health through Telemedicine (MI-SIGHT) program tests a novel way of improving glaucoma detection in communities with populations at high risk for disease, including people who identify as Black and Hispanic and those living with low socioeconomic status. The MI-SIGHT program is conducted in a free clinic (Ypsilanti, MI) and in a federally qualified health center (FQHC) (Flint, MI). Community engagement methods were used to identify outreach strategies to enhance recruitment. Participants were asked "How did you hear about the MI-SIGHT program?" and responses were summarized overall and by clinic and compared between clinic-based and community-based recruitment strategies. MAIN OUTCOME MEASURES: Proportion recruited by location, within or outside of the clinic. RESULTS: In total, 647 participants were recruited in the first 11 months of the study, 356 (55.0%) at the free clinic over 11 months and 291 (45.0%) at the FQHC over 6 months. Participants were on average 54.4 years old (standard deviation = 14.2); 60.9% identified as female, 45.6% identified as Black, 37.8% identified as White, 9.6% identified as Hispanic, and 10.9% had less than high school education. Participants reported hearing about the MI-SIGHT program from a clinic phone call (n = 168, 26.1%), a friend (n = 112, 17.4%), nonmedical clinic staff (n = 100, 15.5%), a clinic doctor (n = 77, 11.9%), an in-clinic brochure or flyer (n = 51, 7.9%), a community flyer (n = 44, 6.8%), the clinic website or social media (n = 28, 4.3%), or an "other" source (n = 65, 10.1%). Recruiting from the community outside the medical clinics increased participation by 265% at the free clinic and 46% at the FQHC. CONCLUSIONS: The Community Advisory Board recommendation to use community-based recruitment strategies in addition to clinic-based strategies for recruitment resulted in increased program participation. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

3D imaging of aqueous veins and surrounding sclera using a dual-wavelength photoacoustic microscopy.

Understanding aqueous outflow resistance at the level of aqueous veins has been a challenge to the management of glaucoma. This study investigated resolving the anatomies of aqueous veins and the textures of surrounding sclera using photoacoustic microscopy (PAM). A dual wavelength PAM system was established and validated using imaging phantoms, porcine and human globes perfused with an optical contrast agent ex vivo. The system shows lateral resolution of 8.23 µm and 4.70 µm at 1200 nm and 532 nm, respectively, and an axial resolution of 27.6 µm. The system is able to separately distinguish the aqueous veins and the sclera with high contrast in full circumference of the porcine and human globes.

Minimally Invasive Glaucoma Surgical Techniques for Open-Angle Glaucoma: An Overview of Cochrane Systematic Reviews and Network Meta-analysis.

IMPORTANCE: Glaucoma affects more than 75 million people worldwide. Intraocular pressure (IOP)-lowering surgery is an important treatment for this disease. Interest in reducing surgical morbidity has led to the introduction of minimally invasive glaucoma surgeries (MIGS). Understanding the comparative effectiveness and safety of MIGS is necessary for clinicians and patients. OBJECTIVE: To summarize data from randomized clinical trials of MIGS for open-angle glaucoma, which were evaluated in a suite of Cochrane reviews. DATA SOURCES: The Cochrane Database of Systematic Reviews including studies published before June 1, 2021. STUDY SELECTION: Reviews of randomized clinical trials comparing MIGS with cataract extraction alone, other MIGS, traditional glaucoma surgery, laser trabeculoplasty, or medical therapy. DATA EXTRACTION AND SYNTHESIS: Data were extracted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines by one investigator and confirmed by a second. Methodologic rigor was assessed using the AMSTAR 2 appraisal tool and random-effects network meta-analyses were conducted. MAIN OUTCOMES AND MEASURES: The proportion of participants who did not need to use medication to reduce intraocular pressure (IOP) postsurgery (drop-free). Outcomes were analyzed at short-term (<6 months), medium-term (6-18 months), and long-term (>18 months) follow-up. RESULTS: Six eligible Cochrane reviews were identified discussing trabecular bypass with iStent or Hydrus microstents, ab interno trabeculotomy with Trabectome, subconjunctival and supraciliary drainage devices, and endoscopic cyclophotocoagulation. Moderate certainty evidence indicated that adding a Hydrus safely improved the likelihood of drop-free glaucoma control at medium-term (relative risk [RR], 1.6; 95% CI, 1.4 to 1.8) and long-term (RR, 1.6; 95% CI, 1.4 to 1.9) follow-up and conferred 2.0-mm Hg (95% CI, -2.7 to -1.3 mm Hg) greater IOP reduction at long-term follow-up, compared with cataract surgery alone. Adding an iStent also safely improved drop-free disease control compared with cataract surgery alone (RR, 1.4; 95% CI, 1.2 to 1.6), but the short-term IOP-lowering effect of the iStent was not sustained. Addition of a CyPass microstent improved drop-free glaucoma control compared with cataract surgery alone (RR, 1.3; 95% CI, 1.1 to 1.5) but was associated with an increased risk of vraision loss. Network meta-analyses supported the direction and magnitude of these results. CONCLUSIONS AND RELEVANCE: Based on data synthesized in Cochrane reviews, some MIGS may afford patients with glaucoma greater drop-free disease control than cataract surgery alone. Among the products currently available, randomized clinical trial data associate the Hydrus with greater drop-free glaucoma control and IOP lowering than the iStent; however, these effect sizes were small.

Comparison of Patient-Reported Functional Recovery From Different Types of Ophthalmic Surgery.

PURPOSE: To characterize and compare patient-reported recovery of function after cataract or glaucoma surgery using a novel visual analog scale. DESIGN: Prospective observational cohort study. METHODS: Daily for 2 weeks and weekly thereafter, patients recovering from trabeculectomy, tube shunt implantation, or cataract extraction (CE) completed a diary-style questionnaire including visual analog scales (VASs; scored 0-100) grading pain and global function. Clinical examination data and medical histories were collected. Generalized estimating equation models evaluated associations between VAS function scores and pain or visual acuity (VA) and compared scores between surgery types. RESULTS: Among 51 participants followed for 12 weeks, tube shunt placement reduced postoperative day 1 (POD1) function by 47 of 100 points vs CE (P = .006), while trabeculectomy did not reduce POD1 function vs CE (P = .33). After CE, trabeculectomy, and tube shunt placement, average VAS function scores increased 13.94 per week for 2 weeks (P < .001), 4.18 per week for 4 weeks (P = .02), and 7.76 per week for 7 weeks (P < .001), respectively. After those timepoints, there was no further significant change. Beyond 2 weeks, pain levels plateaued, and VA returned to baseline across surgery types; function was inversely related to pain or VA only for the first 2 or 4 weeks, respectively. CONCLUSIONS: Patients recovering from cataract and glaucoma surgery report reduced function in the postoperative period. Tube shunt implantation causes greater morbidity than trabeculectomy, and both are associated with slower improvement than CE. Early postoperative function is associated with VA and pain, but neither fully explains reported impairment. A VAS for function may efficiently capture postoperative recovery.

A novel bilayered expanded polytetrafluoroethylene glaucoma implant creates a permeable thin capsule independent of aqueous humor exposure.

The purpose of these studies was to evaluate clinical, functional, and histopathological features of glaucoma drainage implants (GDIs) fabricated from novel, custom-tailored expanded polytetrafluoroethylene (ePTFE). Implants of matching footprints were fabricated from silicone (Control) and novel, bilayered ePTFE. ePTFE implants included: (a) one that inflated with aqueous humor (AH) (High), (b) one that inflated with a lower profile (Low), (c) an uninflated implant not connected to the anterior chamber (Flat), and (d) one filled with material that did not allow AH flow (Filled). All implants were placed in adult New Zealand White rabbits and followed over 1-3 months with clinical exams and intraocular pressure. The permeability of tissue capsules surrounding GDIs was assessed using constant-flow perfusion with fluoresceinated saline at physiologic flow rates. After sacrifice, quantitative histopathological measures of capsule thickness were compared among devices, along with qualitative assessment of cellular infiltration and inflammation. Capsular thickness was significantly reduced in blebs over ePTFE (61.4 ± 53 µm) versus silicone implants (193.6 ± 53 µm, p = .0086). AH exposure did not significantly alter capsular thickness, as there was no significant difference between High and Filled (50.9 ± 29, p = .34) implants. Capsules around ePTFE implants demonstrated permeability with steady-state pressure: flow relationships at physiologic flow rates and rapid pressure decay with flow cessation, while pressure in control blebs increased even at low flow rates and showed little decay. Perfused fluorescein dye appeared beyond the plate border only in ePTFE implants. ePTFE implants are associated with thinner, more permeable capsules compared to silicone implants simulating presently used devices.

Gait in Elderly Glaucoma: Impact of Lighting Conditions, Changes in Lighting, and Fear of Falling.

Purpose: The purpose of this study was to characterize the impact of lighting changes on gait in elderly patients with glaucoma and evaluate whether associations are mediated by fear of falling (FOF). Methods: Gait initiation and parameters measured with the GAITRite Electronic Walkway were captured in normal indoor light, then in dim light, and again in normal light (normal post dim [NPD]). Participants' right and left eye visual fields (VFs) were merged into integrated VF (IVF) sensitivities. FOF was evaluated using a Rasch-analyzed questionnaire. Multivariable regression models evaluated whether IVF sensitivity was associated with lighting-dependent gait changes and if this relationship was mediated by FOF. Results: In 213 participants (mean age = 71.4 years), gait initiation in dim light took longer with more VF damage (P = 0.02). Greater VF damage was associated with slower gait in dim (P < 0.001) and NPD (P = 0.003) lighting, as well as shorter strides (P = 0.02), broader stance (P = 0.003), and more variable stride velocity and length in all lighting (all P < 0.03). When moving from normal to dim lighting, those with more VF damage slowed gait and cadence, shortened stride length, and lengthened double support time (all P < 0.001). Velocity, cadence, and double support time did not return to baseline in NPD lighting (all P < 0.05). Fear of falling did not appear to mediate the relationship between IVF sensitivity and lighting-dependent gait changes. Conclusions: Patients with more VF damage demonstrate gait degradation in extreme or changing lighting, which is not mediated by FOF. Translational Relevance: Quantitative spatiotemporal gait evaluation reveals lighting-associated impairment, supporting patient-reported difficulty with nonideal lighting and equipping providers to advise patients about limitations.

Priorities and Treatment Preferences among Surgery-Naive Patients with Moderate to Severe Open-Angle Glaucoma.

PURPOSE: To explore patients' perspectives and experiences living with moderate to severe glaucoma through qualitative, semistructured interviews and to identify important benefits and risks that patients consider when choosing glaucoma treatments. DESIGN: Semistructured, in-person qualitative interviews with a convenience sample of patients seen at the Johns Hopkins Wilmer Eye Institute. PARTICIPANTS: Surgery-naive patients 21 years of age or older with moderate to severe open-angle glaucoma seeking treatment at the Wilmer Eye Institute's Glaucoma Center of Excellence between August and December 2018. METHODS: We conducted semistructured interviews with patients diagnosed with moderate to severe open-angle glaucoma, focusing on outcomes they prioritize when considering various treatment options. We used Atlas.ti software version 7.5.12 (Scientific Software Development GmbH, Berlin, Germany) to process interview transcripts and the framework approach to analyze the qualitative data. MAIN OUTCOME MEASURES: Patients' descriptions of outcomes important to them in management of moderate to severe open-angle glaucoma. RESULTS: Thirteen men and 15 women with a median age 67 years participated in the study. Compared with the mild-to-moderate glaucoma patients interviewed previously, these participants similarly emphasized (1) activities of daily living, (2) visual symptoms, (3) treatment burden, and (4) intraocular pressure (IOP) control, but unlike patients with milder disease, most related IOP control directly to (5) avoiding disease progression. Almost all (27/28) had also given significant thought to (6) surgical decision making and could describe how they would decide for or against a particular procedure. Finally, two thirds (18/28) expressed (7) significant fear and worry related to their glaucoma diagnosis. CONCLUSIONS: We identified outcomes that matter to patients who are undergoing treatment for moderate to severe glaucoma, many of which may serve as end points in clinical trials, such as functional independence in vision-dependent activities of daily living, avoidance of visual symptoms, and disease progression via maintenance of IOP control. We also observed that these patients have varied and nuanced perspectives on surgical management and its outcomes. It behooves providers and trial designers to consider these in future evaluations of new treatments for moderate to severe glaucoma.

Ab interno trabecular bypass surgery with iStent for open-angle glaucoma.

BACKGROUND: Glaucoma is a leading cause of irreversible blindness worldwide. In early stages, glaucoma results in progressive loss of peripheral (side) vision; in later stages, it results in loss of central vision leading to blindness. Elevated intraocular pressure (IOP) is the only known modifiable risk factor for glaucoma. Minimally invasive glaucoma surgical (MIGS) techniques, such as ab interno trabecular bypass surgery with iStent (Glaukos Corporation, Laguna Hills, CA, USA), have been introduced as a new treatment modality for glaucoma. However, the effectiveness of MIGS on keeping people 'drop-free' (i.e. not having to use eye drops to control IOP) and other outcomes is uncertain. OBJECTIVES: To assess the effectiveness and safety of ab interno trabecular bypass surgery with iStent (or iStent inject) for open-angle glaucoma in comparison to conventional medical, laser, or surgical treatment. SEARCH METHODS: Cochrane Eyes and Vision's Information Specialist searched the following databases on 17 August 2018: the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register; 2018, Issue 7), MEDLINE Ovid, Embase Ovid, the ISRCTN registry, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We applied no date or language restrictions. We searched the reference lists of reports from included studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that had compared iStent or iStent inject to medical therapy, laser treatment, conventional glaucoma surgery (trabeculectomy), or other MIGS procedures. We included RCTs that had compared iStent or iStent inject in combination with phacoemulsification to phacoemulsification alone. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently screened search results, assessed risk of bias, and extracted data from reports of included RCTs using an electronic data collection form. MAIN RESULTS: We included seven RCTs (765 eyes of 764 participants; range per study 33 to 239 participants) that evaluated iStent in people with open-angle glaucoma. We also identified 13 studies that are ongoing or awaiting publications of results. Most participants in the included studies were women (417/764 (55%) participants) and older age (age range: 49 to 89 years). We assessed most trials at unclear or high risk of bias: four trials did not clearly report the method of generating the random sequence or concealing allocation; five were unmasked, open-label studies, which we assessed at high risk of bias for performance and detection bias. All seven trials were funded by the Glaukos Corporation. We graded the certainty of evidence as very low.Four RCTs compared iStent in combination with phacoemulsification to phacoemulsification alone. The summary estimate which we derived from two of the four RCTs suggested that participants in the iStent in combination with phacoemulsification group were 1.38 times more likely to be drop-free between six and 18 months than those in the phacoemulsification alone group (risk ratio (RR) 1.38, 95% confidence interval (CI) 1.18 to 1.63, I2 = 67%). Data from two RCTs also suggested that iStent in combination with phacoemulsification compared to phacoemulsification alone may have offered a small reduction in number of IOP-lowering drops (mean difference (MD) -0.42 drops, 95% CI -0.60 to -0.23). It is uncertain whether there was any difference in terms of mean reduction in IOP from baseline (no meta-analysis).Two RCTs compared treatment with iStent to medical therapy; one of the two trials used the iStent inject. We determined the two trials to be clinically and methodologically heterogeneous and did not conduct a meta-analysis; however, the investigators of both trials reported that over 90% of participants in the treatment groups were drop-free compared to no participants in the medical therapy groups at six to 18 months.One RCT compared treatment with one versus two versus three iStents. There was no difference in terms of participants who were drop-free at 36 months or less; however, at longer follow-up (i.e. at 42 months) participants in the one iStent treatment were less likely to be drop-free than those in the two iStent (RR 0.51, 95% CI 0.34 to 0.75) or three iStent (RR 0.49, 95% CI 0.34 to 0.73) treatment groups. The study did not report the mean change in number of IOP-lowering drops.The type and timing of complications reported varied by RCTs. Similar proportions of participants who underwent treatment with iStent in combination with phacoemulsification and who underwent phacoemulsification alone needed secondary glaucoma surgery. None of RCTs reported findings related to quality of life. AUTHORS' CONCLUSIONS: There is very low-quality evidence that treatment with iStent may result in higher proportions of participants who are drop-free or achieving better IOP control, in the short, medium, or long-term. Results from the 13 studies with results not yet available may clarify the benefits of treatment of people with iStent. Additionally, future MIGS studies should consider measuring quality of life and outcomes that reflect people's ability to perform vision-dependent activities.

Prioritizing outcome preferences in patients with ocular hypertension and open-angle glaucoma using best-worst scaling.

Purpose: To quantify patients' preferences for glaucoma outcomes and use this information to prioritize outcomes that are important to patients. Design: A cross-sectional study using best-worst scaling object case (BWS). Participants: Two hundred seventy-four participants newly diagnosed with ocular hypertension or mild to moderate open angle glaucoma from three private practices and one academic medical center in the United States. Methods: We designed a preference-elicitation survey based on findings from 25 semi-structured, qualitative interviews with patients with glaucoma (reported elsewhere). The survey asked participants to rate the importance of 13 glaucoma outcomes on a Likert scale as a warm-up exercise followed by completion of 13 BWS tasks. For each task, we presented participants a subset of four outcomes from the possible thirteen, and participants chose the most important and least important outcome. Outcomes included in the survey pertain to maintaining ability to perform vision-dependent activities of daily living (e.g., driving), maintaining visual function and perception (e.g., depth perception), minimizing need to take glaucoma drops, not experiencing ocular surface symptoms (e.g., red eyes, teary eyes), and having adequate control of intraocular pressure (IOP). We administered the survey online and analyzed response patterns using conditional logistic regression to determine the relative importance of different outcomes. Main outcome: Ordinal ranking of glaucoma outcomes based on preference weights. Results: Between September 1, 2017 and February 28, 2018, we invited 1035 patients to complete our survey, among whom 274 (26%) responded. Most participants were older than 65 years of age (146/274, 53%) and currently on IOP-lowering drops (179/274, 65%). Participants identified that outcomes with the largest relative importance weight were having "adequate IOP control" and ability to "drive a car during the day," and the outcomes with the smallest relative importance weights were "maintaining appearance of the eye" and "reducing the number of IOP-lowering drops". Conclusions: Determining the relative importance of glaucoma outcomes to patients can help researchers design studies that may better inform clinical and regulatory decision-making. Although IOP is an outcome that researchers often measure in glaucoma clinical trials, patients also prioritized outcomes related to the ability to perform vision-dependent activities such as driving.

Identifying outcomes that are important to patients with ocular hypertension or primary open-angle glaucoma: a qualitative interview study.

Purpose: To explore patients' perspectives and experiences living with glaucoma and identify important benefits and risks that patients consider before electing for new glaucoma treatments, such as minimally invasive glaucoma surgical (MIGS) devices. Design: Semi-structured, in-person qualitative interviews with patients seen at the Johns Hopkins Wilmer Eye Institute. Participants: Adults older than 21 years of age who were suspected or diagnosed with ocular hypertension or mild to moderate primary open-angle glaucoma (POAG) (and thus eligible for treatment with a MIGS procedure) presenting to a glaucoma clinic in Baltimore, Maryland, between May and December 2016. Method: We conducted in-person interviews with patients recently diagnosed with ocular hypertension or POAG. We focused on considerations patients take into account when deciding between different treatments. We used the framework approach to code and analyze the qualitative data. Considerations of special interest to us were those that can be translated into outcomes (or endpoints) in clinical trials. Main outcome measures: Patients' perspectives concerning outcomes that matter to them when managing ocular hypertension or POAG. Results: Ten male and fifteen female patients participated in our study. The median participant age was 69 years (range 47 - 82 years). We identified outcomes that patients expressed as important, which we grouped into four thematic categories: (1) limitations in performing specific vision-dependent activities of daily living; (2) problems with general visual function or perceptions; (3) treatment burden, including ocular adverse events; and (4) intraocular pressure (IOP). All 25 participants expressed some concerns with their ability to perform vision-dependent activities, such as reading and driving. Most (23/25) participants had an opinion about IOP, and among those currently taking ocular hypotensive eye drops, all recognized the relationship between eye drops and IOP. Conclusion: We have identified outcomes that matter to patients who are deciding between different treatments for ocular hypertension and POAG, such as the ability to drive or maintain mobility outside the home. These outcomes will be important in future evaluations of new treatments for glaucoma.