Patient Experience Survey Of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

INTRODUCTION: Understanding patient perspectives of treatment may improve adherence and outcomes. This study explored real-world patient experiences with anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). METHODS: This multinational, non-interventional, quantitative, cross-sectional, observational survey assessed treatment barriers/burden, patient-reported visual functioning, and treatment satisfaction in DME and nAMD patients in the United States, United Kingdom, Canada, France, Italy, and Spain. Treatment patterns and visual outcomes were extracted from medical charts. Regression models evaluated relationships between adherence, total missed visits, number of anti-VEGF injections and clinical and patient-reported outcomes for visual functioning. Association between treatment satisfaction and aspects of burden were assessed. RESULTS: The survey was completed by 183 DME and 391 nAMD patients. Patients had moderately high vision-related functioning (25-item National Eye Institute Visual Functioning Questionnaire score: mean=74.8) and were satisfied with their current treatment (mean total score: Macular Disease Treatment Satisfaction Questionnaire=59.2; Retinopathy Treatment Satisfaction Questionnaire=61.3). Treatment satisfaction scores were worse with higher time-related impacts of treatment (nAMD/DME), higher impacts on finances and daily life (nAMD), negative impact on employment and lower expectations for treatment effectiveness (DME). Most patients reported ≥1 barrier (66.1% DME, 49.2% nAMD patients) related to treatment (35.0%), clinic (32.6%), and COVID-19 (21.1%). Moreover, 44.9% of patients reported some impairment in activities of daily living. Work absenteeism was observed among >60% of working patients. Nearly one-quarter (24.2%) of patients needed ≥1 day to recover from intravitreal injections; most reported ≥30 minutes of travel time (73.7%) and clinic wait time (54.2%). In unadjusted univariable analyses, treatment adherence (vs non adherence) was related to higher most recent visual acuity (ß = 8.98 letters; CI, 1.34-16.62) and lower odds of visual acuity below driving vision (≤ 69 letters) (OR = 0.50; CI, 0.25-1.00) . CONCLUSION: More durable treatments with reduced frequency of injections/visits may reduce treatment burden and improve patient satisfaction, which may enhance adherence and visual outcomes.

TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2.

PURPOSE: To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A. DESIGN: TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials. PARTICIPANTS: Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older. METHODS: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen. MAIN OUTCOME MEASURES: Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112. RESULTS: Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters [95% confidence interval (CI), +2.1 to +5.4] and +3.3 letters [95% CI, +1.7 to +4.9], respectively; mean difference, +0.4 letters [95% CI, -1.9 to +2.8]) and LUCERNE (adjusted mean change, +5.0 letters [95% CI, +3.4 to +6.6] and +5.2 letters [95% CI, +3.6 to +6.8], respectively; mean difference, -0.2 letters [95% CI, -2.4 to +2.1]). At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing. Ocular AEs in the study eye were comparable between faricimab and aflibercept groups in TENAYA (55.0% and 56.5% of patients, respectively) and LUCERNE (52.9% and 47.5% of patients, respectively) through week 112. CONCLUSIONS: Treat-and-extend faricimab treatment based on nAMD disease activity maintained vision gains through year 2, with most patients achieving extended dosing intervals. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials.

PURPOSE: To evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A inhibitor faricimab versus aflibercept in patients with vein occlusion. DESIGN: Phase 3, global, randomized, double-masked, active comparator-controlled trials: BALATON/COMINO (ClincalTrials.gov identifiers: NCT04740905/NCT04740931; sites: 149/192). PARTICIPANTS: Patients with treatment-naïve foveal center-involved macular edema resulting from branch (BALATON) or central or hemiretinal (COMINO) RVO. METHODS: Patients were randomized 1:1 to faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks for 24 weeks. MAIN OUTCOME MEASURES: Primary end point: change in best-corrected visual acuity (BCVA) from baseline to week 24. Efficacy analyses included patients in the intention-to-treat population. Safety analyses included patients who received ≥ 1 doses of study drug. RESULTS: Enrollment: BALATON, n = 553; COMINO, n = 729. The BCVA gains from the baseline to week 24 with faricimab were noninferior versus aflibercept in BALATON (adjusted mean change, +16.9 letters [95.03% confidence interval (CI), 15.7-18.1 letters] vs. +17.5 letters [95.03% CI, 16.3-18.6 letters]) and COMINO (+16.9 letters [95.03% CI, 15.4-18.3 letters] vs. +17.3 letters [95.03% CI, 15.9-18.8 letters]). Adjusted mean central subfield thickness reductions from the baseline were comparable for faricimab and aflibercept at week 24 in BALATON (-311.4 µm [95.03% CI, -316.4 to -306.4 µm] and -304.4 µm [95.03% CI, -309.3 to -299.4 µm]) and COMINO (-461.6 µm [95.03% CI, -471.4 to -451.9 µm] and -448.8 µm [95.03% CI, -458.6 to -439.0 µm]). A greater proportion of patients in the faricimab versus aflibercept arm achieved absence of fluorescein angiography-based macular leakage at week 24 in BALATON (33.6% vs. 21.0%; nominal P = 0.0023) and COMINO (44.4% vs. 30.0%; nominal P = 0.0002). Faricimab was well tolerated, with an acceptable safety profile comparable with aflibercept. The incidence of ocular adverse events was similar between patients receiving faricimab (16.3% [n = 45] and 23.0% [n = 84] in BALATON and COMINO, respectively) and aflibercept (20.4% [n = 56] and 27.7% [n = 100], respectively). CONCLUSIONS: These findings demonstrate the efficacy and safety of faricimab, a dual Ang-2/VEGF-A inhibitor, in patients with macular edema secondary to retinal vein occlusion. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale.

Purpose: Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO). Design: Two identically designed global, randomized, double-masked, active comparator-controlled studies. Participants: Anti-VEGF treatment-naive patients with branch, central, or hemiretinal RVO. Methods: Patients were randomized to 6 monthly injections of faricimab 6.0 mg or aflibercept 2.0 mg. From weeks 24 to 72, all patients received faricimab 6.0 mg administered in up to 16-week intervals using an automated treatment algorithm to generate a treat-and-extend-based personalized treatment interval dosing regimen. Personalized treatment interval adjustments were based on changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA). Main Outcome Measures: Primary end point was noninferiority of faricimab versus aflibercept in mean change from baseline in BCVA (week 24; noninferiority margin: 4 letters). Secondary end points (weeks 0-24) were mean change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire 25 composite score; proportion of patients gaining or avoiding loss of ≥ 15/≥ 10/≥ 5/> 0 letters. Secondary end points (weeks 24-72) were treatment durability (week 68); continuation of weeks 0 to 24 end points. Ocular/nonocular adverse events will be assessed. Results: In total, 1282 patients across 22 countries were enrolled (BALATON, 553 patients, 149 centers; COMINO, 729 patients, 193 centers). Conclusions: Using a novel automated interval algorithm, BALATON/COMINO will evaluate the efficacy and safety of faricimab for ME secondary to RVO and provide key insights into how to personalize treatment. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Efficacy, durability, and safety of faricimab in patients from Asian countries with neovascular age-related macular degeneration: 1-Year subgroup analysis of the TENAYA and LUCERNE trials.

PURPOSE: To evaluate 1-year efficacy, durability, and safety of faricimab among patients from Asian countries in the TENAYA/LUCERNE trials of neovascular age-related macular degeneration (nAMD). METHODS: Treatment-naïve patients with nAMD were randomly assigned (1:1) to faricimab 6.0 mg up to every 16 weeks (Q16W), based on disease activity at weeks 20 and 24, or aflibercept 2.0 mg Q8W. The primary endpoint was change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. RESULTS: In the pooled TENAYA/LUCERNE trials, there were 120 (9.0%) and 1209 (91.0%) patients in the Asian (faricimab n = 61; aflibercept n = 59) and non-Asian country (faricimab n = 604; aflibercept n = 605) subgroups, respectively. In the Asian country subgroup, mean BCVA change from baseline at the primary endpoint visits was 7.1 (95% CI, 4.3-9.8) letters with faricimab and 7.2 (4.4-10.0) letters with aflibercept. In non-Asian country patients, mean vision gains were 6.1 (5.2-7.1) and 5.7 (4.8-6.7) letters with faricimab and aflibercept, respectively. At week 48, 59.6% of Asian country patients in the faricimab group achieved Q16W dosing (vs. 43.9% non-Asian) and 91.2% achieved ≥ Q12W dosing (vs. 77.5% non-Asian). Central subfield thickness reductions were similar between the subgroups, with meaningful and similar reductions from baseline observed at the primary endpoint visits and over time. Faricimab was well tolerated in both subgroups, with an acceptable safety profile. CONCLUSION: Consistent with the global TENAYA/LUCERNE findings, faricimab up to Q16W showed sustained visual and anatomical benefits in patients with nAMD from Asian and non-Asian countries. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03823287 (TENAYA); NCT03823300 (LUCERNE). Date of registration: January 30, 2019.

TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration.

Purpose: To describe the design and rationale of the phase 3 TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) trials that aimed to assess efficacy, safety, and durability of faricimab, the first bispecific antibody for intraocular use, which independently binds and neutralizes both angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A) versus aflibercept in patients with neovascular age-related macular degeneration (nAMD). Design: Identical, global, double-masked, randomized, controlled, phase 3 clinical trials. Participants: Adults with treatment-naïve nAMD. Methods: These trials were designed to evaluate patients randomized to receive faricimab 6.0 mg up to every 16 weeks after 4 initial every-4-week doses or aflibercept 2.0 mg every 8 weeks after 3 initial every-4-week doses. The initial doses in the faricimab arm were followed by individualized fixed treatment intervals up to week 60, based on disease activity assessment at weeks 20 and 24, guided by central subfield thickness, best-corrected visual acuity (BCVA), and investigator assessment. The primary efficacy end point was BCVA change from baseline averaged over weeks 40, 44, and 48. Secondary end points included the proportion of patients receiving every-8-week, every-12-week, and every-16-week faricimab and anatomic outcomes. Safety outcomes included incidence and severity of ocular and nonocular adverse events. From week 60, faricimab-treated patients followed a personalized treatment interval (PTI), a novel protocol-driven treat-and-extend regimen with interval adjustment from every 8 weeks to every 16 weeks based on individualized treatment response measured by anatomic criteria, functional criteria, and investigator assessment of patients' disease activity. Main Outcome Measures: Rationale for trial design and PTI approach. Results: The TENAYA and LUCERNE trials were the first registrational trials in nAMD to test fixed dosing regimens up to every 16 weeks based on patients' disease activity in year 1 and incorporate a PTI paradigm during year 2. The PTI approach was designed to tailor treatment intervals to individual patient needs, to reflect clinical practice treatment practice, and to reduce treatment burden. Conclusions: The innovative trial design rationale for the TENAYA and LUCERNE trials included maximizing the benefits of angiopoietin-2 blockade through dosing up to every 16 weeks and PTI regimens based on patients' disease activity while fulfilling health authority requirements for potential registrational efforts.

Analysing barriers to service improvement using a multi-level theory of innovation: the case of glaucoma outpatient clinics.

The development and implementation of innovation by healthcare providers is understood as a multi-determinant and multi-level process. Theories at different analytical levels (i.e. micro and organisational) are needed to capture the processes that influence innovation by providers. This article combines a micro theory of innovation, actor-network theory, with organisational level processes using the 'resource based view of the firm'. It examines the influence of, and interplay between, innovation-seeking teams (micro) and underlying organisational capabilities (meso) during innovation processes. We used ethnographic methods to study service innovations in relation to ophthalmology services run by a specialist English NHS Trust at multiple locations. Operational research techniques were used to support the ethnographic methods by mapping the care process in the existing and redesigned clinics. Deficiencies in organisational capabilities for supporting innovation were identified, including manager-clinician relations and organisation-wide resources. The article concludes that actor-network theory can be combined with the resource-based view to highlight the influence of organisational capabilities on the management of innovation. Equally, actor-network theory helps to address the lack of theory in the resource-based view on the micro practices of implementing change.

Developing standards for the development of glaucoma virtual clinics using a modified Delphi approach.

PURPOSE: To obtain consensus opinion for the development of a standards framework for the development and implementation of virtual clinics for glaucoma monitoring in the UK using a modified Delphi methodology. METHODS: A modified Delphi technique was used that involved sampling members of the UK Glaucoma and Eire Society (UKEGS). The first round scored the strength of agreement to a series of standards statements using a 9-point Likert scale. The revised standards were subjected to a second round of scoring and free-text comment. The final standards were discussed and agreed by an expert panel consisting of seven glaucoma subspecialists from across the UK. A version of the standards was submitted to external stakeholders for a 3-month consultation. RESULTS: There was a 44% response rate of UKEGS members to rounds 1 and 2, consisting largely of consultant ophthalmologists with a specialist interest in glaucoma. The final version of the standards document was validated by stakeholder consultation and contains four sections pertaining to the patient groups, testing methods, staffing requirements and governance structure of NHS secondary care glaucoma virtual clinic models. CONCLUSIONS: Use of a modified Delphi approach has provided consensus agreement for the standards required for the development of virtual clinics to monitor glaucoma in the UK. It is anticipated that this document will be useful as a guide for those implementing this model of service delivery.

Example of monitoring measurements in a virtual eye clinic using 'big data'.

AIM: To assess the equivalence of measurement outcomes between patients attending a standard glaucoma care service, where patients see an ophthalmologist in a face-to-face setting, and a glaucoma monitoring service (GMS). METHODS: The average mean deviation (MD) measurement on the visual field (VF) test for 250 patients attending a GMS were compared with a 'big data' repository of patients attending a standard glaucoma care service (reference database). In addition, the speed of VF progression between GMS patients and reference database patients was compared. Reference database patients were used to create expected outcomes that GMS patients could be compared with. For GMS patients falling outside of the expected limits, further analysis was carried out on the clinical management decisions for these patients. RESULTS: The average MD of patients in the GMS ranged from +1.6dB to -18.9dB between two consecutive appointments at the clinic. In the first analysis, 12 (4.8%; 95% CI 2.5% to 8.2%) GMS patients scored outside the 90% expected values based on the reference database. In the second analysis, 1.9% (95% CI 0.4% to 5.4%) GMS patients had VF changes outside of the expected 90% limits. CONCLUSIONS: Using 'big data' collected in the standard glaucoma care service, we found that patients attending a GMS have equivalent outcomes on the VF test. Our findings provide support for the implementation of virtual healthcare delivery in the hospital eye service.

Quality of Life in the Tube Versus Trabeculectomy Study.

PURPOSE: To report the vision-specific quality-of-life (QoL) outcomes in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. METHODS: Setting: Seventeen clinical centers. STUDY POPULATION: Patients 18-85 years of age with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. INTERVENTIONS: Tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with MMC. MAIN OUTCOME MEASURES: Vision-specific QoL using the NEI VFQ-25 and estimation of minimally important differences (MID) were the main outcome measures. Cross-sectional distribution- and anchor-based approaches were used to estimate MID. Clinical anchor measures included the mean deviation (MD) and logMAR visual acuity (VA) measurements. Clinically significant changes in anchor were defined as ≥2 dB MD and ≥0.2 logMAR. RESULTS: No significant differences in composite scores were observed between treatment groups, and no significant change in scores were seen over time. Mean (SD; range) values of clinical anchors at baseline were -16.6 (9.3; -32 to -0.5) dB for the surgical eye and 0.2 (0.3; -0.1 to 1.3) logMAR VA in the better-vision eye. For anchor-based cross-sectional analysis, composite score MID (95% CI) was 6.3 (4.6-7.9) for better-eye VA and 1.4 (0.9-1.9) for surgical eye MD. Distribution-based MID for the composite score was 6.0. CONCLUSIONS: Trabeculectomy and tube shunt surgery had similar impact on patient-reported vision-specific QoL measured using the NEI VFQ-25. In this cohort of patients with advanced glaucoma, MIDs varied depending on the clinical anchor used. Distribution-based MIDs corresponded well with anchor-based MIDs based on VA measures. The MID values reported here may be useful for others wishing to interpret NEI VFQ-25 scores in their advanced glaucoma patient cohort.

Virtual clinics in glaucoma care: face-to-face versus remote decision-making.

BACKGROUND/AIMS: To examine the agreement in clinical decisions of glaucoma status made in a virtual glaucoma clinic with those made during a face-to-face consultation. METHODS: A trained nurse and technicians entered data prospectively for 204 patients into a proforma. A subsequent face-to-face clinical assessment was completed by either a glaucoma consultant or fellow. Proformas were reviewed remotely by one of two additional glaucoma consultants, and 12 months later, by the clinicians who had undertaken the original clinical examination. The interobserver and intraobserver decision-making agreements of virtual assessment versus standard care were calculated. RESULTS: We identified adverse disagreement between face-to-face and virtual review in 7/204 (3.4%, 95% CI 0.9% to 5.9%) patients, where virtual review failed to predict a need to accelerated follow-up identified in face-to-face review. Misclassification events were rare, occurring in 1.9% (95% CI 0.3% to 3.8%) of assessments. Interobserver κ (95% CI) showed only fair agreement (0.24 (0.04 to 0.43)); this improved to moderate agreement when only consultant decisions were compared against each other (κ=0.41 (0.16 to 0.65)). The intraobserver agreement κ (95% CI) for the consultant was 0.274 (0.073 to 0.476), and that for the fellow was 0.264 (0.031 to 0.497). CONCLUSIONS: The low rate of adverse misclassification, combined with the slowly progressive nature of most glaucoma, and the fact that patients will all be regularly reassessed, suggests that virtual clinics offer a safe, logistically viable option for selected patients with glaucoma.

Standing Balance Stability and the Effects of Light Touch in Adults With Profound Loss of Vision-An Exploratory Study.

PURPOSE: We evaluated the postural stability of adults with inherited profound vision loss and examined the effects of touch on their balance control. METHODS: A total of 11 severely-sight impaired patients (mean [SD] age, 51.6 [5.3] years) and 11 control subjects (mean age, 49.7 [5.3] years) participated. Postural stability was measured using a force-balance platform eyes open/closed on a firm/foam surface under 3 test conditions: no touch, light touch, and unrestricted touch (UT), where "touch" involved placing their index finger on a rigid table. Average magnitude of center of foot pressure displacement was calculated. A somatosensory ratio (SR) was used to evaluate the somatosensory contribution to balance. A repeated measures ANOVA was used to investigate the effects of touch on standing balance. RESULTS: Patients had a significantly increased SR compared to control subjects (mean [SD] SR controls = 1.2 [0.2], patients = 1.9 [0.5]; P < 0.01). There was a significant effect of touch, vision, and surface on balance control ("touch" F = 68.1, P < 0.01; "vision" F = 20.1, P < 0.01; "surface" F = 200.8, P < 0.01). Light touch attenuated sway in patients and controls. The effects were greater in controls when their vision was removed, and greater in patients when their somatosensory system was disrupted. Light touch was as effective as UT in attenuating sway. CONCLUSIONS: The results of this exploratory study suggest that patients with severe sight impairment show an increased somatosensory contribution to balance control compared to their normally sighted counterparts. Light touch significantly reduces sway amplitude in severely sight impaired adults when standing on the foam surface, that is, when the somatosensory system is perturbed.

Applanation tonometry: interobserver and prism agreement using the reusable Goldmann applanation prism and the Tonosafe disposable prism.

PURPOSE: To evaluate the levels of agreement between the standard reusable prism and a disposable prism, and to examine the agreement between ophthalmologists, nursing and technical staff when measuring intraocular pressure (IOP) using the Goldmann applanation tonometer. METHODS: Three hundred eyes of 300 patients were recruited. IOP measurements were made in a randomised order by three observer groups consisting of ophthalmologists and ophthalmic technicians/nurses taken from a pool of clinicians working within a busy outpatient clinic. Agreement was calculated by Bland-Altman analysis, showing the mean difference and 95% limits of agreement (LoA) of measurements. RESULTS: The mean difference between the reusable and disposable prism IOP measurements was <0.5 mm Hg. The LoA ranged from ±3.1 to ±4.9 mm Hg, depending on the observer group. The interobserver variability was <1 mm Hg across all observer groups; the LoA was slightly higher for observers using the reusable prism (range between ±4.3 and ±5.6 mm Hg) compared with using the disposable prism (range between ±3.7 and ±5.4 mm Hg) across observer groups. CONCLUSIONS: There is an acceptable agreement between IOP measurements made with the reusable Goldmann tonometer prism and the disposable Tonosafe prism. Interobserver variability in IOP measurements within an outpatient setting is larger than that found within a research setting, and may be of a level that impacts on clinical decision-making.

Interobserver agreement using Goldmann applanation tonometry and dynamic contour tonometry: comparing ophthalmologists, nurses and technicians.

PURPOSE: To compare agreement between ophthalmologists and non-ophthalmologists (nurses and ophthalmic technicians) when measuring the intraocular pressure (IOP) using Goldmann applanation tonometry (GAT) and Pascal dynamic contour tonometry (DCT). METHODS: Patients attending for their routine glaucoma outpatient appointment were invited to participate. IOP was measured in one eye by either two ophthalmologists (observer group 1), two non-ophthalmologists (observer group 2) or one ophthalmologist and one non-ophthalmologist (observer group 3). All were experienced in using GAT and some experienced in using the DCT. The order of tonometer and staff was randomised. Agreement was calculated by Bland-Altman analysis, with the mean difference and 95% limits of agreement (LoA) of measurements calculated for each observer group. RESULTS: One hundred eyes were measured within each observer group. The mean difference (95% LoA) in IOP measurements were GAT: group 1=-0.20 (4.9) mm Hg, group 2=0.6 (5.4) mm Hg and group 3=0.0 (3.7) mm Hg; DCT: group 1=0.8 (7.7) mm Hg, group 2=0.3 (4.2) and group 3=0.0 (5.2) mm Hg. The DCT consistently over-read the GAT for all observer groups. DISCUSSION/CONCLUSIONS: Ophthalmologists show good levels of agreement with each other when using GAT, while technicians/nursing staff show better agreement when using the DCT. The DCT may be a better tonometer to use if permanently delegating IOP measurements to non-ophthalmologists, but measurements cannot be interchanged with the GAT.

Qualitative investigation of patients' experience of a glaucoma virtual clinic in a specialist ophthalmic hospital in London, UK.

OBJECTIVES: To explore how patients felt about delivery of care in a novel technician-delivered virtual clinic compared with delivery of care in a doctor-delivered model. DESIGN: A qualitative investigation using one-to-one interviews before and after patients' appointments at either the standard outpatient glaucoma clinic or the new technician-delivered virtual glaucoma clinic (Glaucoma Screening and Stable Monitoring Service, GSMS). SETTING: A glaucoma clinic based in a tertiary ophthalmic specialist hospital in London. PARTICIPANTS: 43 patients (38 Caucasian, 5 African/Afro-Caribbean) were interviewed prior to their glaucoma appointment; 38 patients were interviewed between 4 and 6 weeks after their appointment. Consecutive patients were identified from patient reception lists and telephoned prior to their appointment inviting them to participate. RESULTS: Trust in the patient-provider relationship emerged as a key theme in patients' acceptance of not being seen in a traditional doctor-delivered service. Patients who were well informed regarding their glaucoma status and low risk of progression to sight loss were more accepting of the GSMS. Patients valued the reassurance received through effective communication with their healthcare practitioner at the time of their appointment. CONCLUSIONS: This study suggests that patients are accepting of moving to a model of service delivery whereby the doctor is removed from the consultation as long as they are informed about the status of their condition and reassured by the interaction with staff they meet. This study highlights the importance of patient engagement when introducing new models of service delivery.

Experiences with developing and implementing a virtual clinic for glaucoma care in an NHS setting.

BACKGROUND: This article describes the development of a virtual glaucoma clinic, whereby technicians collect information for remote review by a consultant specialist. DESIGN AND METHODS: This was a hospital-based service evaluation study. Patients suitable for the stable monitoring service (SMS) were low-risk patients with "suspect", "early"-to-"moderate" glaucoma who were deemed stable by their consultant care team. Three technicians and one health care assistant ran the service. Patients underwent tests in a streamlined manner in a dedicated clinical facility, with virtual review of data by a consultant specialist through an electronic patient record. MAIN OUTCOME MEASURE: Feasibility of developing a novel service within a UK National Health Service setting and improvement of patient journey time within the service were studied. RESULTS: Challenges to implementation of virtual clinic include staffing issues and use of information technology. Patient journey time within the SMS averaged 51 minutes, compared with 92 minutes in the glaucoma outpatient department. Patient satisfaction with the new service was high. CONCLUSION: Implementing innovation into existing services of the National Health Service is challenging. However, the virtual clinic showed an improved patient journey time compared with that experienced within the general glaucoma outpatient department. There exists a discrepancy between patient management decisions of reviewers, suggesting that some may be more risk averse than others when managing patients seen within this model. Future work will assess the ability to detect progression of disease in this model compared with the general outpatient model of care.

Missed Hospital Appointments of Patients Receiving Ranibizumab Therapy for Neovascular Age-Related Macular Degeneration.

INTRODUCTION: The aim of this study was to investigate the frequency and duration of missed hospital appointments (MHAs) in a consecutive cohort of patients treated with ranibizumab for neovascular age-related macular degeneration (nAMD) and to assess their impact on outcomes of therapy in a real-world clinical setting. METHODS: Retrospective, cross-sectional study of consecutive patients attending medical retina clinics for nAMD treatment with ranibizumab. RESULTS: Seventy-eight eyes of 78 patients met the inclusion criteria for data analysis. Mean age was 78 years with mean follow-up of 27 months. Mean visual acuity (VA) was 52 ± 16 letters at baseline, 56 ± 17 letters at year 1 and 58 ± 16 letters at year 2. At the end of the second year, 90% of the patients had lost <15 letters, 26% had gained ≥15 letters and 10% had lost ≥15 letters. Nineteen patients had at least one MHA (24%) over 2 years. There were 26 MHA episodes in total leading to a median duration of 79 days (range 35-159) between attended hospital visits. None of these MHAs occurred during the first 3 months after treatment initiation. Mean VA and central retinal thickness difference between 2 years and baseline for the MHA group was not statistically different compared with the non-MHA group. CONCLUSIONS: Our data suggest that MHA may be a relatively common occurrence in AMD treatment clinics, but good outcomes of treatment can be achieved over 2 years despite missed hospital visits if patients are reviewed on average six times in the first year after an initial loading phase of three injections and nine times in the second year of treatment.

The Argus II prosthesis facilitates reaching and grasping tasks: a case series.

BACKGROUND: To evaluate the reach-to-grasp performance of patients fitted with an epiretinal artifical retina device. METHODS: This was a hospital-based case series consisting of six patients fitted with the Argus II (Second Sight Medical Products Inc, California, USA) retinal prosthesis. Participants were asked to reach out and pick up a high-contrast cuboid object with the prosthesis in the 'On', 'Off' or 'Scrambled' setting presented in a randomised order. The 'Scrambled' setting consisted of a random, scattered signal presented to the prosthesis. The session was repeated after a 4-6 week period. Hand movements were measured using motion detection cameras. The number of successful object grasps was calculated. RESULTS: The number of successful grasps was greater with the prosthesis in the 'On' setting (visit 1: median [interquartile range] percentage success: 'Off' = 0 [0 to 50]%, 'On' = 69 [67 to 95]%, 'Scrambled' = 59 [42 to 95]%; Friedman Chi-squared test statistic 6.5, p = 0.04; visit 2 median [IQR] percentage success: 'Off' = 0 [0 to 25]%, 'On' = 69 [53 to 100]%, 'Scrambled' = 28 [13 to 63]%; Friedman Chi-squared test statistic 8.4, p= 0.02). CONCLUSIONS: The use of an electronic retinal prosthesis facilitates reach-and-grasp performance. Further work should explore how performance can be improved with targeted rehabilitation.

Biomechanical parameters of the cornea measured with the Ocular Response Analyzer in normal eyes.

BACKGROUND: To evaluate the relationships between Reichert Ocular Response Analyzer (ORA) parameters corneal hysteresis (CH) and corneal response factor (CRF) and ocular dimensions, age and intraocular pressure. METHODS: Two hundred and twelve eyes of 212 participants with no ocular pathology had CH and CRF measured with the ORA. Intraocular pressure (IOP) was measured with the Dynamic Contour tonometer and central corneal thickness (CCT) was also evaluated. Partial least squares linear regression (PLSLR) analyses were performed to examine the relationships between each response variable, CH and CRF, and the predictor variables age, corneal curvature (CC), axial length (AL), CCT and IOP. RESULTS: CH was positively associated with CCT and negatively associated with age (scaled coefficients: CCT 0.62, p < 0.0001; age -0.55, p <0.0001; r2 = 0.25). CRF was positively associated with CCT and DCT IOP and negatively associated with age and AL (scaled coefficients: CCT 0.89, p < 0.0001; DCT IOP 0.46, p < 0.01; age - 0.60, p < 0.0001; AL -0.37, p < 0.01; r2 = 0.43). There was no significant association between CC and CH or CRF. CONCLUSIONS: The study suggests that age and CCT are strongly associated with CH and CRF, and that the latter is also influenced by AL and IOP. However, the variables studied could explain only 25% and 43% of the measured variation in CH and CRF, respectively, suggesting other factors also affect the values of these measurements.