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.

Patient Experience Survey of Anti-Vascular Endothelial Growth Factor 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 USA, the UK, 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 impacts 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 min of travel time (73.7%) and clinic wait time (54.2%). In unadjusted univariable analyses, treatment adherence (vs. nonadherence) 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.

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.

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.

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.

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.

Comparison of optometrist glaucoma referrals against published guidelines.

PURPOSE: To examine if community optometrists follow published guidelines for referral of patients with suspect glaucoma to the hospital eye service. METHODS: A retrospective audit of new optometrist-initiated referrals to the Glaucoma Service at Moorfields Eye Hospital, London was performed. Clinical data from referral letters recorded included evidence of intraocular pressure (IOP) measurement and tonometer used. Referral letter information was compared to 2009 guidelines published jointly by the College of Optometrists and Royal College of Ophthalmologists on referring glaucoma suspect patients. RESULTS: A total of 289 new patients were seen in the Glaucoma Service over a 6 week period from 4th January 2011; a 100% hospital record retrieval rate was obtained. Of these, 114 (39%) were optometrists initiated referrals. Optometrist letters were available for 105 patients. IOP measurements were recorded in 102 (97%); most practitioners used non-contact tonometry (NCT; n = 69; 68%). Practitioners recorded <4 NCT readings per eye (4 readings: n = 3, 4%; 3 readings: n = 42, 61%; 2 readings: n = 6, 9%; 1 reading: n = 18, 26%). Seventy-seven patients (73%) reported with raised IOP as the main referral reason; of these, 33 (43%) were referred with raised IOP in isolation. NCT was the instrument used in the majority of these raised IOP cases (n = 56; 73%). In cases where raised IOP in isolation was the referral reason, 24 (73%) were recorded using NCT; 10 (30%) provided repeat IOP measurement data in the letter. One hundred and two (97%) referred patients attended the hospital appointment. Thirty (29%) were deemed not to have glaucoma, with the remainder diagnosed with ocular hypertension (n = 25; 25%), glaucoma suspect/glaucoma (n = 35, 34%) or narrow angles requiring intervention (n = 12, 12%). Thirty of the 33 patients referred with raised IOP in isolation attended their hospital visit. Ten (33%) of these patients were subsequently discharged. Six (20%) patients had IOP within normal limits when measured with applanation tonometry; all of these patients were kept within the service. CONCLUSIONS: Community optometrists using NCT for measurement should be reminded of the guidelines on number of readings to take and also the value of repeating NCT measures when appropriate. This may help to increase the accuracy of glaucoma suspect referrals to hospital eye service.

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

PURPOSE: To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). DESIGN: Prospective, randomized, controlled 3-year trial. PARTICIPANTS: One hundred sixteen eyes of 116 patients with PDS and OHT. INTERVENTION: Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). MAIN OUTCOME MEASURES: The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. RESULTS: Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). CONCLUSIONS: This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of follow-up.

A national survey of diagnostic tests reported by UK community optometrists for the detection of chronic open angle glaucoma.

PURPOSE: In the UK, the majority of cases of chronic open angle glaucoma are detected by community optometrists following a routine sight test. However, there is potential for variability in case finding strategies used. The aim of this study was to carry out a national web-based survey to determine current diagnostic tests used by optometrists in glaucoma case finding. METHODS: Optometrists on the Association of Optometrists (AOP) electronic database were invited to participate. The survey was open for 16 weeks between April and July 2008. RESULTS: A total of 1875 optometrists were eligible to enter the survey, of which 1264 answered the questions relating to diagnostic equipment. Respondents were asked to indicate their usual method of examining the optic nerve head. Direct ophthalmoscopy only was used by 25% with the majority (62%) using a combination of direct and slit-lamp binocular indirect methods. The vast majority of optometrists (78%) used non-contact tonometry to measure intraocular pressure, with only 16% routinely using a Goldmann or Perkins applanation tonometer. The perimeter most frequently used was either one of the Henson range of instruments (39%) or the Humphrey Field Analyser (22%). A smaller number of optometrists (<5%) had access to more specialised imaging equipment, such as HRT, GDx or OCT. CONCLUSIONS: The results of the survey demonstrate that UK optometrists are well equipped to carry out case finding for chronic open angle glaucoma, although there is a lack of standardisation with respect to equipment used.

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.

Intraocular pressure measurement precision with the Goldmann applanation, dynamic contour, and ocular response analyzer tonometers.

OBJECTIVE: To examine the repeatability and reproducibility of intraocular pressure (IOP) measurements obtained with the Goldmann applanation tonometer (GAT), the Pascal dynamic contour tonometer (DCT; Swiss Microtechnology AG, Port, Switzerland), and the Reichert Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY). A secondary objective was to assess agreement between the devices. DESIGN: Evaluation of technology. PARTICIPANTS: One hundred participants; a mixture of glaucoma suspects, patients, and control volunteers. METHODS: The IOP measurements were obtained with the GAT, DCT, and ORA by 2 of 3 experienced clinicians. Keratometry (CC) measurements were made using the IOLMaster (Carl Zeiss Meditech, AG, Jena, Germany). Three ORA corneal compensated IOP (IOPcc) measurements were obtained before the instillation of anesthesia, after which 2 GAT IOP and 3 DCT IOP measurements were obtained in a randomized order. Central corneal thickness (CCT) was measured using an ultrasound pachymeter. The average ORA corneal response factor (CRF) and the average DCT ocular pulse amplitude (OPA) were determined. Intraobserver variability was calculated by the repeatability coefficient. Interobserver variability (measurement reproducibility) and device agreement were calculated by Bland-Altman analysis (mean difference [bias] and 95% limits of agreement [LoA]). The effect of corneal characteristics (CC, CCT, and CRF) on the IOP measurement differences between tonometers also was determined. MAIN OUTCOME MEASURES: Repeatability and reproducibility of the GAT, DCT, and ORA IOPcc and agreement between tonometers. RESULTS: The repeatability coefficients for GAT, DCT, and ORA were 2.2, 2.3, and 4.3 mmHg, respectively. The intraobserver variability of ORA measurements was shown to be significantly associated with OPA and to a lesser degree with the quality of ORA waveform scans. The interobserver bias (95% LoA) was -0.8 (+/-3.9) mmHg for GAT -0.2 (+/-2.8) mmHg for DCT and -0.3 (+/-3.9) mmHg for ORA IOPcc. On average, GAT under-read both DCT and ORA IOP measurements by approximately 2 mmHg. The IOP measurement differences were better predicted by CRF than CCT. CONCLUSIONS: The DCT shows excellent measurement precision, displaying the best repeatability and reproducibility of the 3 tonometers. Corneal stiffness, as defined using CRF, was associated significantly with agreement between devices. The IOP measurements with each device are not interchangeable. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Barriers perceived by UK-based community optometrists to the detection of primary open angle glaucoma.

PURPOSE: This paper aims to identify the barriers to case-finding for primary open angle glaucoma (POAG) as perceived by community optometrists in the United Kingdom (UK). METHODS: An anonymous, online survey to investigate the current mode of optometric practice for the detection of POAG was developed. The survey included a free-text question relating to barriers to case-finding for the disease. Optometrists on the Association of Optometrists (AOP) electronic database were invited to participate. The survey was open for 16 weeks between April and July 2008. RESULTS: A total of 1680 responses was received to the survey, of which 1293 (77%) answered the free-text question relating to perceived barriers. Eighty-eight per cent of these reported one or more barriers to the detection of glaucoma in the community, most commonly: time constraints limiting the options for repeat testing and lack of financial remuneration to perform the additional tests required. Barriers were less frequently reported in Scotland, with 23.4% of optometrists reporting no barriers compared to only 12% in England, 6% in Northern Ireland and 4% in Wales. CONCLUSION: In general, UK optometrists believed that their ability to detect POAG in the community is hampered by time and financial constraints. However, barriers were significantly fewer in Scotland, where optometrists have different contractual terms of service with the NHS than their counterparts in the rest of the UK.

The quality of optometrists' referral letters for glaucoma.

PURPOSE: The purpose of the study was to evaluate the quality of content of optometrist-initiated glaucoma referral letters arriving at the appointment booking centre at Moorfields Eye Hospital (MEH). METHODS: The minimum standard of information required for an ophthalmologist to determine the appropriateness and urgency of glaucoma suspect referral was determined, and criteria for three standards of referral letter formulated: 'Ideal', 'Acceptable' and 'Fail'. These standards were applied to a prospective review of all optometrist-derived referrals for glaucoma or suspected glaucoma cases arriving in the MEH booking centre over a 4-month period. The contents of each letter were scrutinised and classified based on the criteria within each standard. RESULTS: Forty-nine per cent of referral letters were found to be of 'acceptable' quality, 7%'ideal' quality and the remainder classed as "fail". The main reason for failure was an omission of non-clinical information, including patient and/or referring practice details, although 26% of letters failed to include an optic disc evaluation and 6% failed to provide intra-ocular pressure measurements. Two-thirds of 'acceptable' letters did not reach the 'ideal' standard due to a lack of discussion of risk factors, visual field analysis or recommendations for referral speed. DISCUSSION: The information gleaned from this prospective study indicates a need to improve the quality of optometrists' glaucoma referral letters, particularly with respect to completion of all the items set out on the General Ophthalmic Services (GOS) 18 referral form.

Visual function and fitness to drive.

INTRODUCTION: Driving is recognized to be a visually intensive task and accordingly there is a legal minimum standard of vision required for all motorists. The purpose of this paper is to review the current United Kingdom (UK) visual requirements for driving and discuss the evidence base behind these legal rules. The role of newer, alternative tests of visual function that may be better indicators of driving safety will also be considered. Finally, the implications of ageing on driving ability are discussed. SOURCES OF DATA: A search of Medline and PubMed databases was performed using the following keywords: driving, vision, visual function, fitness to drive and ageing. In addition, papers from the Department of Transport website and UK Royal College of Ophthalmologists guidelines were studied. AREAS OF AGREEMENT, AREAS OF CONTROVERSY, GROWING POINTS, AREAS TIMELY FOR DEVELOPING RESEARCH: Current UK visual standards for driving are based upon historical concepts, but recent advances in technology have brought about more sophisticated methods for assessing the status of the binocular visual field and examining visual attention. These tests appear to be better predictors of driving performance. Further work is required to establish whether these newer tests should be incorporated in the current UK visual standards when examining an individual's fitness to drive.