Rates Of Mean Deviation Change Research Articles

Validation of Rates of Mean Deviation Change as Clinically Relevant End Points for Glaucoma Progression

To investigate whether rates of standard automated perimetry (SAP) mean deviation (MD) over an initial 2-year follow-up period were predictive of events of visual field progression over an extended follow-up. Longitudinal, prospective, observational study. Two hundred forty-six eyes of 168 patients with glaucoma followed up every 6 months for up to 5 years. Patients were required to have a minimum of 5 reliable SAP tests during the first 2 years of follow-up. Events of progression were evaluated using 2 methods: Guided Progression Analysis (GPA; Carl Zeiss Meditec, Inc) and a United States Food and Drug Administration (FDA)-suggested end point. The date of the first test showing progression after the first 2 years was considered to be the event date. Rates of change in SAP MD were calculated for the first 2 years of follow-up, and joint longitudinal survival models were used to assess the risk of faster initial MD loss for subsequent progression based on each event analysis. Risk of having an event of progression based on initial rates of SAP MD change. Fifty-six eye (22.8%) showed an event of progression by the GPA and 51 eyes (20.7%) did so by the FDA end point. Each 0.1-dB/year faster rate of SAP MD loss in the first 2 years was associated with a 26% increase in risk of a GPA progression end point developing (R2= 76%) and 32% risk of an FDA-based end point developing (R2= 83%). A reduction of 30% in the rate of MD change in the first 2 years was associated with a 20% reduction in the cumulative probability of a progression event developing over 5 years of follow-up. Rates of SAP MD change for eyes with glaucoma calculated over the initial 2 years of follow-up were strongly predictive of events of progression over subsequent follow-up. Our findings give support for the use of slopes of MD change as suitable end points of progression in clinical trials. Proprietary or commercial disclosure may be found after the references.

Risk, Prevalence, and Progression of Glaucoma in Eyes With Age-Related Macular Degeneration Treated With Intravitreal Anti–Vascular Endothelial Growth Factor Injections

To examine the risk, prevalence, and progression of glaucoma development in age-related macular degeneration (AMD) eyes receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections compared to controls. Retrospective clinical cohort study. Retrospective review of eyes receiving intravitreal anti-VEGF injections from January 1, 2004, to December 31, 2013, for exudative AMD. Age- and sex-matched control groups of eyes included eyes with nonexudative AMD (NEAMD) and no AMD. Eyes with a diagnosis of glaucoma or glaucoma suspect were reviewed for injection details, type and date of glaucoma diagnosis, glaucoma treatments, standard automated perimetry (SAP), and spectral domain optical coherence tomography (SD-OCT). Qualitative progression was determined by indication of glaucoma progression in provider notes. Quantitative progression was assessed based on change in mean deviation (MD) on SAP, retinal nerve fiber layer thickness on SD-OCT, and intraocular pressure (IOP). There were 707 eyes of 504 patients treated with anti-VEGF injections and 1008 eyes in the NEAMD and no-AMD cohorts. There was no difference in glaucoma or suspect prevalence at initial presentation between eyes treated with injections and NEAMD (6.9% vs 9.7%, P=.22) or no-AMD controls (vs 8.5%, P=.55). There was no difference in cumulative 5-year probability of new glaucoma diagnosis after anti-VEGF injections compared to NEAMD (1.9% vs 1.0%, P=.69) or no-AMD controls (vs 1.6%, P=.88). There was no difference in qualitative progression of glaucoma in the injection cohort vs NEAMD (P=.19) or no-AMD controls (P=.61). The rate of MD change in injection eyes was similar to NEAMD eyes (P=.74) but greater than no-AMD eyes (P=.02). Eyes receiving injections required more topical glaucoma medications compared with NEAMD (P=.03) and more glaucoma laser treatments compared with no-AMD controls (P=.009). Eyes receiving injections did not require more frequent incisional glaucoma surgery compared with NEAMD (21.0% vs 15.0%, P=.95) or no-AMD controls (vs 10.0%, P=.10). Eyes treated with intravitreal anti-VEGF injections for exudative AMD did not have increased risk of developing glaucoma compared with controls. Of those with a glaucoma diagnosis, exudative AMD eyes receiving injections required a greater number of topical glaucoma medications compared with NEAMD eyes and had a greater rate of MD loss than no-AMD controls.

Incidence of Glaucoma Progression and Rate of Visual Field Deterioration in a Cohort of Urban Ghanaians.

The annual incidence of glaucoma progression (9.7%) and rates of visual field mean deviation (MD) change in progressors (-1.02±0.06 dB/y) are high in a small cohort of urban Ghanaians. To report the incidence of glaucoma progression and the rate of visual field deterioration in a small cohort of Ghanaians. One hundred ten subjects (204 eyes) diagnosed with glaucoma at a baseline population-based screening examination were re-examined a mean of 8.3±0.8 years later. Eyes were classified as having progressed if the optic disc alone, visual field alone or both showed significant glaucomatous changes on follow-up. Visual field MD was used to calculate the rate of visual field progression. Progression was observed in 89 (80.9%, 9.7%/year) subjects (130 eyes). Progression occurred in 32 (31.7%, 3.8%/year) subjects by optic disc alone (46 eyes), 38 (44.7%, 5.4%/year) subjects by visual field alone (58 eyes), and 19 (25.0%, 3.0%/year) subjects by both modalities (26 eyes). The average rate of change in MD differed significantly between progressors (-1.02±1.06 dB/y) and nonprogressors (+0.089±0.49 dB/y), P =0.001. The rate of visual field worsening was greater among those who were classified as having progressed by both structure and function (-1.29±0.68 dB/y) and by function alone (-1.21±1.20 dB/y) than by structure alone (-0.55±0.76 dB/y). Progression was significantly associated with older age [odds ratio (OR), 1.42; P <0.001] and higher baseline intraocular pressure (OR, 1.18; P =0.002). Factors associated with rate of MD change were baseline older age (OR, 1.66; P =0.003), higher intraocular pressure (OR, 2.81; P =0.007), better visual field MD (OR, 1.41; P =0.004), and systemic hypertension (OR, 1.15; P =0.029). The incidence and rate of visual field progression are high in this longitudinal study of Ghanaian subjects with glaucoma. The findings may have important clinical and public health policy ramifications.

The Frontloading Fields Study (FFS): Detecting Changes in Mean Deviation in Glaucoma Using Multiple Visual Field Tests Per Clinical Visit.

PurposeTo determine the impact of different numbers of visual field tests per visit for detecting mean deviation changes over time in patients with early glaucoma or suspected glaucoma and to identify a practical approach to maximize change detection.MethodsIntrasession (n = 322) and intersession (n = 323) visual field results for patients with glaucoma or suspected glaucoma were used to model mean deviation change in 10,000 progressing and 10,000 non-progressing computer-simulated patients over time. Variables assessed in the model included follow-up intervals (0.5, 1, or 2 years), reliability rates (70%, 85%, or 100%) and number of visual field tests performed at each visit (one to four).ResultsTwo visual field tests per session compared with one provided higher case detection rates at 2 years (99%–99.8% vs. 34.7%–76.3%, respectively), reduced time to detection (three or four visits vs. six to 10, respectively), and more positive mean deviation score (−4 dB vs. −10 dB, respectively) at the point of mean deviation change identification, especially in the context of unreliable results. Performing two tests per visit offered similar advantages compared with more tests. False positive change detection rates (<2.5%), were similar across all conditions. Patients followed up 6 monthly had less severe mean deviation loss at follow-up compared to 1-year and 2-year follow-up intervals.ConclusionsPerforming two tests per clinical visit at 6 months is practical using SITA-Faster and provides higher detection rates of mean deviation change in comparison with only one test performed per visit and more spaced-out intervals.Translational RelevanceThis model provides guidance for selecting the number of tests per visit to detect mean deviation change.

Variability and Power to Detect Progression of Different Visual Field Patterns

To compare the variability and ability to detect visual field (VF) progression of 24-2, central 12 locations of the 24-2 and 10-2 VF tests in eyes with abnormal VFs. Retrospective, multisite cohort. A total of 52 806 24-2 and 11 966 10-2 VF tests from 7307 eyes from the Glaucoma Research Network database were analyzed. Only eyes with ≥ 5 visits and ≥ 2 years of follow-up were included. Linear regression models were used to calculate the rates of mean deviation (MD) change (slopes), whereas their residuals were used to assess variability across the entire MD range. Computer simulations (n= 10 000) based on real MD residuals of our sample were performed to estimate power to detect significant progression (P < 5%) at various rates of MD change. Time required to detect progression. For all 3 patterns, the MD variability was highest within the-5 to-20 decibel (dB) range and consistently lower with the 10-2 compared with 24-2 or central 24-2. Overall, time to detect confirmed significant progression at 80% power was the lowest with 10-2 VF, with a decrease of 14.6% to 18.5% when compared with 24-2 and a decrease of 22.9% to 26.5% when compared with central 24-2. Time to detect central VF progression was reduced with 10-2 MD compared with 24-2 and C24-2 MD in glaucoma eyes in this large dataset, in part because 10-2 tests had lower variability. These findings contribute to current evidence of the potential value of 10-2 testing in the clinical management of patients with glaucoma and in clinical trial design.

Optical Coherence Tomography Angiography and Visual Field Progression in Primary Angle Closure Glaucoma.

Lower whole enface disc (coefficient: 0.02, P=0.03) and macular vessel densities (coefficient: 0.04, P=0.02) on optical coherence tomography angiography (OCTA) were significantly associated with faster rate of mean deviation (MD) decline. To evaluate the association between OCTA features and prior visual field (VF) progression in primary angle closure glaucoma (PACG). In a cross-sectional study, 46 eyes of 31 PACG patients with 5 reliable VF examinations performed over ≥3 years of follow-up underwent OCTA imaging. Effect of clinical (age, sex, number of antiglaucoma medications, mean, and SD of intraocular pressure during follow-up), optical coherence tomography (average retinal nerve fiber layer and ganglion cell complex thickness) and OCTA (whole enface vessel density of disc and macular scan, deep-layer microvascular dropout) parameters on the rate of MD change was evaluated using linear mixed models. Average (±SD) MD of the baseline VF was -7.4±7.3 dB, and rate of MD change was -0.32±0.29 dB/y. Whole enface vessel density of disc and macular scans was 39.5%±8.1% and 38.7%±4.4%, respectively. Microvascular dropout was noted in 33.3% of the eyes. Multivariate mixed models showed that lower whole enface disc (coefficient: 0.02, P=0.03) and macular vessel densities (coefficient: 0.04, P=0.02) were significantly associated with faster rate of MD decline. Other factors significantly associated with faster progression in multivariate models were older age (coefficient: -0.02, P<0.05) and the presence of systemic hypertension (coefficient: -0.37, P=0.01) and diabetes (coefficient: -0.28, P=0.05). Lower superficial vessel density measured using OCTA was significantly associated with faster VF progression in PACG. In these eyes, OCTA parameters can serve as biomarker suggestive of past VF progression.

Effect of Diabetes Control on Rates of Structural and Functional Loss in Patients with Glaucoma

To investigate the association between levels of diabetes mellitus (DM) control and rates of visual field and retinal nerve fiber layer (RNFL) loss over time in glaucoma. Retrospective cohort study. A total of 351 eyes of 222 patients with type 2 DM with concomitant primary open-angle glaucoma (POAG) or suspected glaucoma extracted from the Duke Glaucoma Registry. All patients had at least 2 reliable standard automated perimetry (SAP) tests, 2 spectral domain OCT (SD-OCT) tests, and 2 glycated hemoglobin (HbA1c) measures over time with a minimum follow-up of 6 months. Values of HbA1c were summarized for each patient as mean, peak, and fluctuation across time. Multivariable linear mixed models were used to estimate the effect of HbA1c on rates of change in SAP mean deviation (MD) and OCT RNFL thickness loss over time while adjusting for various confounding factors. Rates of change in MD and RNFL thickness over time. Subjects had a mean baseline age of 62.5 ± 10.2 years and follow-up time of 6.9 ± 5.1 years. Subjects had an average of 4.8 SAP tests (range, 2-28), 3.6 SD-OCT tests (range, 2-10), and 8.3 HbA1c tests (range, 2-21). Average HbA1c mean was 7.1% ± 1.1% (range, 5.4-11.7), peak HbA1c over time was 8.1% ± 2% (range, 5.5-15.6), and HbA1c fluctuation was 0.6% ± 0.6% (range, 0-4.4). Mean rate of SAP MD changewas-0.09 ± 0.20 decibel/year(median -0.06 decibel/year; interquartile range -0.15 to 0.01 decibel/year), and mean rate of RNFL change was-0.83 ± 0.51 μm/year(median -0.76 μm/year; interquartile range -1.06 to 0.56 μm/year). After adjustment for confounding factors, mean, peak, and fluctuation in HbA1c levels were not significantly associated with rates of MD change over time (P= 0.994, P= 0.689, P= 0.920, respectively), nor were rates of change in RNFL loss over time (P= 0.805, P= 0.575, P= 0.770). We did not find a significant association between diabetes control, as measured by levels of HbA1c, and rates of visual field or RNFL loss over time in individuals with glaucoma or suspected glaucoma.