scholarly journals Real-World Performance of a Self-Operated Home Monitoring System for Early Detection of Neovascular Age-Related Macular Degeneration

2021 ◽  
Vol 10 (7) ◽  
pp. 1355
Author(s):  
Allen C. Ho ◽  
Jeffrey S. Heier ◽  
Nancy M. Holekamp ◽  
Richard A. Garfinkel ◽  
Byron Ladd ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Early Detection ◽  
Monitoring System ◽  
Real World ◽  
Home Monitoring ◽  
Age Related Macular Degeneration ◽  
Home Study ◽  
The Real ◽  
Home Telemonitoring ◽  
Age Related

The real-world performance of a home telemonitoring strategy (ForeseeHome AMD Monitoring System®, Notal Vision, Inc.,Manassas VA, USA) was evaluated and compared to the device arm of the AREDS2-HOME study among patients with intermediate AMD (iAMD) who converted to neovascular AMD (nAMD). All patients with confirmed conversion to nAMD who used the home monitoring system from 10/2009 through 9/2018 were identified by Notal Vision Diagnostic Clinic’s medical records. Selected outcome variables were evaluated, including visual acuity (VA) at baseline and at conversion, and change in visual acuity (VA) from baseline to time of conversion. In total, 8991 patients performed 3,200,999 tests at a frequency of 5.6 ± 3.2 times/week. The 306 eyes that converted from iAMD to nAMD over the study period (a 2.7% annual rate) were included in the analyses. There was a median (interquartile range) change of −3.0 (0.0–(−10.0)) letters among converted eyes, 81% [95% confidence interval (72–88%)] maintained a VA ≥ 20/40 at the time of conversion, while 69% of the conversion detections were triggered by system alerts. The real-world performance of an at-home testing strategy was similar to that reported for the device arm of the AREDS2-HOME study. The home telemonitoring system can markedly increase early detection of conversion to nAMD.

scholarly journals The ‘Real World’ Clinic Measured Visual Acuity Versus the Best Correct Visual Acuity Measurement in Patients Treated for Neovascular Age-Related Macular Degeneration

2021 ◽  
Author(s):  
Obaid Kousha ◽  
Amritpal Chaggar ◽  
Sergio Pagliarini
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
P Value ◽  
The Real ◽  
Age Related ◽  
Clinical Session ◽  
Bland Altman Method ◽  
The Uk

Abstract BACKGROUNDIn ophthalmology clinics, the visual acuity (VA) is usually measured by non-refracting healthcare professionals (HCPs). We compared the ‘real world’ or clinic measured VA versus the best-corrected visual acuity measurement in patients with neovascular age-related macular degeneration (nAMD).METHODSDuring the same clinical session using Early Treatment of Diabetic Retinopathy Study (ETDRS) vision chart, monocular distance VA was measured by non-refracting HCPs in nAMD patients and compared to the monocular distance VA measured by an optometrist with subjective refractive correction (BCVA). The study was powered to detect a difference of >5 ETDRS letters between the groups and for HCP measured VA to detect a BCVA between 6/12 and 6/96 (National Institute of Health and Care Excellence condition of approval of nAMD treatment with licensed drugs in the UK).RESULTSData from 167 patients (324 eyes) were analysed. Absolute mean difference in BCVA versus HCP measured VA was 5.71 (95% confidence interval (CI) 5.10-6.41) ETDRS letters (p-value<0.001). Using Bland-Altman method, limits of agreement between the two groups was found to be between 18.39 and -14.66 ETDRS letters. The prevalence of BCVA between 6/12 and 6/96 was 53.40% (95% CI 47.96-58.83%). In detecting this BCVA bracket, the non-refracting HCP measured VA had a sensitivity of 91.91% (95% CI 87.84-95.97%) and a specificity of 84.77% (95% CI 79.04-90.50%). CONCLUSIONSThe ‘real world’ HCP measured VA was found to have considerable inaccuracy and imprecision when compared to BCVA in nAMD patients. Unreliable VA measurement can have important implications in assessing and treating eye conditions, including nAMD.

scholarly journals Achieving balance in the treatment and monitoring of neovascular age‐related macular degeneration in the real world: lessons from the Netherlands cohort of the AURA study

2018 ◽  
Vol 97 (2) ◽  
Author(s):  
Freekje Asten ◽  
Yvonne Jong‐Hesse ◽  
Janneke J. C. Lith‐Verhoeven ◽  
Frank D. Verbraak ◽  
Johannes G. F. Vromans ◽  
...  
Keyword(s):  
The Netherlands ◽  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
The Real ◽  
Age Related

scholarly journals Eyes that Do Not Meet the Eligibility Criteria of Clinical Trials on Age-Related Macular Degeneration: Proportion of the Real-World Patient Population and Reasons for Exclusion

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jae Hui Kim ◽  
Jong Woo Kim ◽  
Chul Gu Kim
Keyword(s):  
Clinical Trials ◽  
Visual Acuity ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Subretinal Hemorrhage ◽  
Neovascular Amd ◽  
Eligibility Criteria ◽  
Type 3 Neovascularization ◽  
Age Related ◽  
Type 3

Background. To evaluate the proportion of eyes that do not meet the eligibility criteria of clinical trials on neovascular age-related macular degeneration (AMD) and the reasons for exclusion. Methods. This retrospective, observational study included 512 eyes of 463 patients diagnosed with treatment-naïve neovascular AMD. The proportion of eyes that did not meet the eligibility criteria of the Vascular Endothelial Growth Factor Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies were evaluated. The two most common reasons for exclusion were also evaluated in each subtype of neovascular AMD (typical neovascular AMD, polypoidal choroidal vasculopathy (PCV), and type 3 neovascularization). Results. Among the 512 eyes, 229 (44.7%) did not meet the eligibility criteria. In all the included eyes, the most common reasons for exclusion were good or poor visual acuity (169 eyes, 33.0%), followed by the presence of subretinal hemorrhage (47 eyes, 9.5%). Moreover, good or poor visual acuity was the most common reason for exclusion in all three subtypes of neovascular AMD. The second most common reason was a fovea-involving scar or fibrosis in typical neovascular AMD, subretinal hemorrhage in PCV, and other vascular diseases affecting the retina in type 3 neovascularization. Conclusions. Among the included cases, 44.7% did not meet the eligibility criteria for VIEW study, suggesting that the conclusion derived from clinical trials may not directly reflect the real-world outcomes. Additionally, the reasons for ineligibility differed among the different subtypes of neovascular AMD.

scholarly journals Randomized Trial of a Home Monitoring System for Early Detection of Choroidal Neovascularization Home Monitoring of the Eye (HOME) Study

Ophthalmology ◽  
2014 ◽  
Vol 121 (2) ◽  
pp. 535-544 ◽  
Author(s):  
Emily Y. Chew ◽  
Traci E. Clemons ◽  
Susan B. Bressler ◽  
Michael J. Elman ◽  
Ronald P. Danis ◽  
...  
Keyword(s):  
Early Detection ◽  
Randomized Trial ◽  
Choroidal Neovascularization ◽  
Monitoring System ◽  
Home Monitoring ◽  
Home Study

scholarly journals Real-World Experience with Brolucizumab in Wet Age-Related Macular Degeneration: The REBA Study

2021 ◽  
Vol 10 (13) ◽  
pp. 2758
Author(s):  
Alper Bilgic ◽  
Laurent Kodjikian ◽  
Francesc March de Ribot ◽  
Vaishali Vasavada ◽  
Jesus H. Gonzalez-Cortes ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Secondary Outcome ◽  
The Real ◽  
Switch Therapy ◽  
Age Related ◽  
Treatment Naïve ◽  
The Mean

The aim of the present study was to determine the efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) in the real-world setting. The REBA study (real-world experience with brolucizumab in wet AMD) was a retrospective, observational, multicentric study that included 78 consecutive patients (105 eyes), with neovascular AMD, who received brolucizumab therapy. Both treatment-naive and switch-therapy patients were included. Switch therapy was based either on fluid recurrence, fluid recalcitrance, or inability to extend beyond q4/q6. All relevant data were collected. The primary outcome measure was change in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included determination of change in central subfield thickness (CST) and complications. The mean baseline BCVA was 49.4 ± 5.4 letters and 40 ± 3.2 letters, and corresponding mean BCVA gain was +11.9 ± 3.9 letters (p = 0.011) and +10.4 ± 4.8 letters (p = 0.014) in the treatment-naive and switch-therapy groups, respectively. The change in CST was significantly decreased in the treatment-naive (p = 0.021) and the switch-therapy (p = 0.013) groups. The mean follow-up was 10.4 months in both groups. One patient in the switch-therapy group developed vascular occlusion and another a macular hole after the fifth brolucizumab injection. Both patients recovered uneventfully. In conclusion, patients showed a very good anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Two significant untoward events were noted.

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