A Deep Learning Approach to Improve Retinal Structural Predictions and Aid Glaucoma Neuroprotective Clinical Trial Design
The deep learning models were able to accurately estimate both macula GCIPL and ONH RNFL hemiretinal thickness. Using an internal control based on these model predictions may help reduce clinical trial sample size requirements and facilitate investigation of new glaucoma neuroprotection therapies.
KEY FINDINGS: The deep learning models were able to accurately estimate both macula GCIPL and ONH RNFL hemiretinal thickness. Using an internal control based on these model predictions may help reduce clinical trial sample size requirements and facilitate investigation of new glaucoma neuroprotection therapies.
BACKGROUND: Aim of the study is to investigate the efficacy of a deep learning regression method to predict macula ganglion cell-inner plexiform layer (GCIPL) and optic nerve head (ONH) retinal nerve fiber layer (RNFL) thickness for use in glaucoma neuroprotection clinical trials. Glaucoma patients with good quality macula and ONH scans enrolled in 2 longitudinal studies, the African Descent and Glaucoma Evaluation Study and the Diagnostic Innovations in Glaucoma Study.
DETAILS: Spectralis macula posterior pole scans and ONH circle scans on 3327 pairs of GCIPL/RNFL scans from 1096 eyes (550 patients) were included. Participants were randomly distributed into a training and validation dataset (90%) and a test dataset (10%) by participant. Networks had access to GCIPL and RNFL data from one hemiretina of the probe eye and all data of the fellow eye. The models were then trained to predict the GCIPL or RNFL thickness of the remaining probe eye hemiretina. Mean absolute error (MAE) and squared Pearson correlation coefficient (r2) were used to evaluate model performance. The deep learning model was able to predict superior and inferior GCIPL thicknesses with a global r2 value of 0.90 and 0.86, r2 of mean of 0.90 and 0.86, and mean MAE of 3.72 μm and 4.2 μm, respectively. For superior and inferior RNFL thickness predictions, model performance was slightly lower, with a global r2 of 0.75 and 0.84, r2 of mean of 0.81 and 0.82, and MAE of 9.31 μm and 8.57 μm, respectively. There was only a modest decrease in model performance when predicting GCIPL and RNFL in more severe disease. Using individualized hemiretinal predictions to account for variability across patients, we estimate that a clinical trial can detect a difference equivalent to a 25% treatment effect over 24 months with an 11-fold reduction in the number of patients compared to a conventional trial.
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Source: Christopher, M., Hoseini, P., Walker, E., et al. (2023). A Deep Learning Approach to Improve Retinal Structural Predictions and Aid Glaucoma Neuroprotective Clinical Trial Design. Ophthalmology Glaucoma. 2023; 6(2): 147-159. Published: May, 2023. DOI: 10.1016/j.ogla.2022.08.014.
Trends in the Prevalence and Treatment of Diabetic Macular Edema and Vision-Threatening Diabetic Retinopathy Among Commercially Insured Adults Aged <65 Years
Annual claims for DME or VTDR and anti-VEGF injections increased whereas those for laser photocoagulation decreased among commercially insured adults with diabetes.
KEY FINDINGS: Annual claims for DME or VTDR and anti-VEGF injections increased whereas those for laser photocoagulation decreased among commercially insured adults with diabetes.
BACKGROUND: Examine the 10-year trend in the prevalence and treatment of diabetic macular edema (DME) and vision-threatening diabetic retinopathy (VTDR) among commercially insured adults with diabetes.
DETAILS: Authors analyzed the 10-year trend (2009- 2018) in health care claims for adults aged 18- 64 years using the IBM MarketScan Database, a national convenience sample of employer-sponsored health insurance. We included patients continuously enrolled in commercial fee-for-service health insurance for 24 months who had a diabetes ICD-9/10-CM code on one or more inpatient or two or more different-day outpatient claims in the index year or previous calendar year. We used diagnosis and procedure codes to calculate the annual prevalence of patients with one or more claims for 1) any DME, 2) either DME or VTDR, and 3) antivascular endothelial growth factor (anti-VEGF) injections and laser photocoagulation treatment, stratified by any DME, VTDR with DME, and VTDR without DME. Authors calculated the average annual percent change (AAPC). From 2009 to 2018, there was an increase in the annual prevalence of patients with DME or VTDR (2.1% to 3.4%; AAPC 7.5%; P < 0.001) and any DME (0.7% to 2.6%; AAPC 19.8%; P < 0.001). There were sex differences in the annual prevalence of DME or VTDR and any DME, with men having a higher prevalence than women. Annual claims for anti-VEGF injections increased among patients with any DME (327%) and VTDR with DME (206%); laser photocoagulation decreased among patients with any DME (- 68%), VTDR with DME (- 54%), and VTDR without DME (- 62%).
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Copyright © The American Diabetes Association. All rights reserved.
Source: Lundeen, E. A., Kim, M., Rein, D. B., et al. (2023). Trends in the Prevalence and Treatment of Diabetic Macular Edema and Vision-Threatening Diabetic Retinopathy Among Commercially Insured Adults Aged 65 Years. Diabetes Care . 2023; 46(4): 687- 696. Published: April, 2023. DOI: 10.2337/dc22-1834.
Increasing Threat of Spread of Antimicrobial-resistant Fungus in Healthcare Facilities
C. auris case counts may also have increased because of enhanced efforts to detect cases, including increased colonization screening, a test to see if someone has the fungus somewhere on their body but does not have an infection or symptoms of infection.
KEY FINDINGS: C. auris case counts have increased for many reasons, including poor general infection prevention and control (IPC) practices in healthcare facilities. Case counts may also have increased because of enhanced efforts to detect cases, including increased colonization screening, a test to see if someone has the fungus somewhere on their body but does not have an infection or symptoms of infection. The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on healthcare and public health systems during the COVID-19 pandemic.
BACKGROUND: Candida auris (C. auris), an emerging fungus considered an urgent antimicrobial resistance (AR) threat, spread at an alarming rate in U.S. healthcare facilities in 2020-2021, according to data from the Centers for Disease Control and Prevention (CDC) published in the Annals of Internal Medicine. Equally concerning was a tripling in 2021 of the number of cases that were resistant to echinocandins, the antifungal medicine most recommended for treatment of C. auris infections. In general, C. auris is not a threat to healthy people. People who are very sick, have invasive medical devices, or have long or frequent stays in healthcare facilities are at increased risk for acquiring C. auris. CDC has deemed C. auris as an urgent AR threat, because it is often resistant to multiple antifungal drugs, spreads easily in healthcare facilities, and can cause severe infections with high death rates.
DETAILS: "The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control," said CDC epidemiologist Dr. Meghan Lyman, lead author of the paper.
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As further explained in the article, C. auris has spread in the United States since it was first reported in 2016, with a total of 3,270 clinical cases (in which infection is present) and 7,413 screening cases (in which the fungus is detected but not causing infection) reported through December 31, 2021. Clinical cases have increased each year since 2016, with the most rapid rise occurring during 2020-2021. CDC has continued to see an increase in case counts for 2022. During 2019-2021, 17 states identified their first C. auris case ever. Nationwide, clinical cases rose from 476 in 2019 to 1,471 in 2021. Screening cases tripled from 2020 to 2021, for a total of 4,041. Screening is important to prevent spread by identifying patients carrying the fungus so that infection prevention controls can be used.
The CDC's Antimicrobial Resistance Laboratory Network, which provides nationwide lab capacity to rapidly detect antimicrobial resistance and inform local responses to prevent spread and protect people, provided some of the data for this report. CDC worked to significantly strengthen laboratory capacity, including in state, territorial, and local health departments, through supplemental funding supported by the American Rescue Plan Act. These efforts include increasing susceptibility testing capacity for C. auris from seven Regional Labs to more than 26 labs nationwide.
CDC continues to work with state, local, and territorial health departments and other partners to address this emerging threat to public health. Review more information on C. auris, the Antimicrobial Resistance Threats Report that identified C. auris as an urgent threat in the United States, or the WHO fungal priority pathogen list that identifies C. auris as a priority globally.
Copyright © CDC. All rights reserved.
Source: Increasing Threat of Spread of Antimicrobial-resistant Fungus in Healthcare Facilities. Centers for Disease Control and Prevention. 2023; 320. Published: March 20, 2023. https://www.cdc.gov/media/releases/2023/p0320-cauris.html.
Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 5 Years of Follow-up
Trabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy.
KEY FINDINGS: Trabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy. No significant difference in the rate of surgical failure was observed between the 2 surgical procedures at 5 years.
BACKGROUND: Aim of this study is to report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.
DETAILS: Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 2 minutes). The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP <= 5 mmHg, reoperation for glaucoma, or loss of light perception. Secondary outcome measures included IOP, glaucoma medical therapy, and visual acuity. The cumulative probability of failure after 5 years of follow-up was 42% in the tube group and 35% in the trabeculectomy group (P = 0.21; hazard ratio = 1.31; 95% confidence interval = 0.86-2.01). At 5 years, IOP (mean ± standard deviation) was 13.4 ± 3.5 mmHg in the tube group and 13.0 ± 5.2 mmHg in the trabeculectomy group (P = 0.52), and the number of glaucoma medications (mean ± standard deviation) was 2.2 ± 1.3 in the tube group and 1.3 ± 1.4 in the trabeculectomy group (P < 0.001).
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Source: Gedde, S. J. Feuer, W. J., Lim, K. S. (2023). Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 5 Years of Follow-up. Ophthalmology. 2023; 129(12): 1344-1356. Published: February, 2023. DOI: 10.1016/j.ophtha.2022.07.003.
Dropless Penetrating Keratoplasty Using A Subconjunctival Dexamethasone Implant
This study is the first proof of concept that dropless immunosuppression is possible after low rejection risk PK.
KEY FINDINGS: This study is the first proof of concept that dropless immunosuppression is possible after low rejection risk PK.
BACKGROUND: Rejection is the main cause of graft failure after penetrating keratoplasty (PK). Its prevention by repeated instillation of steroid eye-drops has not evolved in decades. Poor adherence and discontinuous nature of eye-drop treatment may explain some PK failures. In a rabbit model, we previously demonstrated that a subconjunctival dexamethasone implant was well tolerated and prevented rejection efficiently in the first 5–6 weeks. This clinical trial investigates its tolerance and safety after PK.
DETAILS: Designed to analyse the risk of elevated intraocular pressure (IOP), discomfort and resorption time. Fourteen patients with a low rejection risk indication of PK were enrolled between January 2017 and August 2018. The implant was injected in the 12 o'clock position, 5 mm from the limbus, at the end of PK. A steroid eye-drop treatment was planned when implant resorption was complete. Patients were monitored regularly for 12 months: IOP (main outcome measure at 1 month), discomfort and redness scores, implant status, rejection episode and central corneal thickness by optical coherence tomography. An independent data safety monitoring committee verified safety aspects. No increase in IOP or other adverse event related to the implant was observed. Average resorption time was 6 weeks. The switch to steroid eye-drops was uneventful. One patient, included despite preoperative corneal neovascularisation (unintended protocol deviation) experienced a rejection.
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Copyright © BMJ Publishing Group Ltd. All rights reserved.
Source: Trone, M. C., Poinard, S., Crouzet, E., et al. (2023). Dropless Penetrating Keratoplasty Using A Subconjunctival Dexamethasone Implant: Safety Pilot Study. British Journal of Ophthalmology. 2023; 107(2): 181-186. Published: February, 2023. DOI: 10.1136/bjophthalmol-2021-319376.
Multipressure Dial Goggle Effects on Circumpapillary Structure and Microvasculature in Glaucoma Patients
Circumpapillary CD measurements showed a dose-dependent increase with the induction of negative pressure, while RNFL thickness measurements remained unchanged.
KEY FINDINGS: Circumpapillary CD measurements showed a dose-dependent increase with the induction of negative pressure, while RNFL thickness measurements remained unchanged.
BACKGROUND: Objective of this study is to evaluate the effects of pressure changes induced by a multipressure dial (MPD) on circumpapillary retinal nerve fiber layer (RNFL) and capillary density (CD) measurements in patients with glaucoma using OCT angiography (OCTA).
DETAILS: One eye of each patient underwent negative pressure application with the MPD. The MPD alters intraocular pressure (IOP) relative to atmospheric pressure by generating a negative pressure vacuum within a goggle chamber that is placed over the eye. Each participant underwent serial high density OCTA imaging (AngioVue) of the optic nerve head at different negative pressure increments of -5 mmHg, starting from 0 mmHg, ending at -20 mmHg, and then returning to baseline. Images were acquired after 2 minutes of sustained negative pressure at each target pressure to allow for stabilization of the retinal structures and microvasculature. The RNFL thickness and CD measurements were automatically calculated using the native AngioVue software, and then exported for analysis. The mean (± SD) age was 71.0 years (± 7.8 years), the baseline IOP was 17.5 mmHg (± 3.6 mmHg), and there was a mean 24-2 mean deviation of -2.80 dB (± 2.55 dB). Serial circumpapillary CD measurements showed a statistically significant dose-dependent increase from baseline, without negative pressure application, to the maximum negative pressure application of -20 mmHg (difference, 2.27%; P = 0.010). Capillary density measurements then decreased symmetrically when lowering the negative pressure to baseline. Circumpapillary CD measurements at target negative pressures of -10 mmHg, -15 mmHg, and -20 mmHg were significantly higher than the baseline measurements (all P values 0.05). Circumpapillary RNFL thickness remained the same throughout different levels of negative pressure.
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Source: Kamalipour, A., Mogimi, S., Inpirom, V. R., et al. (2022). Multipressure Dial Goggle Effects on Circumpapillary Structure and Microvasculature in Glaucoma Patients. Ophthalmology Glaucoma. 2022; 5(6): 572-580. Published: November-December, 2022. DOI: 10.1016/j.ogla.2022.05.004.
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