[Posted 12/Sep/2023]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: Experience of introducing PreserFlo MicroShunt surgery showed it was safer than trabeculectomy and is a cost-saving and effective option that offers potential to free up highly limited National Health Service resources.

BACKGROUND: Objective of this study was to conduct clinical evaluation and cost analysis of mitomycin-C–augmented PreserFlo MicroShunt versus trabeculectomy. This retrospective cohort study was done across 3 teaching hospitals with total of 134 consecutive eyes of 129 patients (70 undergoing MicroShunt, 64 trabeculectomy).

DETAILS: Primary and secondary glaucoma cases with uncontrolled intraocular pressure (IOP) were included. Neovascular glaucoma and surgery combined with cataract extraction were excluded. The cost analysis used results from the clinical study to estimate operative costs (equipment and staff costs) and postoperative costs (follow-up visits, nonglaucoma medications, and postoperative procedures) per eye for PreserFlo and trabeculectomy. The primary clinical outcome measure was surgical failure (defined as IOP > 21 mmHg or < 20% reduction from baseline, IOP <= 5 mmHg, reoperation, or loss of light perception) or qualified and complete success (with or without medication) at 18 months. Secondary measures were IOP, glaucoma medications, visual acuity, mean deviation, time to cessation of steroid drops, complications, surgical time, follow-up visits, postoperative interventions, and reoperations. The cost analysis evaluated costs of PreserFlo compared with trabeculectomy. Baseline characteristics were similar, except for more non-White patients in the trabeculectomy group (51% Black and Asian vs. 32% MicroShunt, P = 0.02) and more cases with prior ab externo glaucoma surgery in the MicroShunt group (19% vs. 3% in the trabeculectomy group, P = 0.004). Overall, 59% of eyes had primary open-angle glaucoma. Mean follow-up was 19.9 months for both groups. At 18 months, surgical failure was 25% for MicroShunt compared with 35% for trabeculectomy (P = 0.18). Failure in MicroShunt cases was due to inadequate IOP reduction (84%) or reoperation for glaucoma (16%). Failure in trabeculectomy cases was due to inadequate IOP reduction (58%), persistent hypotony (29%), or reoperation for glaucoma (13%). Combined blebitis and endophthalmitis rate was 1.4% for MicroShunt and 3.1% for trabeculectomy. Cost analysis showed a savings of £245 to £566 per eye in the MicroShunt group, driven mostly by reduced postoperative procedures and follow-up visits. This is in contrast to prior randomized controlled trial data reporting the incremental cost of $2058 of PreserFlo over trabeculectomy.

Copyright © The American Academy of Ophthalmology. All rights reserved.

Source: Van Lancker, L., Saravanan, A., Abu-Bakra, M., et al. (2023). Clinical Outcomes and Cost Analysis of PreserFlo versus Trabeculectomy for Glaucoma Management in the United Kingdom. Ophthalmology Glaucoma. 2023; 6(4): 342-357. Published: September, 2023. DOI: 10.1016/j.ogla.2022.11.006.

A Novel Technique

[Posted 17/Jul/2023]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: Sutureless CSM is a promising alternative to traditional MMCR and sutured CSM based on long-term outcomes, symmetry, shorter operative time, and low complication rate.

BACKGROUND: Müller muscle-conjunctival resection (MMCR) is a popular posterior/internal surgical approach to cases of mild to moderate blepharoptosis with good levator function. MMCR necessitates the removal of healthy conjunctiva and exposes the cornea to suture material. The goal of this study is to describe a novel sutureless conjunctiva-sparing Müllerectomy (CSM) surgery and demonstrate its long-term efficacy, efficiency, and safety.

DETAILS: IRB approved retrospective study of patients undergoing sutureless conjunctiva-sparing posterior ptosis repair surgery. The medical records of 100 patients (171 eyes) who underwent sutureless CSM with a minimum follow-up interval of 6 months were retrospectively reviewed. Photographs were analyzed using ImageJ software. Outcome measures were derived from margin reflex distance 1 (MRD1) and palpebral fissure height (PFH) at various postoperative timepoints. Mean ΔMRD1 and ΔPFH at 6 months were 2.85 ± 0.98 mm and 2.60 ± 1.38 mm, respectively. Symmetry within 1 mm was observed 91% of cases. Sutureless CSM took 4.42 minutes on average compared to 8.45 minutes for traditional MMCR. There were no corneal abrasions or ocular complications. The reoperation rate was 2.3% (1 case of overcorrection and 3 cases of undercorrection) per eye.

Copyright © Elsevier Inc. All rights reserved.

Source: Mancini, R., Forouzan, P., Keenum, Z. G., et al. (2023). Sutureless Conjunctiva-Sparing Posterior Ptosis Repair Surgery: A Novel Technique. American Journal of Ophthalmology. 2023; 251: 77-89. Published: July, 2023. DOI: 10.1016/j.ajo.2023.03.001.

[Posted 18/May/2023]

AUDIENCE: Ophthalmology, Internal Medicine

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.

Copyright © The American Academy of Ophthalmology. All rights reserved.

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.

[Posted 10/Apr/2023]

AUDIENCE: Endocrinology, Ophthalmology

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%).

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.

[Posted 24/Mar/2023]

AUDIENCE: Infectious Disease, Internal Medicine

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.

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.

[Posted 1/Mar/2023]

AUDIENCE: Ophthalmology, Internal Medicine

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).

Copyright © American Academy of Ophthalmology. All rights reserved.

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.