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.
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.
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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.
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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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.
Clinicians' Use of Quantitative Information while Assessing the Rate of Functional Progression in Glaucoma
Adherence to frequent postoperative eye drops was high and can be successfully monitored remotely. Surgical success was greater among eyes with nearly ideal adherence and was poorer in older persons and those with more advanced glaucoma.
KEY FINDINGS: Expert academic glaucoma specialists' assessment of the rate of change correlated best with VFI rates, except in eyes with a VFI near the ceiling of 100%. Sensitivities averaged within clusters of locations have been shown to detect change sooner, but the experts' opinions correlated more closely with global VFI. This could be because it is currently the only index for which the perimeter automatically provides a quantitative estimate of the rate of functional progression.
BACKGROUND: Clinicians use both global and point-wise information from visual fields to assess the rate of glaucomatous functional progression. We asked which objective, quantitative measures best correlated with subjective assessment by glaucoma experts. In particular, we aimed to determine how much that judgment was based on localized rates of change vs. on global indices reported by the perimeter.
DETAILS: Eleven academic, expert glaucoma specialists independently scored the rate of functional progression, from 1 (improvement) to 7 (very rapid progression), for a series of 5 biannual clinical printouts from 100 glaucoma or glaucoma suspect eyes of 51 participants, 20 of which were scored twice to assess repeatability. Regression models were used to predict the average of the 11 clinicians' scores based on objective rates of change of mean deviation (MD), visual field index (VFI), pattern standard deviation (PSD), the Nth fastest progressing location, and the Nth fastest progressing of 10 anatomically defined clusters of locations after weighting by eccentricity. The average MD of the study eyes was -2.4 dB (range, -16.8 to +2.8 dB). The mean clinician score was highly repeatable, with an intraclass correlation coefficient of 0.95. It correlated better with the rate of change of VFI (pseudo-R2 = 0.73, 95% confidence interval [CI, 0.60-0.83]) than with MD (pseudo-R2 = 0.63, 95% CI [0.45-0.76]) or PSD (pseudo-R2 = 0.41, 95% CI [0.26-0.55]). Using point-wise information, the highest correlations were found with the fifth-fastest progressing location (pseudo-R2 = 0.71, 95% CI [0.56-0.80]) and the fastest-progressing cluster after eccentricity weighting (pseudo-R2 = 0.61, 95% CI [0.48-0.72]). Among 25 eyes with an average VFI of > 99%, the highest observed pseudo-R2 value was 0.34 (95% CI [0.16-0.61]) for PSD.
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Source: Gardiner, S. K., Kinast, R. M., De Morases, C., et al. (2022). Clinicians' Use of Quantitative Information while Assessing the Rate of Functional Progression in Glaucoma. Ophthalmology Glaucoma. 2022; 5(5): 498-506. Published: September 1, 2022. DOI: 10.1016/j.ogla.2022.03.002.
Electronically Monitored Corticosteroid Eye Drop Adherence after Trabeculectomy Compared to Surgical Success
Adherence to frequent postoperative eye drops was high and can be successfully monitored remotely. Surgical success was greater among eyes with nearly ideal adherence and was poorer in older persons and those with more advanced glaucoma.
KEY FINDINGS: Adherence to frequent postoperative eye drops was high and can be successfully monitored remotely. Surgical success was greater among eyes with nearly ideal adherence and was poorer in older persons and those with more advanced glaucoma.
BACKGROUND: Objective of this study was to compare electronically measured adherence with topical corticosteroid (CS) drops with outcomes of glaucoma surgery. This prospective cohort study included eyes undergoing surgery from August 2019 to January 2021 and followed for up to 1 year.
DETAILS: All patients were recruited from the Glaucoma Center of Excellence at the Wilmer Eye Institute, Johns Hopkins. Eligible patients had primary open-angle or angle-closure glaucoma, were aged >=18 years, and underwent trabeculectomy (with or without cataract surgery) or tube-shunt implantation. All patients were recruited from the Glaucoma Center of Excellence at the Wilmer Eye Institute, Johns Hopkins. Eligible patients had primary open-angle or angle-closure glaucoma, were aged >=18 years, and underwent trabeculectomy (with or without cataract surgery) or tube-shunt implantation. Among 90 patients, adherence was 89.7% ± 13.7% overall and 80.9% ± 15.8% during dosing every 2 hours. Target IOP was achieved at the final visit (6 months or 1 year) in 81% (59/73) without reoperation. Eyes with a higher ratio of drops taken versus prescribed were significantly more likely to achieve target IOP at 6 months/1 year (P = 0.05). Total adherence was better in younger persons, eyes with less field loss, and patients of one particular surgeon (P < 0.03). Percent adherence during dosing every 2 hours was higher in eyes with higher target IOP (P = 0.01). No adherence outcome was significantly related to race, sex, bleb morphology, postoperative pain, or postoperative anterior chamber inflammation. Adherence values did not significantly correlate with adherence questionnaire data (predicted mean = 78% ± 17%, actual mean = 91% ± 13% adherent, P < 0.001).
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Source: McGlumphy, E. J., Doto, N. O., Johnson, T. V., et al. (2022). Electronically Monitored Corticosteroid Eye Drop Adherence after Trabeculectomy Compared to Surgical Success. Ophthalmology Glaucoma. 2022; 5(4): 379-387. Published: July 1, 2022. DOI: 10.1016/j.ogla.2021.12.007.
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