Prevalence and Correlation to Visual Field Loss

[Posted 20/Jul/2022]

AUDIENCE: Ophthalmology, Family Medicine

KEY FINDINGS: Charles Bonnet Syndrome was not a rare condition in patients with glaucoma. Patients with a combination of advanced VFL and low BCVA had the highest risk of CBS; however, 1 of 3 patients with CBS had a BCVA of >=0.5 in both eyes. These findings emphasize the importance of being attentive to symptoms of CBS in patients with glaucomatous VFL even when visual acuity is preserved.

BACKGROUND: Objective of this study is to determine the prevalence and characteristics of Charles Bonnet Syndrome (CBS) and its relation to visual field loss (VFL) in patients with open-angle glaucoma (OAG).

DETAILS: Patients attending the glaucoma outpatient department of the Skane University hospital, Malmo, Sweden, between April 1, 2018, and December 31, 2018, were consecutively evaluated for inclusion. Potentially eligible patients admitting to having complex visual hallucinations were interviewed to explore the characteristics of their hallucinatory experiences. Recent automated visual field examinations were available for all participants, and swept-source OCT was performed in participants with CBS to rule out previously undiagnosed macular pathology. The correlation between potential risk factors and CBS was evaluated with logistic regression analysis. Charles Bonnet Syndrome was not a rare condition in patients with glaucoma. Patients with a combination of advanced VFL and low BCVA had the highest risk of CBS; however, 1 of 3 patients with CBS had a BCVA of >=0.5 in both eyes. These findings emphasize the importance of being attentive to symptoms of CBS in patients with glaucomatous VFL even when visual acuity is preserved.

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

Source: Peters, D., Molander, S., Lomo, T., et al. (2022). Charles Bonnet Syndrome in Patients with Open-Angle Glaucoma: Prevalence and Correlation to Visual Field Loss. Ophthalmology Glaucoma. 2022; 5(3): 337-344. Published: May 1, 2022. DOI: Charles Bonnet Syndrome in Patients with Open-Angle Glaucoma.

[Posted 18/Jan/2024]

AUDIENCE: Endocrinology, Ophthalmology

KEY FINDINGS: Teprotumumab significantly improved proptosis vs placebo in longstanding/low inflammation TED, demonstrating efficacy regardless of disease duration/activity. The safety profile was comparable to that previously reported.

BACKGROUND: Early inflammatory thyroid eye disease (TED) can lead to symptomatic chronic disease, including disabling proptosis. Teprotumumab, an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, previously demonstrated efficacy in acute, high-inflammation TED trials. Objective of the study was to present data from the first placebo-controlled trial with teprotumumab in chronic/low disease activity TED.

DETAILS: This randomized double-masked, placebo-controlled trial, conducted at 11 US centers, enrolled adult participants with TED duration of 2 to 10 years, Clinical Activity Score (CAS) <= 1 or no additional inflammation or progression in proptosis/diplopia for >=1 year, proptosis >=3 mm from before TED and/or from normal, euthyroid/mildly hypo/hyperthyroid, no prior teprotumumab, and no steroids within 3 weeks of baseline. Patients received (2:1) intravenous teprotumumab or placebo once every 3 weeks (total 8 infusions). The primary endpoint was proptosis (mm) improvement at Week 24. Adverse events (AEs) were assessed. A total of 62 (42 teprotumumab and 20 placebo) patients were randomized. At Week 24, least squares mean (SE) proptosis improvement was greater with teprotumumab (-2.41 [0.228]) than with placebo (-0.92 [0.323]), difference -1.48 (95% CI -2.28, -0.69; P = .0004). Proportions of patients with AEs were similar between groups. Hyperglycemia was reported in 6 (15%) vs 2 (10%) and hearing impairment in 9 (22%) vs 2 (10%) with teprotumumab and placebo, respectively. AEs led to discontinuation in 1 teprotumumab (left ear conductive hearing loss with congenital anomaly) and 1 placebo patient (infusion-related). There were no deaths.

Copyright © The Author(s). Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved.

Source: Douglas, R. S., Couch, S., Wester, S. T., et al. (2024). Efficacy and Safety of Teprotumumab in Patients With Thyroid Eye Disease of Long Duration and Low Disease Activity. The Journal of Clinical Endocrinology & Metabolism. 2024; 109(1): 25-35. Published: January, 2024. DOI: 10.1210/clinem/dgad637.

[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.