[Posted 7/Jun/2022]

AUDIENCE: Ophthalmology, Family Medicine

KEY FINDINGS: Dynamic blood flow metrics measured with the XyCAM RI are reliable, are associated with structural and functional glaucoma metrics, and are significantly different among glaucoma, glaucoma suspect, and control participants. The XyCAM RI may serve as an important tool in glaucoma management in the future.

BACKGROUND: Objective of the study is to assess the repeatability of blood flow velocity index (BFVi) metrics obtained with a recently Food and Drug Administration–cleared laser speckle contrast imaging device, the XyCAM RI (Vasoptic Medical, Inc), and to characterize differences in these metrics among control, glaucoma suspect, and glaucoma participants.

DETAILS: Key dynamic BFVi metrics—mean, peak, dip, volumetric rise index (VRI), volumetric fall index (VFI), time to rise (TtR), time to fall (TtF), blow-out time (BOT), skew, and acceleration time index—were measured in the optic disc, optic disc vessels, optic disc perfusion region, and macula in 4 imaging sessions on the same day. Intrasession and intersession variability were calculated using the coefficient of variation (CV) for each metric in each region of interest (ROI). Values for each dynamic BFVi variable were compared between glaucoma, glaucoma suspect, and control participants using bivariate and multivariate analysis. Pearson correlation coefficients were used to correlate each variable in each ROI with age, intraocular pressure, cup-to-disc ratio (CDR), mean deviation, pattern standard deviation, retinal nerve fiber layer thickness, and minimum rim width. Intersession CV for mean, peak, dip, VRI, VFI, TtR, and TtF ranged from 3.2 ± 2.5% to 11.0 ± 3.8%. Age, CDR, OCT metrics, and visual field metrics showed significant correlations with dynamic BFVi variables. Peak, mean, dip, VRI, and VFI were significantly lower in patients with glaucoma than in control participants in all ROIs except the fovea. These metrics also were significantly lower in glaucoma patients than glaucoma suspect patients in the disc vessels.

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

Source: Vinnett, A., Kandukuri, J., Le, C., et al. (2022). Dynamic Alterations in Blood Flow in Glaucoma Measured with Laser Speckle Contrast Imaging. Ophthalmology Glaucoma. 2022; 5(3): 250-261. Published: May 1, 2022. DOI: 10.1016/j.ogla.2021.10.005.

[Posted 11/May/2022]

AUDIENCE: Ophthalmology

KEY FINDINGS: Whereas the rate of GCC thinning was faster on average in suspect eyes than in healthy eyes, some suspect eyes showed significant loss of vessel density and faster vessel density loss than GCC thinning. OCT and OCTA are complementary and useful for evaluating eyes with OHT or GON.

BACKGROUND: Objective of this study is to characterize the change of ganglion cell complex (GCC) thickness and macular vessel density in glaucoma suspect eyes with ocular hypertension (OHT) or glaucomatous optic neuropathy (GON).

DETAILS: OCT angiography (OCTA)-based vessel density and OCT-based structural thickness of the 3 x 3-mm¹ GCC scan slab were evaluated at each visit. The rates of vessel density and thickness change were compared across diagnostic groups using a linear mixed-effects model. Significant mean rates of both GCC thinning and vessel density loss were detectable in OHT and GON groups. Of the individual suspect eyes, 49.1% showed significant loss (P < 0.05) with either vessel density or GCC thickness. Of the GON eyes, 31.0% showed both significant GCC loss and vessel density loss, 51.7% showed only significant GCC loss, whereas 17.2% showed only significant vessel density loss. Vessel density loss was faster than GCC thinning in half of the suspect eyes based on percent loss analysis. The age and scan quality-adjusted GCC thinning rates of the OHT group (-0.59 µm/year; P = 0.025) and GON group (-0.79 µm/year; P = 0.058) were faster than those of the healthy group (-0.11 µm/year), whereas the rate of vessel density loss was not significantly different among the diagnostic groups (all P > 0.2). Higher mean intraocular pressure during follow-up was associated with faster GCC thinning in the OHT group (P = 0.065) and GON groups (P = 0.015), but was not associated with the rate of vessel density decrease.

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

Source: Hou, H., Moghimi, S., Kamalipour, A., et al. (2022). Macular Thickness and Microvasculature Loss in Glaucoma Suspect Eyes. Ophthalmology Glaucoma. 2022; 5(2): 170-178. Published: April, 2022. DOI: 10.1016/j.ogla.2021.07.009.

The Prevalence of Autoimmune Diseases in Patients with Primary Open-Angle Glaucoma Undergoing Ophthalmic Surgeries

[Posted 5/Apr/2022]

AUDIENCE: Ophthalmology, Family Medicine

KEY FINDINGS: A higher prevalence of AiD was found in POAG patients compared with control patients undergoing ophthalmic surgery. The presence of AiD was associated with increased risk for POAG after adjusting for covariates. Additional factors may have prevented a difference in RNFL thickness in POAG patients with and without AiD. Autoimmunity should be explored further in the pathogenesis of POAG.

BACKGROUND: Objective of this study was to assess the prevalence of autoimmune disease (AiD) in patients with primary open-angle glaucoma (POAG) undergoing ophthalmic surgery. Participants were the patients with POAG undergoing any ophthalmic surgery and control subjects undergoing cataract surgery at the Massachusetts Eye and Ear from March 2019 to April 2020.

DETAILS: All available medical records with patient demographics, ocular, and medical conditions were reviewed. Differences in AiD prevalence were assessed and adjusted for covariates using multiple logistic regression. Additionally, a subgroup analysis comparing the POAG patients with and without AiD was performed. A total of 172 patients with POAG and 179 controls were included. The overall prevalence of AiD was 17.4% in the POAG group and 10.1% in the controls (P = 0.044); 6.4% of POAG patients and 3.4% of controls had more than 1 AiD (P = 0.18). The most prevalent AiDs in POAG group were rheumatoid arthritis (4.6%) and psoriasis (4.1%), which were also the most common in controls (2.8% each). In a fully adjusted multiple logistic regression analysis accounting for steroid use, having an AiD was associated with 2.62-fold increased odds of POAG relative to controls (95% confidence interval, 1.27-5.36, P = 0.009); other risk factors for POAG derived from the analysis included age (odds ratio [OR], 1.04, P = 0.006), diabetes mellitus (OR, 2.31, P = 0.008), and non-White ethnicity (OR, 4.75, P < 0.001). In a case-only analysis involving the eye with worse glaucoma, there was no statistical difference in visual field mean deviation or retinal nerve fiber layer (RNFL) thickness in POAG patients with AiD (n = 30) and without AiD (n = 142, P > 0.13, for both).

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

Source: Lorenzo, M. M., Devlin, J., Saini, C., et al. (2022). The Prevalence of Autoimmune Diseases in Patients with Primary Open-Angle Glaucoma Undergoing Ophthalmic Surgeries. Ophthalmology Glaucoma. 2022; 5(2): 128-136. Published: March/April, 2022. DOI: 10.1016/j.ogla.2021.08.003.

Class I Recall - Because They Are Not Authorized, Cleared, or Approved by the FDA

[Posted 15/Mar/2022]

AUDIENCE: All Healthcare Professionals

ISSUE: LuSys Laboratories is recalling these tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the United States. In addition, LuSys Laboratories did not provide appropriate validation data to show that the tests can perform accurately. This means there is a risk of potential false negative, false positive, and misinterpretation of results from these tests. LuSys Laboratories has received no complaints or reports of injuries, deaths, or adverse events.

BACKGROUND:

• The LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to detect proteins, called antigens, on the SARS-CoV-2 virus.
• The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples to look for antibodies produced by a person's immune system in response to SARS-CoV-2, the virus that causes COVID-19, suggesting a recent or previous infection.

RECOMMENDATIONS: On January 13, 2022, and January 24, 2022, LuSys Laboratories sent Urgent Medical Device Recall letters to device customers, distributors, and other U.S. consignees requesting them to take the following actions:

• Immediately stop using these tests.
• If the tests were distributed to third parties, immediately provide all consignees with a copy of this recall notification.
• Discard, destroy, or return all COVID-19 tests manufactured or distributed by LuSys Laboratories, Inc., a.k.a. Luscient Diagnostics LLC.

Source: FDA Recall - COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests by LuSys Laboratories. Published: March 14, 2022.

Burden of Trabeculectomy and Glaucoma Drainage Implantation after Laser Trabeculoplasty

A Two-Year Follow-up Study

[Posted 2/Mar/2022]

AUDIENCE: Ophthalmology

KEY FINDINGS: Laser trabeculoplasty did not alter the need for subsequent incisional glaucoma surgery among glaucoma suspects or patients with mild OAG. Regardless of treatment with LTP, African heritage and OAG diagnosis status were risk factors for requiring glaucoma surgery.

BACKGROUND: Aim of the study was to evaluate the burden of incisional glaucoma surgery (trabeculectomy and glaucoma drainage device implantation) after laser trabeculoplasty (LTP) in the United States.

DETAILS: Subjects aged 35 years or older at the time of LTP with ocular hypertension, suspected glaucoma, or mild open-angle glaucoma (OAG) were matched to a comparison group without LTP on the basis of age, gender, race, geographic region, and glaucoma diagnosis codes. Survival analysis and Cox proportional hazard analysis were performed. Primary analysis included risk of incisional glaucoma surgery. Secondary analysis included risk of conversion to moderate or severe OAG based on billing data. The mean age of study participants was 75.0 ± 8.9 years. After 2 years, 40 of 2435 eyes required incisional glaucoma surgery after LTP, and 51 of 2435 eyes required glaucoma surgery in the comparison group (P = 0.27, adjusted for covariates). Regardless of intervention, Black Americans were more likely to require glaucoma surgery (hazard ratio [HR], 1.89; 95% confidence interval [CI], 1.13-3.17). Patients with a diagnosis of OAG were more likely to require surgery than glaucoma suspects (HR, 2.03; 95% CI, 1.12-3.69). Black Americans were also more likely to require surgery or convert to more severe glaucoma (HR, 3.21; 95% CI, 1.92-5.37) versus White Americans.

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

Source: Lee, R. H., Lee, R. K., Pasquale, L. R., et al. (2022). Burden of Trabeculectomy and Glaucoma Drainage Implantation after Laser Trabeculoplasty: A Two-Year Follow-up Study. Ophthalmology Glaucoma. 2022; 5(1): 58-66. Published: January 1, 2022. DOI: 10.1016/j.ogla.2021.07.004.