Review of Ophthalmology Online



Vol. 20, #41   •   Monday, September 28, 2020


In this Issue:


Microvascular Impairments in Diabetic Patients Without Retinopathy

Researchers evaluated microvascular impairments with optical coherence tomography angiography in the eyes of diabetic patients with no diabetic retinopathy, as part of a systematic review and meta-analysis.

They searched PubMed and Embase databases to identify studies using OCTA to compare microvascular changes between diabetic eyes without clinical retinopathy and healthy controls. They extracted and analyzed data of interest using Review Manager V.5.3 and Stata V.14.0. They used weighted mean differences and their 95% confidence intervals to assess the strength of the association.

Forty-four cross-sectional studies involving 2,221 diabetic and 1,838 healthy eyes were included. Here were some of the findings:
• OCTA revealed that, compared with the healthy control group, the NDR group manifested enlarged areas and increased perimeters of the foveal avascular zone, with decreased perfusion density in the superficial and deep capillary plexus of the macula (except parafoveal PD of the inner retina and foveal PD) and reduced radial peripapillary capillary PD.
• In addition, subgroup analyses according to the type of diabetes mellitus indicated that most of those differences became nonsignificant (except parafoveal PD in the deep capillary plexus) in type 1 diabetes mellitus, while in type 2 diabetes mellitus, they remained statistically significant.

The researchers wrote that their findings suggested that retinal microvascular impairments might have occurred prior to clinically visible diabetic retinopathy and could be detected early by OCTA. However, they added, those manifestations could be inconsistent according to the types of diabetes mellitus.

SOURCE: Zhang B, Chou Y, Zhao X, et al. Early detection of microvascular impairments with optical coherence tomography angiography in diabetic patients without clinical retinopathy: A meta-analysis. Am J Ophthalmol 2020; Sept 31. [Epub ahead of print].


Complimentary CME Education Videos


10-2 VF Testing in Glaucoma Patients with Early 24-2 VF Loss

Investigators sought to determine whether the 10-2 test of the Humphrey Field Analyzer detected a higher proportion of abnormal visual fields compared with the 24-2 test in the central 10 degrees in individuals with early VF damage, as part of a prospective, observational study. One of the study’s authors received funding from the Alcon Research Institute, and is also a consultant for CenterVue, Heidelberg Engineering and Topcon.

Participants included individuals with early open-angle glaucoma and healthy controls. All subjects underwent a 24-2 and 10-2 test. Only the 12 central test locations of the 24-2 test were included to analyze equivalent VF areas. Investigators compared the performance of the two tests across four pointwise criteria: total deviation (TD) and pattern deviation (PD) analyses at the 5-percent and 2-percent levels. They also conducted analyses for two pairs of follow-up tests, each performed four months apart.

Main outcome measures included:
• area under the receiver operating characteristics curve (AUC);
• sensitivity at identically matched specificity for the four criteria;
• overlap (whole field and by quadrant) of abnormal VFs with both tests; and
• repeatability of the findings over two follow-up tests.

One eye each of 97 individuals with early glaucoma (median mean deviation, -2.31 dB) and 65 controls were included. Here were some of the findings:
• The AUCs for the 24-2 and 10-2 weren’t significantly different for any of the four criteria and ranged from 0.88 to 0.93 (24-2); and 0.91 to 0.94 (10-2).
• At matched specificity, the sensitivity of the 24-2 was significantly higher for all criteria except for PD analysis at 5 percent.
• In individuals with an abnormal field with either test, the overlap varied from 60 to 86 percent depending on the criterion, while analysis according to quadrant yielded a concordance ranging from 70 percent to 87 percent.
• Over the follow-up, the repeatability of the test result (both 24-2 and 10-2 testing as abnormal; either abnormal; or both normal) was achieved in 55 to 70 percent of patients.

In this study of glaucoma patients with early damage with the 24-2 test, investigators found little evidence that adding the 10-2 test revealed additional undetected defects in the central VF. They suggested it might be more prudent to reserve 10-2 testing for following selected patients with a higher risk of progression in the central VF.

SOURCE: West ME, Sharpe GP, Hutchison DM, et al. Utility of 10-2 visual field testing in glaucoma patients with early 24-2 visual field loss. Ophthalmology 2020; Sep 5. [Epub ahead of print].


Complimentary CME Education Videos


Automated DR Detection with Two Retinal Imaging Devices Using AI

Scientists evaluated the diagnostic performance of an automated artificial intelligence-based diabetic retinopathy algorithm with two retinal imaging systems using two different technologies: a conventional flash fundus camera (TRC-NW8, Topcon) and a white LED confocal scanner (Eidon, Centervue). Two of the authors are consultants for Centervue.

On the same day, individuals underwent dilated color fundus photography using a conventional flash fundus camera and a fully automated white LED confocal scanner. All images were analyzed for DR severity both by retina specialists and the AI software EyeArt (Eyenuk), and graded as referable DR (RDR) or not RDR. Sensitivity, specificity and the area under the curve (AUC) were computed.

A series of 165 diabetic subjects (330 eyes) were enrolled. The automated algorithm achieved 90.8-percent sensitivity with 75.3-percent specificity on images acquired with the conventional fundus camera, and 94.1-percent sensitivity with 86.8-percent specificity on images obtained from the white LED confocal scanner. The difference between AUC was 0.0737 (p=0.0023).

Investigators concluded that the automated image analysis software was well-suited to work with different imaging technologies. They suggested that further evaluation in the context of screening campaigns would be needed.

SOURCE: Sarao V, Veritti D, Lanzetta P. Automated diabetic retinopathy detection with two different retinal imaging devices using artificial intelligence: A comparison study. Graefes Arch Clin Exp Ophthalmol 2020; Sep 16. [Epub ahead of print].


Topography-guided vs. Standard CXL to Treat Progressive Keratoconus

Researchers compared the safety and efficacy of topography-guided customized corneal cross-linking (PiXL) with standard cross-linking (CXL) for the treatment of progressive keratoconus.

In a prospective, interventional analysis, the eyes of individuals with progressive keratoconus underwent standard cross-linking (homogenous 9-mm ultraviolet-A irradiation of 9 mW/cm2 delivering a total fluence of 5.4J/cm2) vs. topography-guided customized cross-linking (30 mW/cm2 pulsed irradiance with a total fluence ranging from 5.4 to 15 J/cm2, in concentric circles centered on the posterior float maximum). Researchers analyzed the following parameters at the preoperative, one- and six-month, and one-year postoperative visits:
• corrected spectacle distance visual acuity;
• manifest refraction, including sphere;
• cylinder and mean refractive spherical equivalent;
• corneal tomography;
• higher order aberration profile; and
• endothelial cell count.
Researchers performed an anterior-segment optical coherence tomography evaluation at the one-month postoperative visit to assess the depth of the demarcation line.

Sixty-four eyes of 45 individuals (32 eyes in each group) were included. Here were some of the findings:
• A significant reduction was found in maximum keratometry and IS asymmetry in the PiXL group at the six-month visit (p=0.001) and one-year postoperative visit (p=0.06).
• Corrected spectacle distance visual acuity improved significantly in the PiXL group (0.05 ±0.08 logMAR, p=0.02) vs. the standard CXL group (0.01 ±0.025 logMAR, p=0.26).
• A greater depth of a stromal demarcation line was observed in the customized CXL group (p=0.02).
• No significant complications were noted in either cohort.

Researchers determined that PiXL demonstrated similar safety, with significantly greater keratometry flattening and corneal regularization, relative to standard CXL. They added that this resulted in significant improvement of spectacle-corrected visual acuity for eyes with mild-to-moderate keratoconus.

SOURCE: Sachdev GS, Ramamurthy S, B S, et al. Comparative analysis of safety and efficacy of topography-guided customized cross-linking and standard cross-linking in the treatment of progressive keratoconus. Cornea 2020; Sep.16, [Epub ahead of print].




Industry News

Gyroscope Receives FDA Fast Track Designation for GT005

Gyroscope Therapeutics announced the FDA granted Fast Track designation to GT005 for the treatment of geographic atrophy secondary to dry age-related macular degeneration. GT005, an investigational one-time AAV-based gene therapy delivered under the retina, is intended to slow the progression of GA. It is targeted to individuals with specific mutations in their Complement Factor I (CFI) gene and low levels of the CFI protein in their blood. Read more.



Apellis Announces Pegcetacoplan Analysis Accepted at EURETINA 2020

Apellis Pharmaceuticals announced that a post hoc analysis of the Phase II FILLY study investigating intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration was accepted as a late-breaking oral presentation by EURETINA 2020 Virtual. The new analysis demonstrates that pegcetacoplan impacts the progression of nascent GA in areas of the retina outside of GA lesions. Read more.



Bausch Health to Acquire Option to Purchase Allegro’s Ophthalmology Assets

Bausch Health Companies announced that Bausch Health (through its affiliate) entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro, including global rights for risuteganib (Luminate). The integrin-regulating therapy is believed to reduce mitochondrial dysfunction involved in intermediate dry age-related macular degeneration. Other ophthalmology assets of Allegro include ALG-1007, a topical integrin regulator under investigation for the treatment of dry eye. The option payment totaling $50 million would be made in two tranches. Read more.



FDA Accepts Emmetrope Ophthalmics' IND Application for EO2002

Emmetrope Ophthalmics announced the FDA accepted its Investigational New Drug application for EO2002, its lead candidate for the treatment of corneal edema. The active IND enables Emmetrope to initiate a Phase I clinical trial to assess the tolerability, safety and efficacy of EO2002 in individuals with corneal edema. EO2002, a first-in-class, non-surgical, magnetic cell-based therapy, was developed by Emmetrope through its exclusive Magnetic Cell Delivery nanoparticle platform. Read more.



Second Sight Resumes Orion Study

Second Sight Medical Products’ Early Feasibility Study of the Orion Visual Cortical Prosthesis System at UCLA Medical Center has resumed. The study was paused for in-person visits following guidelines for clinical trials in March due to COVID-19. Orion is intended to provide useful artificial vision to individuals who are blind due to a range of causes, the company says. It converts images captured by a miniature video camera mounted on glasses into small electrical pulses transmitted wirelessly to electrodes implanted on the brain’s visual cortex. Read more.



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