Review of Ophthalmology Online



Vol. 22, #48  •   Monday, November 22, 2021


In this Issue:




Choroidal Vascularity Index in Pseudoexfoliative Glaucoma

Researchers evaluated the choroidal vascular involvement in pseudoexfoliative glaucoma by applying the choroidal vascularity index (CVI) to optic coherence tomography images.

Seventy-eight eyes from 40 subjects were included the study. Group one included healthy eyes (n=20), group two eyes with pseudoexfoliation (n=16) and group three eyes with PEXG (n=42). OCT imaging of macular and peripapillary regions and retinal nerve fiber layer analyses were performed. CVI was calculated using ImageJ software.

The mean age was 64.89 ±5.8 years in group one, 71.2 ±7.8 years in group two, and 68.24 ±7.4 years in group three (p=0.046). Here are some of the findings:
• No significant differences between the groups in terms of sex (p=0.777) were found.
• In the macula, mean CVI rates were:
   o 66.97 ±1.9 percent in group one;
   o 64.23 ±1.2 percent in group two; and
   o 64.63 ±1.6 percent in group three.
• In the peripapillary areas, mean CVI rates were:
   o 67.04 ±1.5 percent in group one;
   o 65.20 ±1.5 percent in group two;
   o 64.14 ±2.1 percent in group three o (group one vs. group two and three, p=0.000; group two vs. group three, p>0.05).
• The decrease in average RNFL thickness was statistically significant in group three compared to groups one and two.

Researchers found that CVI may be used to assess choroidal vascular changes in ocular diseases since it could be decreased in PEX and PEXG, indicating ocular vascular involvement in the pseudoexfoliative process.

SOURCE: Karslioglu MZ, Kesim C, Yucel O, et al. Choroidal vascularity index in pseudoexfoliative glaucoma. Int Ophthalmol 2021; Dec;41(12):4197-208.




Persistent Hyper-transmission Defects Detected on En Face SS-OCT & Formation of GA

Investigators sought to determine if persistent hyper-transmission defects (hyperTDs)—shown to have a greatest linear dimension (GLD) ≥250 µm on en face swept-source OCT images—serve as a stand-alone early biomarker for the future formation of geographic atrophy.

The post-hoc cohort study using a subgroup of a prospective study included patients with intermediate age-related macular degeneration.

All subjects underwent 6 × 6mm SS-OCT raster scans at baseline and during their follow-up period. En face images were generated using a slab with segmentation boundaries positioned 64 to 400 µm beneath Bruch's membrane. Two graders independently evaluated all en face structural images for the presence of hyperTDs with a GLD ≥250 µm and GA.

A total of 190 eyes were included with a mean follow up of 31 (SD: 13.2) months. Here are some of the findings:
• At baseline, 31 eyes (16 percent) had at least one hyperTD ≥250 µm, and 13 eyes (42 percent) progressed to GA.
• In eyes without a hyperTD ≥250 µm at baseline, 42 (26 percent) developed hyperTDs ≥250 µm during their follow-up and 11 (7 percent) progressed to GA.
• At the last available follow-up visit, 25 eyes (13 percent) progressed to GA and of them, 24 had a prior hyperTD ≥250 µm detected before GA formed.
• A time-dependent Cox-survival regression analysis estimated an eightyfold (CI, 10.7 to 614, p<0.001) increased risk of developing GA once a hyperTD ≥250 µm appeared.

Investigators found that persistent hyperTDs detected on en face OCT images were shown to serve as an early stand-alone OCT biomarker for the future formation of GA.

SOURCE: Laiginhas R, Shi Y, Shen M, et al. Persistent hyper-transmission defects detected on en face swept source OCT images predict the formation of geographic atrophy in AMD. Am J Ophthalmol 2021; Nov 12. [Epub ahead of print].


Corneal Endothelial Cell Damage After Scleral Fixation of IOL Surgery

Scientists analyzed corneal endothelial cell damage after scleral fixation of intraocular lens (SFIOL) surgery, as part of a retrospective study.

Medical records of consecutive eyes undergoing SFIOL surgery performed by a single surgeon were reviewed between January 2011 and June 2019. The patients were classified into three groups according to surgical methods:
• Group I, re-fixating the existing intraocular lens or fixating a new IOL in an aphakic eye;
• Group II, removing an existing IOL and fixating a new one; and
• Group III, phacoemulsification and fixating a new IOL simultaneously. Scientists compared preoperative and postoperative specular microscopy (SM) status among the three groups.

Ninety-four eyes were included: 34 eyes in Group I, 39 in Group II and 21 in Group III. The endothelial cell density (ECD) loss in Group I was 1.5 percent, less than the ECD loss of 14.3 percent (p<0.001) in Group II and 15.4 percent (p=0.005) in Group III. In no eye was there an ECD decrease to <1,000/mm2 following the surgical procedure.

Scientists wrote that ECD loss was related to IOL removal or phacoemulsification rather than SFIOL surgery. They added that SFIOL surgery using the existing IOL is preferred in eyes with low ECD and a dislocated IOL.

SOURCE: Jo YJ, Lee JS, Byon IS, et al. Corneal endothelial cell damage after scleral fixation of intraocular lens surgery. Jpn J Ophthalmol 2021; Nov 9. [Epub ahead of print].


Complimentary CME Education Videos



Correlation of Photoreceptor Integrity with Retinal Vessel Density & Choriocapillaris in DR Eyes

Researchers evaluated the correlation of foveal photoreceptor integrity with the vessel density of the retina and choriocapillaris using swept-source optical coherence tomography angiography in eyes with diabetic retinopathy.

They retrospectively reviewed subjects with DR who underwent OCTA using swept-source OCT (Triton, Topcon). In addition, they:
• analyzed the area of the foveal avascular zone (FAZ), vessel densities of the superficial capillary plexus (SCP), deep capillary plexus (DCP) and choriocapillaris;
• measured the length of the lateral extent of ellipsoid zone (EZ) disruption, central subfield thickness and subfoveal choroidal thickness; and
• analyzed factors closely associated with the length of EZ disruption.

A total of 159 eyes with DR, and 30 healthy control eyes were included in this study. In all eyes, the lengths of EZ disruption were positively correlated with the FAZ area (p=0.009). However, they were negatively correlated with the parafoveal vessel density of the SCP (p=0.049), the foveal vessel density of DCP (p=0.003) and that of the choriocapillaris (p=0.036).

Researchers determined that the size of the FAZ and ischemia at the DCP may play an important role in maintaining foveal photoreceptor integrity in eyes with DR. They added that future studies were needed to reveal the correlation between EZ disruption and the VD of the choriocapillaris, given the issue of OCTA artifacts, such as projection and shadowing.

SOURCE: Kim JT, Park EJ. Correlation of photoreceptor integrity with retinal vessel density and choriocapillaris in eyes with diabetic retinopathy. Retina 2021 Nov 2. [Epub ahead of print].




Industry News

FDA Authorizes New OMNI Study

The FDA has granted an Investigational Device Exemption authorizing Sight Sciences to conduct a clinical study, called PRECISION, to assess the safety and effectiveness of a new, higher volume (21 microliters of viscoelastic fluid dispensed) version of its OMNI device to perform canal viscodilation alone to lower intraocular pressure in adults with primary open-angle glaucoma. Read more.

Regenxbio to Collaborate with AbbVie

Regenxbio announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, an investigational gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases. Under the terms of the agreement, Regenxbio will receive an upfront payment from AbbVie of $370 million with the potential for Regenxbio to receive up to $1.38 billion in additional development, regulatory and commercial milestones. Read more.

Alcon to Acquire Ivantis and its Hydrus Microstent

Alcon announced its intention to acquire Ivantis, developer and manufacturer of the Hydrus Microstent, a currently approved, minimally-invasive glaucoma surgery device designed to lower intraocular pressure for open-angle glaucoma patients in connection with cataract surgery. Read more.

Ocugen Submits IND Application for Gene Therapy Candidate

Ocugen submitted an Investigational New Drug application with the FDA to initiate a Phase I/II clinical trial of OCU400 (AAV-NR2E3), a modifier gene therapy candidate for the treatment of retinitis pigmentosa resulting from genetic mutations found in NR2E3 and RHO. Read more.

Gyroscope Announces Sanofi Investment of Up to $60 Million

Gyroscope Therapeutics Holdings announced Sanofi committed to invest up to $60 million in equity in the company. Under the terms of the agreement, a Sanofi R&D executive will join the Gyroscope Clinical Advisory Board to advise on matters related to the development of GT005 for geographic atrophy secondary to age-related macular degeneration. Additionally, Gyroscope granted Sanofi an exclusive right of first refusal on certain potential future transactions for GT005 in select regions. Read more.

Ocular Therapeutix Announces CMS Update on Dextenza Reimbursement

Ocular Therapeutix announced the Centers for Medicare and Medicaid Services released its final rules for the Outpatient Prospective Payment System and Medicare Physician Fee Schedule for 2022. The OPPS final rule confirms that Dextenza will continue to be separately paid by Medicare in the hospital outpatient department and ambulatory surgical center (ASC) settings for 2022. Read more.

Unity Announces VA Improvement in Phase I Study

Unity Biotechnology announced positive 24-week data from its Phase I single ascending dose safety study of UBX1325 in patients with advanced disease from diabetic macular edema or wet age-related macular degeneration. The company says that most patients with DME across all doses had rapid improvements in vision, and patients in the higher-dose cohorts showed a mean gain of 9.5 ETDRS letters in best-corrected visual acuity at 24 weeks following a single injection of UBX1325. Read more.

J&J Vision’s AAO Plans

Johnson & Johnson Vision will present a range of company-sponsored studies supporting new innovations in its cataract surgery portfolio, at the American Academy of Ophthalmology annual meeting in New Orleans, November 12 to 15. In addition, new company-sponsored research that looks at the accuracy of an artificial intelligence-derived algorithm to assess the cup-to-disc ratio using only a photo will be presented. The company will also support events throughout the week promoting the importance of diversity in the ophthalmology community. Learn more.

Apellis Announces Presentations of Phase III DERBY and OAKS Data in GA

Apellis Pharmaceuticals announced that data from the Phase III DERBY and OAKS studies will be presented as part of three oral presentations at the American Academy of Ophthalmology meeting. The studies evaluated the efficacy and safety of intravitreal pegcetacoplan, an investigational, targeted C3 therapy, in geographic atrophy secondary to age-related macular degeneration. In the studies, monthly and every-other-month pegcetacoplan showed a clinically meaningful reduction of GA lesion growth with a favorable safety profile in a broad population, the company says. Read more.

Prevent Blindness Declares Second Annual TED Awareness Week

Prevent Blindness announced that November 14 to 20 will be the second annual “Thyroid Eye Disease Awareness Week.” The newest episode in the Focus on Eye Health Expert Series, “Thyroid Eye Disease,” will feature Sara Wester, MD, associate professor of clinical ophthalmology, Bascom Palmer Eye Institute, TED specialist and oculoplastic surgeon. Learn more.







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