Review of Ophthalmology Online


Volume 18, Number 43
Monday, October 22, 2018


In this issue: (click heading to view article)
######### Corneal Densitometry as a Predictive Tool for VA Following DMEK
######### OCT Biomarkers to Distinguish DME From Pseudophakic Cystoid ME Using Machine Learning Algorithms
######### Binocular VF Loss & Stages of Monocular VF Damage in Glaucoma
######### Efficacy & Safety of Sarilumab for Noninfectious Uveitis: Phase II SATURN Trial


Corneal Densitometry as a Predictive Tool for VA Following DMEK

Researchers looked at correlations between preoperative corneal backscatter and visual acuity results following Descemet’s Membrane Endothelial Keratoplasty in eyes with corneal endothelial disorders, as part of a retrospective, interventional case series.

The first 551 consecutive DMEKs of the Center of Ophthalmology, University of Cologne, with preoperative corneal densitometry values (corneal light backscatter measured in greyscale units) measured by the Scheimpflug-based Oculus Pentacam corneal densitometry module were screened for eligibility. Researchers retrospectively correlated best spectacle-corrected VA results with densitometry data. Densitometry data were obtained in four corneal layers (anterior, central, posterior and total) and four annuli. Researchers correlated pre- and postoperative BSCVA results with densitometry data, and performed ROC analyses.

A total of 412 eyes were available for analysis. VA results improved significantly following DMEK surgery at three, six, 12 and 24 months follow-up (p<0.001). Corneal backscatter moderately correlated with preoperative BSCVA results. Associations were primarily found between densitometry values of the anterior and central layers, and more pronounced in the central cornea for all postoperative time points. The posterior layer correlated least with postoperative gains in BSCVA. ROC analyses revealed the best predictive power of densitometry values to be in 2 to 6 mm of the cornea in the annular zone.

Researchers concluded that corneal backscatter in eyes with corneal endothelial disorders correlated with postsurgical BSCVA results following DMEK surgery. They added that early DMEK surgery seemed to have a positive impact on long-term BSCVA results.

SOURCE: Schaub F, Gerber F, Adler W, et al. Corneal densitometry as predictive diagnostic tool for visual acuity results following Descemet membrane endothelial keratoplasty. Am J Ophthalmol 2018; Oct 10. [Epub ahead of print].

OCT Biomarkers to Distinguish DME From Pseudophakic Cystoid ME Using Machine-learning Algorithms

Investigators wrote that identifying underlying pathology in diabetic individuals presenting with macular edema soon after cataract surgery could be challenging and could influence management. They aimed to develop a clinical classifier to confirm diabetic etiology using spectral-domain optical coherence tomography parameters.

Investigators analyzed SD-OCT data of 153 individuals with pseudophakic cystoid (n=57), diabetic ME (n=86) or “mixed” (n=10) ME. They used advanced machine learning algorithms to develop a predictive classifier with few parameters.

Differentiating factors included the existence of hard exudates, hyperreflective foci and subretinal fluid, along with ME patterns and location of cysts within retinal layers. Using three to six SD-OCT parameters, investigators achieved a 94 to 98 percent sensitivity, 94 to 95 percent specificity, and an area under the curve of 0.937 to 0.987 (depending on the method) for confirming diabetic etiology. A decision flowchart achieved a 96 percent sensitivity, a 95 percent specificity and an area under the curve of 0.937.

Investigators found that confirming diabetic etiology for edema in cases with uncertainty between diabetic cystoid ME and pseudophakic ME was possible using few SD-OCT parameters with high accuracy. They proposed using a clinical decision flowchart for cases with uncertainty to support the decision for intravitreal injections rather than topical treatment.

Source: Hecht I, Bar A, Rokach L, et al. Optical coherence tomography biomarkers to distinguish diabetic macular edema from pseudophakic cystoid macular edema using machine learning algorithms. Retina 2018; Oct 3. [Epub ahead of print].

Binocular VF Loss & Monocular VF Damage in Glaucoma

Scientists assessed monocular visual field loss and binocular VF loss in primary angle-closure, primary open-angle and normal-tension glaucoma, in an observational, cross-sectional study.

A total of 250 individuals with glaucoma and 31 healthy participants were assigned to groups by stages of monocular VF loss in both eyes; normal, early, moderate or severe. (Binocular VF assessments were determined via integrated VF and Esterman binocular visual evaluations.) Monocular and binocular VF parameters were compared within and between groups.

• Average integrated mean deviation (SD) in individuals with one eye at the normal or early stage was -1.67 (1.39) dB, or -3.27 (2.05) dB in individuals with one eye at the severe stage.
• Average Esterman scores were >95 percent: 99.17 percent (1.89 percent) in individuals with one eye at the normal or early stage, and 96.08 percent (3.99 percent) with one eye at the severe stage.
• In cases where both eyes had progressed to moderate or severe damage (moderate/moderate, moderate/severe or severe/severe), the average integrated mean deviations were worse than -6 dB, and the mean Esterman scores in the moderate/moderate (94.20 percent [5.96 percent]) and moderate/severe damage groups (94.32 percent [4.95 percent]) were >90 percent, but dropped rapidly from >90 percent to 68.44 percent (26.27 percent) when both eyes were at the severe stage.

Scientists wrote that the binocular VF could remain relatively intact provided one eye was at the normal or early stage. They wrote further that significant binocular VF defects measured by integrated mean deviation were evident when both eyes had progressed to the moderate or severe stage, and significant Esterman binocular VF defects were only detected when both eyes had advanced to the severe stage.

SOURCE: Xu J, Lu P, Dai M. The relationship between binocular visual field loss and various stages of monocular visual field damage in glaucoma patients. J Glaucoma 2018; Oct 8. [Epub ahead of print].

Efficacy & Safety of Sarilumab for Noninfectious Uveitis: Phase II SATURN Trial

Researchers evaluated the efficacy and safety of sarilumab, a human anti-interleukin-6 receptor antibody, for the treatment of noninfectious uveitis of the posterior segment, as part of a randomized, double-masked, placebo-controlled, Phase II study. Participants included 58 eyes with noninfectious intermediate, posterior or pan-uveitis. Eyes were randomized 2:1 to treatment q2 weeks for 16 weeks with subcutaneous sarilumab 200 mg or placebo. The primary endpoint was the proportion of individuals with ≥2-step reduction in vitreous haze (VH) on the Miami scale, or reduction of systemic corticosteroids (prednisolone or equivalent) to a dose of <10 mg/day at week 16. The primary endpoint was based on VH evaluation by a central reading center. Investigator evaluation of VH was a pre-specified, secondary analysis.

• At week 16, the proportion of cases with ≥2-step reduction in VH or corticosteroid dose <10 mg/day was 46.1 percent using sarilumab vs. 30 percent on placebo (p=0.2354), based on central reading center assessments of VH; and 64 percent using sarilumab vs. 35 percent on placebo (p=0.0372) based on investigator assessment of VH.
• In eyes with VH ≥grade 2 at baseline, the mean VH reduction from baseline to week 16 was significantly greater with sarilumab (-2.1 [n=11]) vs. placebo (-1.7 [n=3])(p=0.0255), regardless of assessments by central reading centers; and regardless of assessments by investigators: -2.5 (n=19) for sarilumab vs. -1.2 (n=11) for placebo (p=0.0170).
• The mean best-corrected visual acuity gain from baseline to week 16 was greater with sarilumab (8.9 letters) vs. placebo (3.6 letters)(p=0.0333) in the overall population and in the subgroup of eyes with central subfield thickness ≥300 μm: 12.2 letters (n=13) in sarilumab vs. 2.1 letters (n=7) in placebo (p=0.0517).
• Corresponding changes in CST were: -46.8 with sarilumab vs. +2.6 μm in controls (p=0.0683) in the overall population; and -112.5 (n=13) with sarilumab vs. -1.8 (n=6) μm in controls (p=0.1317) in eyes with CST ≥300 μm at baseline.
• The most common ocular adverse events were worsening of uveitis (three individuals on sarilumab) and retinal infiltrates (two on sarilumab and one taking placebo).

Researchers determined that subcutaneous sarilumab might provide clinical benefits in the management of non-infectious uveitis of the posterior segment, especially in eyes with uveitic macular edema.

SOURCE: Heissigerová J, Callanan D, de Smet MD, et al. Efficacy and safety of sarilumab for noninfectious uveitis of posterior segment: outcomes from the Phase 2 SATURN Trial. Ophthalmology 2018; Oct. 11. [Epub ahead of print].

  • FDA Approves EyePoint’s YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg
    EyePoint Pharmaceuticals announced that the FDA approved YUTIQ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ is a non-bioerodible intravitreal microinsert in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release consistently over 36 months. The implant is supplied in a sterile, single-dose preloaded applicator that can be administered in the physician's office. In clinical trials, YUTIQ significantly reduced the rate of recurrent uveitis flares vs. sham, and the most common adverse reactions reported were cataract development and an increase in intraocular pressure. Read more.

  • Topcon Introduces Cloud Backup & Archive Solution
    Topcon Healthcare Solutions released Topcon Cloud, an add-on module for Topcon devices with the IMAGEnet 6 software. The system is intended for the secure backup and archiving of exam data in the cloud and enables native integration with Topcon devices, eliminating the need for manual backups. It was designed to be easy to install, configure, set up and scale. Read more.

  • ImprimisRx to Feature New Formulation & MKO Melt Poster at AAO
    Attendees at the 2018 American Academy of Ophthalmology annual meeting in Chicago (Oct. 26-30) can meet with ImprimisRx representatives at Booth #4254 to learn about the company’s portfolio of formulations, including a new tropicamide and phenylephrine combination topical offering. In addition they can learn more about the MKO Melt (midazolam/ketamine/ondansetron), a noninvasive, non-opioid, patented, sublingual troche typically used by physicians for short-term procedures, during a poster presentation. Read more.

  • Oculus Keratograph 5M Features New Joystick With Release Function
    The Oculus Keratograph 5M, now equipped with a joystick and release function, enables the user to capture images and video sequences with the push of a button, without the need to switch to the mouse, Oculus says. The wireless joystick communicates with the Keratograph software via Bluetooth. A power supply cabling configuration inside the xy-base enables users to retrofit existing systems. Read more.

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