From the editors of Review of Ophthalmology:
AUGUST IS CHILDREN’S EYE HEALTH/SAFETY MONTH
In this issue: (click heading to view article)
Anti-VEGF vs. Dexamethasone Implant for Center-involved DME
Researchers compared the efficacy and safety of intravitreal anti-vascular endothelial growth factor injection vs. dexamethasone implant (Ozurdex) for the treatment of center-involved DME.
This prospective, randomized, comparative study included 40 eyes (38 individuals) with center-involved DME. Researchers randomized subjects into two groups: Individuals in group A received the intravitreal anti-VEGF injection (bevacizumab 1.25 mg or ranibizumab 0.5 mg) after four weeks, and those in group B received the dexamethasone implant (0.7 mg) pro re nata after three months. The primary outcome, measured at three months from baseline, included improvement in BCVA, reduction in CFT and adverse effects during follow-up. Here are some of the findings:
• Mean best-corrected visual acuity improved from 0.51 ±0.275 logMAR units (20/63) to 0.20 ±0.185 logMAR units (20/32) in group A, and from 0.56 ± 0.213 logMAR units (20/80) to 0.141 ±0.177 logMAR units (20/32) in group B at three months.
• There was no significant difference in mean BCVA between both groups (p=
• The mean central foveal thickness improved from 443.55 ±131.536 µm to 277.66 ±76.184µm in group A, and from 460.95 ±125.462 µm to 233.25 ±37.552 µm at three months in group B (p=
Researchers determined that both groups had similar visual outcomes. However, they noted that the superior anatomical result was observed in dexamethasone implant group during this short follow-up.
SOURCE: Sharma A, Bellala K, Dongre P, et al. Anti-VEGF versus dexamethasone implant (Ozurdex) for the management of centre involved diabetic macular edema (CiDME): A randomized study. Int Ophthalmol 2019; Aug 3. [Epub ahead of print].
Ranibizumab and Polypoidal Choroidal Vasculopathy
Investigators evaluated the real-world effectiveness and safety of intravitreal ranibizumab 0.5 mg in treatment-naive individuals with and without polypoidal choroidal vasculopathy.
They assessed neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the Novartis-sponsored LUMINOUS study. Outcome measures were visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events. Here are some of the findings:
• At baseline, 572 individuals were diagnosed with PCV, and 5,644 patients were diagnosed without PCV.
• The mean visual acuity gain from baseline at month 12 in the PCV group was +5, and the mean visual acuity gain from baseline at month 12 in the non-PCV group was +3 letters; these gains were achieved with a mean of 4.4 and 5.1 ranibizumab injections in the PCV and non-PCV groups, respectively.
• Eighty percent of PCV patients, and 72.2 percent of non-PCV individuals who had baseline visual acuity ≥73 letters maintained this level of vision at month 12; 20.6 percent of PCV patients and 17.9 percent of non-PCV patients with baseline visual acuity <73 letters achieved visual acuity ≥73 letters in these groups.
• Greater reductions in central retinal thickness from baseline were also observed for the PCV group vs. the non-PCV group.
• The rate of serious ocular adverse events was 0.7 percent (PCV group) and 0.9 percent (non-PCV group).
Investigators wrote that LUMINOUS confirmed the effectiveness and safety of ranibizumab in treatment-naive patients with PCV.
SOURCE: Koh A, Lai TYY, Wei WB, et al. Real-world effectiveness and safety of ranibizumab treatment in patients with and without polypoidal choroidal vasculopathy: Twelve-month results from the LUMINOUS study. Retina 2019; Aug 2. [Epub ahead of print].
Lamellar Dissection Technique for DMEK Graft Preparation
Scientists described a novel lamellar dissection technique for Descemet’s membrane endothelial keratoplasty graft preparation, and evaluated the rate of endothelial cell loss and graft preparation failure associated with this technique.
They conducted an ex vivo laboratory-based study comparing ECL between the lamellar dissection and peeling techniques. Eight pairs of human donor corneas underwent calcein acetoxymethyl staining—all right eyes underwent the peeling technique, and all left eyes underwent the lamellar dissection technique. ECL was quantified by image analysis with trainable segmentation software and compared between groups. Scientists also conducted a retrospective analysis of 161 consecutive DMEK graft preparations by a single surgeon using the lamellar dissection technique from 2010 to 2018. Data on donor characteristics and graft preparation failures were obtained. Here are some of the findings:
• Baseline donor characteristics were comparable in both arms of the laboratory-based study.
• Mean ECL with the lamellar dissection and peeling techniques was 13.8 percent ±4.2 percent and 11.2 percent ±6.1 percent, respectively.
• There was no significant difference between the two (p=
• In the clinical series, there were two graft preparation failures in 161 cases (1.2 percent).
• Among cases performed on diabetic donor tissue, the rate of graft preparation failure was 4.7 percent.
Scientists found that the lamellar dissection technique had a similar rate of ECL compared with the peeling technique for DMEK graft preparation. They added that the technique also had a low rate of graft preparation failure and might be a useful technique for diabetic donor tissue.
SOURCE: Tan TE, Devarajan K, Seah XY, et al. Lamellar dissection technique for Descemet membrane endothelial keratoplasty graft preparation. Cornea 2019; Jul 31. [Epub ahead of print].
Older Drivers and Glaucoma in India
Researchers analyzed driving habits of individuals with glaucoma and compared their driving behavior, driving difficulties and accident rates with non-glaucoma controls.
Glaucoma patients over 40 years old were recruited. Subjects with best-corrected visual acuity ≤6/24 in the better-seeing eye and those having a primary eye disorder other than glaucoma were excluded. Age-matched non-glaucoma controls were recruited. Subjects with clinically significant cataract and/or with best-corrected visual acuity ≤6/24 in both eyes were excluded. All cases and controls were legally licensed to drive.
This study used the Driving Habits Questionnaire. Researchers statistically analyzed the collected data using SAS version 9.2 (GLM procedure) and IBM SPSS version 22. P-values <0.05 were considered statistically significant. Here are some of the findings:
• All controls, and 84 percent (n: 84/100) of cases involved current drivers.
• Among them, 16 percent (n: 16/100) of individuals had stopped driving, of which 31.25 percent (n: 5/16) had stopped because of self-reported ocular causes.
• Individuals drove a lesser number of days per week (p=
0.001) and had more driving dependence on other drivers (44 percent, n: 37/84) compared with controls.
• Glaucoma was significantly associated with driving difficulty in the rain, in rush-hour traffic and at night.
• Comparing driving difficulty scores and visual field index within the glaucoma group showed statistical significance [F(1,82)=22.12, p<
• Composite scores of driving difficulty (p<
0.001) and driving space (p=
0.003) between the two groups showed strong statistical significance.
• Controls had a higher number of self-reported accidents (p<
Researchers wrote that individuals with glaucoma showed greater driving difficulty. They also self-regulated driving behavior and restricted their driving. Researchers added that older patients with glaucoma in India weren’t involved in higher rates of on-road crash risks compared with non-glaucoma drivers.
Source: Deshmukh AV, Murthy GJ, Reddy A, et al. Older drivers and glaucoma in india: driving habits and crash risks. J Glaucoma. 2019; Aug 2. [Epub ahead of print].
Research to Prevent Blindness & AAO Award Grants for Big Data Research
The American Academy of Ophthalmology and Research to Prevent Blindness announced this year’s recipients of the Research to Prevent Blindness/American Academy of Ophthalmology Award for IRIS Registry Research. The grant supports researchers who want to conduct big data research in ophthalmology and blindness prevention. These four clinical researchers were selected based on the potential of their original research to advance the Academy’s mission of improving patients’ lives through research and innovation.
• Rishi Singh, MD, Cole Eye Institute, Cleveland Clinic, assistant professor of ophthalmology, Lerner College of Medicine
• Thomas M. Lietman, MD, professor, University of California, San Francisco School of Medicine
• Jennifer Elizabeth Thorne, MD, PhD, professor, Wilmer Eye Institute, Johns Hopkins Bloomberg School of Public Health
• Subhash Aryal, PhD, associate professor, biostatistics & epidemiology, UNT Health Science Center
Glaukos & Avedro Announce Definitive Acquisition Agreement
Glaukos and Avedro announced that the companies entered into a definitive merger agreement under which Glaukos will acquire Avedro in an all-stock transaction. The transaction, which is subject to Avedro stockholder approval along with other customary closing conditions and regulatory approvals, was approved by the boards of directors of both companies and is expected to be completed in the fourth quarter of 2019. Read more.
Kala Dry-eye Application Needs More Efficacy Data
Kala Pharmaceuticals announced that it received a complete response letter from the FDA regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye. The company says that the FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.
Kala continues to enroll patients in its ongoing STRIDE 3 (Short Term Relief In Dry Eye) Phase III clinical trial, and says that it expects this trial will serve as the basis of its response to the CRL. Kala is expecting topline data from STRIDE 3 by the end of this year and resubmission of the NDA during the first half of 2020. Read more.
Eyenuk’s EyeArt Artificial Intelligence System Studied
Eyenuk announced that the peer-reviewed journal Diabetes Technology and Therapeutics published a study in the Aug. 7 online edition of more than 100,000 consecutive diabetic-patient visits analyzed using the EyeArt AI Eye Screening System. The company says that the retrospective study reported that the system achieved greater than 91 percent sensitivity and specificity for detection of referable diabetic retinopathy. The authors, several of which are employees of Eyenuk, say the limitations of the study are its retrospective nature; the potential for misclassification by a single human grader and the lack of adjudicated multiple reader grading for each encounter, which is not possible in such a large study population; and that data on the mean age of the patients or the mean duration of diabetes are unavailable to assess the performance of the EyeArt system, stratified on these factors. Read more.
Macular Degeneration Panel Recommends Paradigm Shift
A panel of 12 investigators assembled by the National Advisory Eye Council called for large-scale collaborative research to address dry macular degeneration. The group recognized the need to investigate the state of research on the disease to guide the direction of future studies in an article published in Nature Communications. Among the ideas proposed were: soliciting integrated collaboration among leading clinicians, imaging experts, basic scientists, bioinformaticians and biostaticians; creating a large biorepository of eye tissue from donors with and without AMD; generating various types of data from disease and normal eye tissue; and designing computer models of the disease. Read more.
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