From the editors of Review of Ophthalmology:
FEBRUARY IS AGE-RELATED MACULAR DEGENERATION AWARENESS MONTH
In this issue: (click heading to view article)
Six-Year Incidence & Risk Factors for AMD: The Handan Eye Study
Researchers described the six-year incidence of early and late age-related macular degeneration, and associated factors, in a large, rural Chinese population.
The population-based, longitudinal study was conducted in rural China from 2006 to 2007. In total, 6,830 individuals ages 30 years or older participated. The six-year follow-up study was performed between 2012 and 2013. The modified Wisconsin Age-Related Maculopathy Grading System (WARMGS) protocol in the Blue Mountains Eye Study was used as the AMD grading standard.
Excluding 509 deceased subjects, 5,394 (85.3 percent follow-up rate) completed the follow-up. Among them, 5,048 participants had gradable photographs of at least one eye at both exams. Here were some of the findings:
• Over six years, the incidence of early AMD was 4.2 percent (CI, 3.8 to 4.7 percent) and of late AMD was 0.2 percent (CI, 0.2 to 0.3 percent).
• In the multivariable analysis, the per-year increase in age (p
<0.001; OR=1.06; CI, 1.04 to 1.07), male sex (p
=0.006; OR=0.64; CI, 0.47 to 0.88) and per-millimeter increase in axial length (p
=0.010; OR=0.78; CI, 0.63 to 0.94) at baseline was significantly associated with incident early AMD.
• Early AMD wasn’t associated with systolic or diastolic blood pressure, hypertension, diabetes, history of stroke or heart disease, body mass index, total cholesterol, high- or low-density lipoprotein cholesterol, triglycerides, smoking status, refractive error or corneal curvature radius.
• There were too few cases of late AMD for a valid statistical analysis of the risk factors.
Researchers reported that, over six years, the incidence of early AMD was 4.2 percent (CI, 3.8 to 4.7 percent) and of late AMD was 0.2 percent (CI, 0.2 to 0.3 percent). They added that age, sex and axial length were relevant risk factors for early AMD in rural China.
Source: Mao F, Yang X, Yang K, et al. Six-year incidence and risk factors for age-related macular degeneration in a rural Chinese population: The Handan eye study. Invest Ophthalmol Vis Sci 2019;2;60:15:4966-71.
Use of Autologous Serum to Reverse Severe CL-induced Limbal Stem Cell Deficiency
Investigators described the efficacy of autologous serum (AS) eye drops to reverse severe contact lens (CL)-induced limbal stem cell (LSC) deficiency (LSCD), as part of a prospective, uncontrolled, interventional case series.
Fourteen consecutive patients (20 eyes) diagnosed with severe CL-induced LSCD at presentation, based on clinical examination, were enrolled at a tertiary referral center between December 2016 and December 2018. All eyes underwent AS treatment for at least two weeks, with a follow-up of at least two months. Demographic data and treatment outcomes were collected and analyzed.
The mean patient age at presentation was 30.5 years (range: 19 to 49 years). The mean duration of soft contact lens wear was 15.6 ±7.58 years (range: five to 31 years). Here were some of the findings:
• All study eyes had pain and blurred vision at presentation.
• All eyes had recurrent or persistent corneal epithelial defect, stromal scarring and opacity, and superficial vascularization and peripheral pannus at presentation.
• Aggressive treatment with AS succeeded in all eyes.
• Signs and symptoms of LSCD stabilized in all eyes within two weeks; and resolved in six eyes (30 percent) in two weeks, nine eyes (45 percent) in four weeks and five eyes (25 percent) in eight weeks.
• The mean follow-up time was 9.45 ±1.79 weeks (range: eight to 24 weeks).
Investigators concluded that early identification and aggressive treatment of the ocular surface disease with AS could medically reverse severe CL-induced LSCD and prevent the need for surgical intervention.
SOURCE: Yeh S-I, Chu T-W, Cheng H-C, et al. The use of autologous serum to reverse severe contact lens-induced limbal stem cell deficiency. Cornea 2020; Jan 26. [Epub ahead of print].
Researchers Use Smartphone App to Analyze Dry Eye
A research team at Japan’s Juntendo University designed the DryEyeRhythm free mobile app with Apple’s ResearchKit to identify risk factors and characteristics of diagnosed and undiagnosed dry-eye disease. They say the study is among the first to use a crowdsourced smartphone application to collect epidemiological data for dry-eye disease, and the app documented symptoms, medical histories and lifestyle habits of the participants.
The cross-sectional, crowdsourced research included an electronic informed consent step in the app. A total of 21,394 records were identified in the app’s database; 11,485 were duplicate records, and after removing user records outside of Japan or with incomplete data, a cohort of 4,454 participants were enrolled in the study. Of the 4,454 users, 899 participants (27.3 percent) had diagnosed dry eye and 2,395 participants (72.7 percent) had undiagnosed symptomatic dry eye; 2,972 participants (66.7 percent) were women; mean age was 27.9 ±12.6 years.
Participants reported daily subjective symptoms, such as ocular itching, stress levels and headache; and filled out disease-specific questionnaires, such as the Ocular Surface Disease Index (100-point scale; scores 0 to 12 indicate normal; 13 to 22 mild; 23 to 32 moderate; 33 to 100 severe dry-eye symptoms) and the Zung Self-Rating Depression Scale (total of 20 items; total score ranging from 20 to 80; ≥40 highly suggestive of depression).
Study participants were classified as having no symptomatic dry eye (defined as an OSDI total score <13) or having symptomatic dry eye (OSDI ≥13). The symptomatic dry-eye group was further divided into diagnosed and undiagnosed symptomatic dry eye.
The researchers used multivariate-adjusted logistic regression analysis to identify risk factors. They found that risk factors for symptomatic dry eye included younger age, female sex, allergic rhinitis, mental health disorders, digital device screen exposure time and contact lens wear. For undiagnosed symptomatic dry eye, associated risk factors included younger age, male sex, absence of a collagen disease, mental health disorders, ophthalmic surgery and contact lens wear.
The researchers say that one of the advantages of using an app to conduct clinical research is the potential for unlimited participation and no geographical restrictions or participation cost. They add that the identification of associated risk factors offers valuable information that might help to inform targeted health promotion strategies and/or opportunistic screening among those with a greater propensity of developing dry-eye disease, as well as risk factor reduction or modification strategies.
SOURCE: Inomata T, Iwagami M, Kakamura M, et al. Characteristics and risk factors associated with diagnosed and undiagnosed symptomatic dry eye using a smartphone application. JAMA Ophth 2020;138:1:58-68.
HORIZON Trial: Early Postoperative IOP Following Cataract Surgery
In a sub-analysis of data from the the Ivantis-sponsored HORIZON trial, researchers compared early postoperative IOP in individuals who underwent cataract surgery alone with those who underwent cataract surgery combined with implantation of Ivantis’ Hydrus Microstent. The trial included 26 U.S. and 12 international sites.
Included were subjects with mild or moderate primary open-angle glaucoma and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications. A total of 556 subjects were randomized in a 2:1 ratio to undergo cataract surgery alone / no microstent (NMS) vs. cataract surgery with placement of the Hydrus Microstent. All eyes were washed out of IOP-lowering medications prior to surgery and remained unmedicated until surgery. No IOP-lowering prophylaxis was used postoperatively. Comprehensive eye exams were conducted on postoperative day one, week one and month one.
Postoperative IOP >40 mmHg was the primary outcome. Incidence of IOP rise >10 mmHg above baseline unmedicated IOP and mean IOP were analyzed as secondary outcomes.
A total of 369 eyes were randomized to the HMS group, and 187 eyes were randomized to the cataract surgery alone group. The HMS and NMS groups didn’t differ with respect to baseline demographic or ocular characteristics.
• On POD1, the incidence of IOP spikes defined as IOP >40 mmHg was significantly higher at 14.4 percent in the NMS group, compared with 1.4 percent in the Hydrus group (p
• The incidence of IOP rise ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS than in the Hydrus group (22.5 vs. 3 percent, p
• IOP in the NMS group was significantly higher than in the Hydrus group (27.6 vs. 17 mmHg, p
• In multivariable logistic regression analysis, higher baseline IOP predicted higher odds of POD1 IOP spikes >40 mmHg, while presence of the Hydrus was associated with a lower likelihood of postoperative IOP spike.
Researchers found that the addition of a Hydrus Microstent at the time of cataract surgery lowered the risk of markedly elevated IOP in the early postoperative period in glaucoma patients.
SOURCE: Zebardast N, Zheng C, Jampel H, et al. Effect of a Schlemm’s canal microstent on early post-operative IOP following cataract surgery: An analysis of the HORIZON randomized controlled trial. Opthalmology 2019; Jan 22. [Epub ahead of print].
B+L & Clearside Announce Positive Phase III Data on Xipere
Bausch + Lomb with parent company Bausch Health Companies, and Clearside Biomedical announced positive results from the randomized, controlled, double-masked Phase III clinical trial (PEACHTREE) of Xipere (triamcinolone acetonide suprachoroidal injectable suspension), an investigational treatment with a proposed indication of macular edema associated with uveitis. The data, published in Ophthalmology, demonstrated that individuals with noninfectious uveitis in the Xipere study arm experienced clinically significant improvement in vision relative to the control arm. (The control group underwent a sham procedure to maintain masking; the procedure mimicked the suprachoroidal injection, but no drug or vehicle was administered.) The company says this demonstrates the potential efficacy of suprachoroidal injection of Xipere for the treatment of macular edema associated with uveitis. No serious adverse events were reported. Read more.
ProQR Receives FDA Rare Pediatric Disease Designation for QR-421a
ProQR Therapeutics received the FDA’s Rare Pediatric Disease designation for QR-421a for the treatment of retinitis pigmentosa caused by mutations in exon 13 of the USH2A gene. QR-421a is a first-in-class, investigational, RNA-based oligonucleotide designed to address the underlying cause of vision loss in Usher syndrome type II and non-syndromic retinitis pigmentosa due to mutations in exon 13 of the USH2A gene. The RPD designation provides FDA priority review to encourage treatments for rare pediatric diseases, the company says. Read more.
Aldeyra Appoints Dr. Karpecki to Advisory Board
Aldeyra Therapeutics announced the appointment of Paul Karpecki, OD, FAAO, to the company’s Anterior Segment Scientific Advisory Board (SAB). Dr. Karpecki is clinical director, corneal services and advanced ocular surface disease at Kentucky Eye Institute and a clinician for Gaddie Eye Centers. He is an associate professor at the Kentucky College of Optometry and medical director for Keplr Vision and the Dry Eye Institutes of Kentucky and Indiana. Dr. Karpecki is also the chief medical editor for Review of Optometry, and has moderated or chaired the Congressional Hearing on the Impact of Dry Eye Disease, the Tear Film and Ocular Surface Society Symposium and the Dry Eye Summit. He has served on the International Task Force on Dry Eye and the TFOS DEWS II Diagnostic Methodology sub-committee, and is a TFOS Global Ambassador. Dr. Karpecki has authored more than 20 peer-reviewed papers and more than 300 articles in non-peer reviewed journals, as well as seven book chapters. Read more.
Glauconix Promotes Southern to CEO
Glauconix Biosciences announced that its board of directors appointed Kim Southern as chief executive officer and a board member. Southern previously held the position of chief operating officer. Since joining the company in May, she has furthered the corporate focus on the development of additional bioengineered human 3D tissue models to support needs beyond glaucoma, the company says. Learn more about Glauconix.
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