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Volume 14, Number 18
Monday, May 5, 2014
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In this issue: (click heading to view article)
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######### Effect of High-Dose Subconjunctival Cyclosporine A Implants on CNV After High-Risk Keratoplasty
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######### DSAEK Following Failed PK
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######### Link Between Oral Corticosteroid Use in Adults and Risk of CSC
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######### Low Serum 25-Hydroxyvitamin D and Myopia in Korean Adolescents
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MAY IS ASTHMA AND ALLERGY AWARENESS MONTH



Effect of High-Dose Subconjunctival Cyclosporine A Implants on CNV After High-Risk Keratoplasty

The following prospective, randomized, multicenter, controlled Phase II/III clinical trial comprised 43 trial sites in Germany, India and the United States and tested whether subconjunctival cyclosporine A (CsA) implants affect the incidence and degree of corneal neovascularization (CNV) occurring after penetrating keratoplasty (PK).

A total of 97 patients were enrolled. They were randomized to one of three groups: treatment group A (n=36), treatment group B (n=40), and the control group (n=21). Patients from each group received either of two doses of subconjunctival CsA (group A, low-dose CsA; group B, high-dose CsA) or placebo (carrier only) implants at the time of high-risk PK. For the main outcome measures, the incidence and degree of CNV occurring after PK were evaluated in a substudy (LX201-01 study: NCT00447187). A web-based image upload system was developed. Standardized digital slit-lamp pictures were quantitatively and objectively evaluated using Cell^F morphometry software.

No statistically significant difference in incidence and degree of CNV developing after PK was found between treatment groups and placebo group. Mean CNV area at week 52 (visit 12) was 2.32 ± 1.79% in treatment group A vs. placebo (2.79 ± 2.11%; p=0.45) and 2.74 ± 2.22% in treatment group B vs. placebo (2.79 ± 2.11%; p=0.94).

To conclude, high-dose subconjunctival CsA implants do not significantly affect CNV after high-risk PK. This suggests that local CsA has negligible antiangiogenic effects in the human cornea, at least in the transplant setting.


SOURCE: Bock F, Matthaei M, Reinhard T, et al. High-dose subconjunctival cyclosporine A implants do not affect corneal neovascularization after high-risk keratoplasty. Ophthalmology. 2014;Apr 28. [Epub ahead of print].

 

DSAEK Following Failed PK

Descemet stripping automated endothelial keratoplasty (DSAEK) for isolated endothelial dysfunction has become the preferred surgical option for many corneal surgeons. However, there are limited large-scale reports on DSAEK survival and clinical variables affecting the risk of rejection and failure after failed penetrating keratoplasty (PK).

Here, the authors of a multicenter, retrospective, interventional case series report the survival, risk factors for graft rejection and failure, and visual outcome of DSAEK after failed PK. They included patients recruited from six tertiary referral surgical centers: three in the United States, two in Europe, and one in Asia. A total of 246 consecutive eyes (246 patients) that underwent DSAEK after failed PK, with a minimum follow-up period of one month, were included. Furthermore, data comprising demographic details, preoperative and postoperative risk factors, time to rejection, time to failure, and corrected distance visual acuity were collected. Cumulative probability of graft survival, hazard ratio estimates for survival, and corrected distance visual acuity were determined as the main outcomes and measures.

According to the authors, the mean (SD) recipient age was 63.2 (16.6) years and the median follow-up period was 17 months (interquartile range, six to 30 months). One-third of the grafts (n=82) had follow-up data for more than two years; 18.3% had more than one failed PK before DSAEK. In total, 19.1% (47 of 246) of DSAEK grafts failed. The study authors reported that the cumulative probability of DSAEK survival after a failed PK was 0.89 (95% CI, 0.84 to 0.92), 0.74 (95% CI, 0.64 to 0.81), and 0.47 (95% CI, 0.29 to 0.61) at one year, three years, and five years, respectively. Based on multivariate analysis, they determined that significant preoperative risk factors for failure were young recipient age (hazard ratio [HR], 5.18 [95% CI, 1.57 to 17.18]), previous tube filtration surgery (HR, 5.23 [95% CI, 1.47 to 7.33]), and rejection episodes before PK failure (HR, 3.28 [95% CI, 1.47 to 7.33]); single-surgeon centers had a protective effect. Any rejection episode prior to PK failure was a significant predictor of post-DSAEK rejection, which in turn was a significant predictor of DSAEK failure. After a median follow-up of 17 months, 33.3% of the grafts achieved ≥0.3 logMAR (20/40) corrected distance visual acuity.

DSAEK after failed PK combines greater wound stability and reduced suture-related complications, with visual outcomes and graft survival rates comparable to those of a second PK.

SOURCE: Mitry D, Bhogal M, Patel AK, et al. Descemet stripping automated endothelial keratoplasty after failed penetrating keratoplasty: survival, rejection risk, and visual outcome. JAMA Ophthalmol. 2014;Apr 24. [Epub ahead of print].





Link Between Oral Corticosteroid Use in Adults and Risk of CSC

To investigate the incidence and risk factors for central serous chorioretinopathy (CSC) in adults who use oral corticosteroids in Taiwan, researchers conducted this population-based nested case-control study between 2000 and 2008.

From the Taiwan National Health Insurance Research Database, they included adults who were repetitively prescribed oral corticosteroids as the study cohort. Of those, they identified newly diagnosed CSC cases and then calculated the CSC incidence. The researchers randomly selected subjects matched for age, gender, and the enrollment time as the controls. They compared corticosteroid use between the cases and controls and used Poisson and conditional logistic regressions to analyze the potential risk factors for CSC.

Among 142,035 oral corticosteroids users, the study researchers identified 320 cases of CSC, and randomly selected 1,554 matched controls. The incidence rate of CSC was 44.4 (95% confidence interval [CI], 39.5 to 49.3) cases per 100,000 person-years. Multivariate Poisson regression showed that male patients and those aged 35 years to 44 years had significantly higher incidence rates of CSC. The study researchers noted that there were no differences in either median dosage or mean duration of systemic corticosteroid treatment between the cases and controls. After adjusting for other confounders, current use of oral corticosteroids was found to be significantly associated with the risk of CSCR (odds ratio, 2.40; 95% CI, 1.49 to 3.89).

Male gender, middle age, and current use of oral corticosteroids were risk factors for CSC, the researchers found. However, oral corticosteroids dosage and treatment duration were not associated with the CSC risk.

 


SOURCE: Tsai DC, Chen SJ, Huang CC, et al. Risk of central serous chorioretinopathy in adults prescribed oral corticosteroids: a population-based study in Taiwan. Retina. 2014;Apr 16. [Epub ahead of print].





Low Serum 25-Hydroxyvitamin D and Myopia in Korean Adolescents

Investigators assessed the relationship between serum level of 25-hydroxyvitamin D (25(OH)D) and refractive error in Korean adolescents. They found that low serum 25(OH)D concentration was associated with myopia prevalence in Korean adolescents—particularly in those with high myopia.

A total of 2,038 adolescent aged 13 to 18 years, who participated in the Korea National Health and Nutrition Examination Survey (KNHANES) from 2008 to 2011 underwent refractive examination using an autorefractor. The investigators examined serum 25(OH)D concentration and other potential risk factors. They also performed multivariate regression analysis to investigate the association between serum 25(OH)D and spherical equivalent (SE).

Among the participants, 80.1% had myopia (–0.5D or more myopic) and 8.9% had high myopia (–6.0D or more myopia). Age, total energy/Ca intake, area of residence, parental income, and smoking experience were significantly different among groups according to SE (all, p<0.05). The age-adjusted distribution of SE according to serum 25(OH)D concentration showed a positive relationship (r=0.067, p=0.012). The myopia group had a significant positive relationship between SE and serum 25(OH)D tertile concentration (p=0.020), whereas the nonmyopia group did not have any significant relationship (p=0.599). In multiple linear regression analyses, SE was significantly associated with low serum 25(OH)D concentration after adjustment for area of residence, parental income, total energy intake, dietary Ca intake, milk consumption, and smoking experience (p=0.047). The prevalence of high myopia was significantly associated with the lowest tertile of serum 25(OH)D concentration after adjustment for the confounding factors (p=0.017).


SOURCE: Choi JA, Han K, Park YM, La TY. Low serum 25-hydroxyvitamin D is associated with myopia in Korean adolescents. Invest Ophthalmol Vis Sci. 2014; 55(4):2041–2047.








  • OHR PHARMACEUTICAL COMPLETES ENROLLMENT OF PHASE II CLINICAL TRIAL OF SQUALAMINE EYE DROPS IN WET AMD. Ohr Pharmaceutical has completed the enrollment of its OHR-002 Phase II clinical trial evaluating Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration (AMD). The randomized, double-masked, placebo-controlled study has enrolled 142 patients, and Ohr expects to announce interim data on the first 60 patients completing the protocol in June this year. Final data are expected in the first calendar quarter of 2015. For further details, click here.

  • BAUSCH + LOMB SECURES EXCLUSIVE LICENSE TO 3-D SURGICAL NAVIGATION TECHNOLOGY FOR CATARACT SURGERY. According to a recent press release, Bausch + Lomb has entered into an exclusive licence agreement for a three-dimensional surgical navigation technology, the Cirle Surgical Navigation System, from Cirle Inc. Specifically, Bausch + Lomb has agreed to license the system from Cirle to pursue commercialization for cataract surgery. However, the Surgical Navigation System is not commercially available in the United States at this time.

  • UPDATES ANNOUNCED FOR PHASE III CLINICAL PROGRAM OF LIFITEGRAST IN ADULTS WITH DRY-EYE DISEASE. Shire plc recently presented results from its Phase III OPUS-2 study investigating lifitegrast (5.0% ophthalmic solution) in adults with dry-eye disease, as well as top-line results from the prospective, randomized, double-masked, placebo-controlled, long-term (one year) Phase III SONATA safety study. In the OPUS-2 STUDY, lifitegrast met one of the co-primary endpoints for the patient-reported symptom of improvement in dry eye compared with placebo (p<0.0001), but did not meet the second co-primary endpoint of the sign of inferior corneal staining (p=0.6186). The secondary endpoints were only descriptive in nature and were consistent with improvement in symptoms and lack of improvement in signs. There were no ocular serious treatment-emergent adverse events (TEAEs) or drug-related serious TEAEs reported. The most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2% vs. 0.3% for placebo), instillation site irritation (7.8% vs. 1.4% for placebo), instillation site reaction (7.0% vs. 1.1% for placebo), and visual acuity reduced (5.0% vs. 6.4% for placebo). Additionally, top-line results from the SONATA trial indicated no ocular or drug-related serious adverse events. Read more about these updates here.
  • ENVISU INTRASURGICAL OCT SYSTEM UNVEILED. Bioptigen Inc. recently unveiled its Envisu IntraSurgical OCT for real-time imaging during ophthalmic surgical procedures. Key attributes include a wide, flat scan for accurate structural reproduction, and focal controls that operate independently of the microscope. The Envisu Intrasurgical OCT is modularly designed for compatability with new and existing operating microscopes to extend the power of OCT to surgical ophthalmology. The Envisu Intrasurgical OCT is currently not available for sale, but the company does market the FDA-cleared Envisu C2300 Spectral Domain Ophthalmic Imaging System for handheld and mounted use in clinical and perioperative settings. Visit www.bioptigen.com for additional information.



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