Volume 14, Number 23
Monday, June 9, 2014

In this issue: (click heading to view article)
######### Use of High-Irradiance Accelerated CXL to Treat Keratoconus
######### Impact of Smoking, Drinking and Physical Activity on Vision
######### Efficacy and Safety of Azithromycin 1.5% Eye Drops in a Pediatric Population with Purulent Bacterial Conjunctivitis
######### Severity of Obstructive Sleep Apnea Syndrome and RNFL Thickness
######### Briefly

Use of High-Irradiance Accelerated CXL to Treat Keratoconus

In a private practice in Tokyo, Japan, the authors of this case series evaluated the effectiveness of accelerated corneal collagen crosslinking (CXL) with riboflavin for keratoconus by the change in dioptric power and corneal topography.

They performed the accelerated CXL treatments (KXL system) using a 10-minute riboflavin 0.1% (Vibex Rapid) soak and a three-minute ultraviolet-A (UVA) irradiance at a level of 30 mW/cm². This corresponds to a total radiant exposure of 5.4 J/cm². The authors also performed preoperative and one-, three- and six-month postoperative examinations.

They enrolled 39 eyes of 22 patients and found that the mean uncorrected distance visual acuity showed a statistically significant improvement, from 1.11 ± 0.42 logMAR preoperatively to 0.89 ± 0.53 logMAR six months postoperatively (p<0.01). The mean maximum keratometry readings also changed significantly, from 49.95 ± 6.11D preoperatively to 49.19 ± 5.82D at six months (p<0.01), the authors reported. They observed no statistically significant changes in the endothelial cell density between preoperatively and postoperatively.

In conclusion, the changes after accelerated CXL were similar to those after conventional CXL. Thus, accelerated CXL has the potential to efficiently treat and halt the progression of keratoconus and may be an effective, efficient therapeutic option for treating corneal ectatic disease.

SOURCE: Mita M, Waring GO, Tomita M. High-irradiance accelerated collagen crosslinking for the treatment of keratoconus: six-month results. J Cataract Refract Surg. 2014;40(6):1032–1040.

Impact of Smoking, Drinking and Physical Activity on Vision

To describe the relationships of lifestyle characteristics to changes in vision and incidence of visual impairment (VI) over a 20-year period in the Beaver Dam Eye Study, investigators looked at best-corrected visual acuity (BCVA) measured by a modified Early Treatment Diabetic Retinopathy Study protocol. A cohort of 4,926 persons aged 43 to 86 years participated in the baseline examinations between 1988 and 1990. Follow-up examinations were conducted between 1993 and 1995 (n=3,721); 1998 and 2000 (n=2,962); 2003 and 2005 (n=2,375); and between 2008 and 2010 (n=1,913). The main outcome measures in this longitudinal, population-based cohort study were the change in number of letters read correctly and incidence of VI based on BCVA in the better eye assessed at each examination over a 20-year period.

According to the investigators, the 20-year cumulative incidence of VI was 5.4%. They noted a mean loss of 1.6 letters between examinations, with a 20-year loss of 6.6 letters and, while adjusting for age, income, and age-related macular degeneration (AMD) severity, they found that being a current or past smoker was related to a greater change in the numbers of letters lost. The investigators also reported that persons who had not consumed alcoholic beverages over the past year and sedentary persons had higher odds of incident VI than persons who drank occasionally or who were physically active. For example, in women with early AMD and annual household income less than $10 000, the estimated 20-year cumulative incidence of VI in those who drank occasionally and were physically active was 5.9% compared with 25.8% in women who had not consumed alcoholic beverages over the past year and were sedentary.

Three modifiable behaviors: smoking, drinking alcohol and physical activity were associated with changes in vision. Further evidence that changes in these behaviors will result in less loss of vision is needed because of the expected increase in the burden of VI due to the aging of the population.

SOURCE: Klein R, Lee KE, Gangnon RE, Klein BE. Relation of smoking, drinking, and physical activity to changes in vision over a 20-year period: The Beaver Dam Eye Study. Ophthalmology. 2014;121(6):1220–1228.

Efficacy and Safety of Azithromycin 1.5% Eye Drops in a Pediatric Population with Purulent Bacterial Conjunctivitis

The following multicenter, international, randomized, investigator-masked study in 286 children with purulent discharge and bulbar conjunctival injection aimed at determining the efficacy and safety of azithromycin 1.5% eye drops in a pediatric population with purulent bacterial conjunctivitis.

Patients received either azithromycin 1.5% eye drops (b.i.d. for three days) or tobramycin 0.3% eye drops (q.2.h. for two days, then q.i.d. for five days). Clinical signs were evaluated on days zero, three and seven, and cultures evaluated on days zero and seven. The primary variable was the clinical cure (absence of bulbar conjunctival injection and discharge) on day three in the worse eye for patients with positive cultures on day zero.

A total of 286 patients (mean age 3.2 years; range one day to 17 years) were included; 203 had positive cultures on day zero. Azithromycin was superior to tobramycin in clinical cure rate on D3 (47.1% vs. 28.7%, p=0.013) and was noninferior to tobramycin on day seven (89.2% vs. 78.2%, respectively). Azithromycin treatment eradicated causative pathogens, including resistant species, with a similar resolution rate to tobramycin (89.8% vs. 87.2%, respectively). These results were confirmed in a subgroup of patients younger than 24 months old.

To conclude, azithromycin 1.5% eye drops provided a more rapid clinical cure than tobramycin 0.3% eye drops in the treatment of purulent bacterial conjunctivitis in children, with a more convenient twice-a-day dosing regimen.

SOURCE: Bremond-Gignac D, Nezzar H, Bianchi PE, et al; for the AZI Study Group. Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis. Br J Ophthalmol. 2014;98(6):739–745.

Severity of Obstructive Sleep Apnea Syndrome and RNFL Thickness

Japanese researchers conducted this prospective study to determine whether there is a significant correlation among the peripapillary retinal nerve fiber layer (RNFL) thickness, foveal thickness, total macular volume and severity of obstructive sleep apnea syndrome.

They studied 124 consecutive subjects who underwent polysomnography and used optical coherence tomography (OCT) to measure the peripapillary RNFL, foveal thickness and total macular volume. The researchers also used the Pearson correlation coefficient to determine the relationship between the apnea-hypopnea index and OCT and other parameters. Additionally, they used multiple regression analysis to determine the independent factors for the RNFL sectors that were the most strongly correlated with the apnea-hypopnea index.

The apnea-hypopnea index was significantly and negatively correlated (right eye, r=–0.31, p=0.0004; left eye, r=–0.39, p<0.0001) with the nasal RNFL thickness (Pearson correlation analysis), the researchers found. They discovered that foveal thickness and total macular volume were not correlated. The researchers also observed that intraocular pressure, body mass index, plaque score and incidence of hypertension were negatively correlated, and the lowest oxygen saturation and mean oxygen saturation were positively correlated with the nasal RNFL thickness in the left eye. Multiple regression analysis showed that the apnea-hypopnea index and age were independent contributors to the nasal RNFL thickness in the left eye (apnea-hypopnea index, standard regression coefficient, =–0.30, t value, –2.76, p=0.007; age, –0.24, –2.36, 0.02, respectively). Furthermore, the study researchers found that the nasal RNFL thickness in both eyes decreased significantly based on the severity of the obstructive sleep apnea syndrome.

They determined that exacerbation of obstructive sleep apnea syndrome may produce unique retinal neurodegenerative disorders that decrease the nasal RNFL thickness.

SOURCE: Shiba T, Takahashi M, Sato Y, et al. Relationship between severity of obstructive sleep apnea syndrome and retinal nerve fiber layer thickness. Am J Ophthalmol. 2014; 157(6):1202–1208.

  • FDA APPROVES OMIDRIA FOR USE IN CATARACT AND OTHER IOL REPLACEMENT PROCEDURES. The FDA has approved Omeros Corp.'s Omidria (phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or IOL replacement (ILR) to maintain pupil size by preventing intraoperative miosis and to reduce postop pain. Omeros notes that the approval comes with no post-marketing commitments, other than the previously agreed study of Omidria for use in pediatric patients, which, if successfully completed, makes the drug eligible for an additional six months of marketing exclusivity in the United States. Omidria is a proprietary combination of a mydriatic agent and an anti-inflammatory agent that is added to irrigation solution used during cataract surgery and other ILR procedures. Omeros is now completing preparations for a late summer/early fall 2014 U.S. product launch. Click here for more information.

  • NEW STUDY DATA DEMONSTRATE SAFETY AND DURABILITY OF MICROPULSE TECHNOLOGY FOR GLAUCOMA. In a statement to the press, Iridex Corp. announced that data from a one-year, multicenter study demonstrate the safety and durability of its proprietary MicroPulse technology as a treatment for glaucoma. During an educational symposium at this year's American Society of Cataract and Refractive Surgeons conference, Drs. Ike Ahmed, David Gossage and Elias Reichel reported that the one-year results showed a sustained IOP decrease of 20% to 25%.

  • UNILENS VISION LAUNCHES C-VUE ADDVANTAGE MULTIFOCAL FOR PRESBYOPIA. Unilens Vision Inc. has begun a national rollout of its C-Vue ADDvantage Multifocal for Presbyopia contact lens. The new silicone hydrogel for monthly replacement incorporates the company's highly advanced next-generation multifocal contact lens design technology, which allows for ease of fit by providing a consistent near ADD power across all power profiles, ultimately resulting in clear vision for presbyopes at all distances. According to Unilens, the lens is also thinner and more rounded at the edges for comfort. It's available in a high and a low ADD, and power ranges from +6.00 to –10.00. The C-Vue ADDvantage Multifocal for Presbyopia incorporates an aspheric design with a consistent center ADD power across all power ranges and will be sold exclusively to independent eye-care professionals. Furthermore, Unilens will provide an attractive and user-friendly display cabinet and trial program with a 120-Day Performance Guarantee on the lenses. Click here to find out more.

  • INTRODUCING VOLK OPTICAL'S EYE CHECK. Volk Optical has introduced Eye Check, an electronic, handheld ocular measurement device that aids in the diagnosis of ophthalmic abnormalities. Capable of a various key measurements (e.g., pupil diameter, horizontal visible iris diameter, interpupillary distance, margin reflex distance, pupil eccentricity and strabismus angle), Eye Check helps practitioners screen and document ocular characteristics for contact lens fitting and general diagnostic purposes. Volk says the Eye Check's intuitive user interface is easily navigated by physicians and support staff for seamless integration into the practice environment. The company also says that Eye Check can help to quickly identify patients who are candidates for specialty lenses as well as reduce practice dropout rates. Further information is available here.

  • CENTERVUE RECEIVES FDA CLEARANCE OF NEXT-GENERATION MACULAR INTEGRITY ASSESSMENT. CenterVue Inc. has been granted FDA 510(k) clearance for its next-generation Macular Integrity Assessment (MAIA). The company says MAIA offers the latest advances in scanning laser ophthalmoscopy confocal microperimetry and is intended for measuring macular sensitivity, fixation stability and the focus of the fixation, as well as providing infrared retinal imaging. The additional functions and improved features of the newly enhanced version of the MAIA yield faster examinations. The differences between the redesigned MAIA and its predecessor include: external redesign that is more ergonomic and features a smaller footprint; a more powerful PC; new automatic alignment; and dynamic multifixation. Go to CenterVue's website for further details.

  • USPTO ISSUES NOTICE OF ALLOWANCE COVERING BROMFENAC FORMULATIONS IN DURASITE. InSite Vision Inc. has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for Bromfenac Non-Steroidal Ophthalmic Compositions Formulated in DuraSite. The allowed patent claims contain both composition and method of treatment claims that will broadly cover all of InSite’s bromfenac product candidates, including BromSite ([bromfenac 0.075%] ophthalmic solution formulated in DuraSite, ISV-303) for the treatment of inflammation and prevention of pain post cataract surgery. Additional bromfenac-containing products in InSite's pipeline that will be covered under this patent include: ISV-101 (bromfenac [0.01% to 0.04%] ophthalmic solution formulated in DuraSite) for the treatment of dry-eye disease, back-of-the-eye BromSite indications, such as the prevention of cystoid macular edema, as well as bromfenac and dexamethasone containing products such as BromDex (ISV-504). According to InSite Vision, the patent is expected to provide protection for bromfenac formulations in DuraSite to 2029. Read more at www.insitevision.com.

  • OWL UNVEILS 2014 SUMMER/FALL MENTORING PROGRAM. Ophthalmic Women Leaders (OWL) has launched its restructured, six-month mentoring program for the summer/fall session. OWL is currently accepting mentor and mentee applications through June 30, 2014 and the session, structured to develop meaningful relationships and provide opportunity for mutual professional growth, will begin in early July and continue through January. The program aims to bring together OWL members and connect potential mentors with potential mentees from across ophthalmology to support and learn from one another. Individuals selected for participation will follow a guided program that begins with a kick-off webinar, followed by monthly mentoring meetings conducted in person or by phone/video call, as well as coaching sessions with program facilitators. Visit www.owlsite.org/mentoring for additional information.

  • OHR PHARMACEUTICAL COMPLETES ACQUISITION OF SKS OCULAR. Ohr Pharmaceutical Inc. has reported the closing of its previously announced acquisition of the assets of SKS Ocular LLC. In connection with the transaction, three of SKS Ocular's cofounders (Jason Slakter, MD; Glenn L. Stoller; and Peter K. Kaiser, MD) have been appointed to senior management and advisory roles at Ohr. Along with the acquisition of SKS, Ohr completed a holding company reorganization in which it merged with a wholly owned subsidiary and a new parent corporation succeeded Ohr as a publich holding company under the same name. Want to know more? Visit www.ohrpharmaceutical.com.

  • DR. AGNES WONG RECEIVES INVESTIGATOR AWARD FROM PREVENT BLINDNESS. Prevent Blindness recently announced the recipient of its 2014 Joanne Angle Investigator Award: Agnes Wong, MD, PhD, FRCSC, for the study “Screening for Eye Problems in Preschool Children.” The Joanne Angle Investigator Awards are research grants presented annually to scientifically based studies that seek to end unnecessary vision loss. Read more about the study—and the award— here.

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