#########
Volume 12, Number 18
Monday, April 30, 2012
#########





In this issue: (click heading to view article)
#########
######### OCT for the Detection of New-Onset CNV

#########
######### Cost Comparison of Medications and Laser Trabeculoplasty for Newly Diagnosed OAG
#########
######### Impact of Adding Risk Factors to Assessment of Rates of Glaucomatous Progression
#########
######### Systemic Treatment with Isotretinoin and its Associated Ocular Adverse Effects
#########
######### Briefly

 

 





OCT for the Detection of New-Onset CNV

The authors of this prospective, multicenter, observational study sought to determine the sensitivity of time domain optical coherence tomography (OCT) in detecting conversion to neovascular age-related macular degeneration (AMD) in eyes at high risk for choroidal neovascularization (CNV), compared with detection using fluorescein angiography (FA) as the gold standard.

They included individuals aged ≥ 50 years with non-neovascular AMD at high risk of progressing to CNV in the study eye and evidence of neovascular AMD in the fellow eye. The study authors noted that at study entry and every 3 months through 2 years, participants underwent best-corrected visual acuity, supervised Amsler grid testing, preferential hyperacuity perimetry (PHP) testing, stereoscopic digital fundus photographs with FA, and OCT imaging. A central Reading Center graded all images. Main outcome measures included the sensitivity of OCT in detecting conversion to neovascular AMD by 2 years, using FA as the reference standard. Secondary outcomes included comparison of sensitivity, specificity, positive predictive value, and negative predictive value of OCT, PHP, and supervised Amsler grid relative to FA for detecting incident CNV.

The authors enrolled 98 participants; 87 (89%) of these individuals either completed the 24-month visit or exited the study after developing CNV. They noted that 15 (17%) study eyes had incident CNV confirmed on FA by the Reading Center. The sensitivity of each modality for detecting CNV was: OCT 0.40 (95% confidence interval [CI], 0.16–0.68), supervised Amsler grid 0.42 (95% CI, 0.15–0.72), and PHP 0.50 (95% CI, 0.23–0.77). The authors recommended treatment for incident CNV in 13 study eyes. Sensitivity of the testing modalities for detection of CNV in these 13 eyes was 0.69 (95% CI, 0.39–0.91) for OCT, 0.50 (95% CI, 0.19–0.81) for supervised Amsler grid, and 0.70 (95% CI, 0.35–0.93) for PHP. Specificity of the OCT was higher than that of the Amsler grid and PHP.

Time-domain OCT, supervised Amsler grid, and PHP have low to moderate sensitivity for detection of new-onset CNV compared with FA, the authors concluded. They also found that OCT has greater specificity than Amsler grid or PHP. Among fellow eyes of individuals with unilateral CNV, FA remains the best method to detect new-onset CNV.

SOURCE: Do DV, Gower EW, Cassard SD, et al. Detection of new-onset choroidal neovascularization using optical coherence tomography: the AMD DOC Study. Ophthalmol. 2012;119(4):771–778.




http://ecatalog.alcon.com/PI/Nevanac_us_en.pdf







Cost Comparison of Medications and Laser Trabeculoplasty for Newly Diagnosed OAG

In the following study, researchers aimed to determine the most cost-effective treatment option for patients with newly diagnosed mild open-angle glaucoma (OAG): observation only, treatment with generic topical prostaglandin analogs (PGAs) or treatment with laser trabeculoplasty (LTP).

Using a Markov model with a 25-year horizon, they compared the incremental cost-effectiveness of the three treatment options listed. The researchers found that the incremental cost-effectiveness of LTP over no treatment is $16,824 per quality-adjusted life year. By comparison, the incremental cost-effectiveness of PGAs over no treatment is $14,179 per quality-adjusted life year, and they provide greater health-related quality of life relative to LTP. If PGAs are 25% less effective owing to poor patient adherence, LTP can confer greater value.

In conclusion, prostaglandin analogs and LTP are both cost-effective options for the management of newly diagnosed mild open-angle glaucoma. Assuming optimal medication adherence, PGAs confer greater value compared with LTP. However, when assuming more realistic levels of medication adherence (making them 25% less effective than the documented effectiveness reported in clinical trials), at current prices for PGAs, LTP may be a more cost-effective alternative.

SOURCE: Stein JD, Kim DD, Peck WW, et al. Cost-effectiveness of medications compared with laser trabeculoplasty in patients with newly diagnosed open-angle glaucoma. Arch Ophthalmol. 2012;130(4):497–505.








Impact of Adding Risk Factors to Assessment of Rates of Glaucomatous Progression

To present and evaluate a new method of integrating risk factors into the analysis of rates of visual field progression in glaucoma, this study included 352 eyes of 250 glaucoma patients followed up for an average of 8.1 ± 3.5 years.

Slopes of change over time were evaluated by the mean deviation (MD) from standard automated perimetry. For each eye, the follow-up time was divided into two equal periods: the first half was used to obtain the slopes of change and the second period was used to test the predictions. Slopes of change were calculated with two methods: the conventional approach of ordinary least squares (OLS) linear regression and a Bayesian regression model incorporating information on risk factors and presence of progressive optic disc damage on stereophotographs. The mean square error (MSE) of the predictions was used to compare the predictive performance of the different methods.

It was reported that higher mean IOP, thinner central corneal thickness (CCT) and presence of progressive optic disc damage were associated with faster rates of MD change. Additionally, incorporation of risk factor information into the calculation of individual slopes of MD change with the Bayesian method resulted in better prediction of future MD values than with the OLS method (MSE: 4.31 vs. 8.03, respectively; p < 0.001).

A Bayesian regression model incorporating structural and risk factor information into the estimation of glaucomatous visual field progression resulted in more accurate and precise estimates of slopes of functional change than the conventional method of OLS regression.

SOURCE: Medeiros FA, Zangwill LM, Mansouri K, et al. Incorporating risk factors to improve the assessment of rates of glaucomatous progression. Invest Ophthalmol Vis Sci. 2012;53(4):2199–2207.

 



http://www.revophth.com/ResFellowEdu2012






Systemic Treatment with Isotretinoin and its Associated Ocular Adverse Effects

Investigators conducted a retrospective cohort study using the electronic medical databases of a large health maintenance organization in Israel to examine whether isotretinoin therapy could result in deleterious ocular effects, as previously described in case report studies.

The study population consisted of 14,682 adolescents and young adults who were new users of isotretinoin for acne and 2 age- and sex-matched comparison groups (isotretinoin-naive patients with acne and acne-free patients). Main outcome measures were ocular adverse effects (AEs) or purchases of ophthalmic medications within 1 year after the first dispensed isotretinoin prescription.

The study investigators noted that in total, 13.8% of the isotretinoin group experienced ocular AEs vs 9.6% of the isotretinoin-naive group and 7.1% of the acne-free group. They also found that during a 1-year follow-up period, the isotretinoin group had significantly higher risk for any ocular AEs (hazard ratio, 1.70; p < .001) compared with the acne-free group. They observed no such increased risk for the isotretinoin-naive group. Furthermore, the isotretinoin group had higher relative risks for inflammatory and structural AEs.

According to the investigators, isotretinoin use may be associated with short-term ocular events, especially conjunctivitis, underscoring the importance of educating patients and caregivers about these potentially important AEs of the therapy.

SOURCE: Neudorfer M, Goldshtein I, Shamai-Lubovitz O, et al. Ocular adverse effects of systemic treatment with isotretinoin. Arch Derm. 2012; Apr 16. [Epub ahead of print].











 




  • CARL ZEISS TO BEGIN CLINICAL TRIAL OF NEW ALL-FEMTO LASER VISION CORRECTION METHOD. According to a recent press release, Carl Zeiss Meditec intends to initiate a U.S. clinical trial of the ReLEx smile procedure for the correction of myopia, having received conditional approval for the trial from the FDA. It expects to start enrolling patients within the next few months. The company developed the new ReLEx smile technique for refractive surgery. The technique combines femtosecond laser technology and precise lenticule extraction for minimally invasive laser vision correction in one system: the VisuMax Femtosecond Laser from Carl Zeiss Meditec.
  • ISTA PROVIDES HIGHLIGHTS OF RESULTS FROM PROLENSA TRIAL. ISTA Pharmaceuticals, Inc. recently presented results from one of two Phase 3 studies of Prolensa (bromfenac ophthalmic solution), the company's once-daily topical nonsteroidal anti-inflammatory product candidate for the treatment of ocular inflammation and pain following cataract surgery. The findings showed that Prolensa was statistically greater than placebo in clearing subjects' ocular inflammation by Day 15 and eliminating ocular pain one day post-surgery, which were the study's primary and secondary endpoints, respectively. These data were presented in a poster session at this year's American Society of Cataract and Refractive Surgery conference. Additional data from the poster presentation, titled “Phase III Clinical Trial of Low Concentration Bromfenac Ophthalmic Solution Dosed Once Daily for Postoperative Ocular Inflammation and Pain”, demonstrated there were no serious drug-related ocular or systemic adverse events, and Prolensa's safety profile was consistent with ISTA's currently marketed once-daily topical nonsteroidal anti-inflammatory (NSAID) compound, Bromday (bromfenac ophthalmic solution) 0.09%. The company intends to file a New Drug Application (NDA) with the FDA for Prolensa in the first half of 2012. Learn more about the Phase 3 program and its results here.
  • NEW EXCIMER LASER FROM ALCON. Alcon has introduced its latest innovation in LASIK surgery technology, the WaveLight EX500 excimer laser. The 500 Hz pulse frequency laser is capable of a 1.4 sec/diopter ablation. In addition to offering fast performance and a broad range of customization for patient-specific treatments, the WaveLight EX500 excimer laser is also equipped with advanced safety features including a 1050 Hz eye tracker synchronized with the laser. The new laser, which was approved for sale in the United States by the FDA in the fourth quarter of 2011, also delivers an upgradeable platform, with an advanced multi-dimensional 1050 Hz tracker synchronized at 500 Hz, non-contact dynamic pachymeter and a communication-ready small/sleek footprint.
  • BAUSCH + LOMB EXPANDS LINE OF SURGICAL HANDPIECES. At this year's American Society of Cataract and Refractive Surgery conference, Bausch + Lomb announced that the silicone CapsuleGuard IA line has expanded from two to 10 single-use instruments, offering cataract surgeons a wider range of options for both incisions and techniques for irrigation and aspiration. According to the company, the new expanded line now offers surgeons the smaller, MICS 1.8 incision option in addition to the standard 2.2 to 2.8 incision ranges. The CapsuleGuard IA line is compatible with Basuch + Lomb's Stellaris PC Vision Enhancement System as well as other ophthalmic surgical platforms and is available in the United States, Canada, Europe, Malaysia, Hong Kong, Australia and India. For more details, visit www.bausch.com.
  • PHASE I CLINICAL STUDY OF TREATMENT FOR HYPOTRICHOSIS OF THE EYELASHES COMPLETED. R-Tech Ueno has announced the completion of a phase I clinical study of a new compound, RK-023, being developed for the treatment of hypotrichosis of the eyelashes. RK-023 is a novel physiologically active fatty acid derivative that R-Tech Ueno has been developing for the treatment of dermatological diseases. The company has completed a placebo-controlled, double-blind phase I clinical study of the compound as part of its development effort for the treatment of hypotrichosis of the eyelashes. The study evaluated the safety, tolerability and pharmacokinetics of RK-023 in eight healthy adult males and females (16 subjects total) by applying the study drug to the eyelid margin of the subjects for 5 consecutive days. No adverse drug reactions or ophthalmological findings (such as lowering ocular pressure and ocular hyperemia) were observed. Click here to read more.

 


Review of Ophthalmology® Online is published by the Professional Publications Division of Jobson Medical Information LLC (JMI), 11 Campus Boulevard, Newtown Square, PA 19073.

To subscribe to other JMI newsletters or to manage your subscription, click here.

To change your email address, reply to this email. Write "change of address" in the subject line. Make sure to provide us with your old and new address.

To ensure delivery, please be sure to add reviewophth@jobsonmail.com to your address book or safe senders list.

Click here if you do not want to receive future emails from Review of Ophthalmology Online.

Advertising: For information on advertising in this e-mail newsletter or other creative advertising opportunities with Review of Ophthalmology, please contact publisher Rick Bay, or sales managers James Henne or Michele Barrett.

News: To submit news or contact the editor, send an e-mail, or FAX your news to 610.492.1049