
A
weekly e-journal by Art Epstein, OD, FAAO
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Volume 10, Number 11 |
Monday, March 22, 2010 |
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Off the Cuff: Lessons from the Great Wall
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| Clinical Evaluation of Systane Ultra Safety in Contact Lens Wearers | ||||
This investigator- and patient-masked, single-site, randomized, and prospective study involved
45 successful contact lens wearers to evaluate the safety of Systane Ultra Lubricant Eye Drops in contact
lens wearers. A currently marketed contact lens rewetting drop was the control solution. Eligible
subjects' baseline biomicroscopy findings, visual acuity, and corneal staining score were recorded.
Subjects received either the test or control solution with masked labeling. Subjects were instructed to
instill their assigned solution in both eyes: 15 minutes prior to lens insertion, at least one drop
during lens wear and another drop immediately following lens removal. After 14 days, biomicroscopy
results, visual acuity, and corneal staining score were recorded.
No adverse events were documented for either the test or the control solution. For subjects using Systane Ultra, no statistically significant change was detected in visual acuity or corneal staining score. For subjects using the control solution, the change in visual acuity was not clinically relevant and there was no significant change in corneal staining score. This clinical study provided evidence of safety and compatibility of Systane Ultra Lubricant Eye Drops in contact lens wearers. |
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SOURCE: Kading D. A two-week clinical evaluation of the safety of Systane Ultra in contact lens-wearing patients. Clin Ophthalmol 2010;4:27-32. |
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| Success Rates of Retinal Buckling Surgery: Relationship to Refractive Error and Lens Status | ||||
This study was designed to first evaluate the anatomic success rates of
scleral buckling surgery in the treatment of rhegmatogenous retinal detachment and possible
differences in outcome depending on patients' refractive error and lens status and second,
to evaluate demographic characteristics of patients with retinal detachment to contribute to
our knowledge of the epidemiology of this important and sight-threatening disease. The
Munster Study on Therapy Achievements in Retinal Detachment (MUSTARD) is one of the largest
case series of patients with retinal detachment and their outcome after buckling surgery
ever established, with 4325 subjects who underwent surgery between 1980 and 2001.
The overall success rate in all 4325 MUSTARD cases was 83.98%. The highest success rate was achieved in patients aged 51 to 60 years, with 86.72%. With regard to refractive error, success rates were highest in moderate myopes, that is, in 707 patients with a refractive error between -2.75 and -8.0 D (86.70%) and in 573 patients with mild myopia between -0.5 and -2.0 D (86.21%). The lens status did not play a significant role in outcome. In patients with nontrauma-related retinal detachment, success rates were 84.45% for phakic patients, 82.88% for pseudophakic patients, and 81.88% for aphakic patients. An epidemiologically surprising result was the lower than expected number of myopic individuals among patients with retinal detachment: Only approximately one quarter had myopia of -2.75 D or more. In phakic patients aged 51 to 80 years, only 16% were myopic. Scleral buckling is an established and generally successful method for the treatment of retinal detachment. As our case series has demonstrated, myopia, aphakia, and pseudophakia do not constitute factors that might diminish the chances of success. |
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SOURCE: Thelen U, Amler S, Osada N, Gerding H. Success rates of retinal buckling surgery: relationship to refractive error and lens status: results from a large German case series ophthalmology. 2010;Mar 4 [Epub ahead of print]. |
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| Effect of Patient-Centered Communication Training on Discussion and Detection of Non-adherence in Glaucoma | ||||
Sociolinguistic analysis of videotaped community ophthalmologists encounters
with patients with glaucoma before and after training were evaluated to assess communication
about adherence and to determine the impact of communication skills training on physicians'
approach to non-adherence. Patients in both phases and physicians in phase I knew communication
was being studied but not what the focus of the study was. In phase II, physicians knew the targeted communication behaviors. The subjects included 23 ophthalmologists and 100 regularly scheduled patients
with glaucoma (50 per phase). An educational program with videotaped vignettes of simulated patient
encounters using audience response and role play to teach patient-centered communication skills,
including a 4-step adherence assessment and the use of open-ended questions in
ask-tell-ask sequences. Physician eliciting an acknowledgment of non-adherence
during a clinical encounter compared with acknowledgment of non-adherence during a
post-visit research interview (primary outcome), and performance of targeted communication
and substantive discussion of adherence were assessed.
After intervention, physicians increased the proportion of open-ended questions (15% vs 6%) and specifically about medication taking (82% compared with 18% of encounters). Compared with the absence of ask-tell-ask communication, 32% of phase II encounters included a complete ask-tell-ask sequence, 78% included an ask-tell sequence, and 32% a tell-ask sequence. Three of 4 steps for assessment of adherence were more common in phase II, and substantial discussions of adherence occurred in 86% versus 30% of encounters. In phase II, physicians elicited acknowledgment of non-adherence in 78% (7/9) of those who acknowledged non-adherence in the post-visit interview compared with 25% in phase I (3/12). This study demonstrates that experienced community physicians significantly improved their communication strategies and ability to detect and address non-adherence after a 3-hour educational program. |
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SOURCE: Hahn SR, Friedman DS, Quigley HA, et al. Effect of patient-centered communication training on discussion and detection of nonadherence in glaucoma. Ophthalmology 2010; Mar 6 [Epub ahead of print]. |
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| News & Notes | ||
| RESULTS FROM PHASE 2 BLEPHARITIS TRIALS ANNOUNCED. Inspire Pharmaceuticals, Inc. has reported the results from two Phase 2 clinical trials with Azasite (azithromycin ophthalmic solution) 1% for the treatment of blepharitis. Both trials consisted of patients with anterior blepharitis; one with a two-week treatment period and one with a four-week treatment period. They were designed to study a variety of endpoints and different dosing durations to more fully understand the potential of Azasite for the treatment of blepharitis. In both trials, the Azasite treatment group and the vehicle treatment group showed statistically significant improvements relative to baseline for all measured signs and symptoms of blepharitis. Azasite was well tolerated in both trials as well. The company plans to conduct additional clinical work to continue pursuing a potential indication for treatment of anterior and posterior forms of blepharitis. Additional information can be found here. | ||
| FDA ISSUES FAST TRACK DESIGNATION FOR INVESTIGATIONAL DRY AMD TREATMENT. Acucela Inc. and Otsuka Pharmaceutical Co., Ltd. have received Fast Track designation from the FDA for its investigational oral treatment for dry age-related macular degeneration, ACU-4429. After presenting successful Phase 1 data at several medical conferences in 2009, Acucela and Otsuka Pharmaceuticals launched the Evaluating a Novel VISION (ENVISION) treatment for AMD Clarity Trial, a Phase 2 clinical trial of ACU-4429 in patients with dry AMD in January 2010. ACU-4429 utilizes Acucela's proprietary visual cycle modulation (VCM) technology and is designed to prevent or inhibit the generation of toxic by-products of the visual cycle that can lead to degenerative eye conditions such as dry AMD. To find out more, click here. | ||
| HASSAN AND
SAUNDERS TAKE NEW ROLES AT BAUSCH + LOMB, RENU MULTIPLUS RECEIVES RECOGNITION IN HONG KONG. Bausch + Lomb stated in a recent press release
that in replacing Chairman and CEO Gerald M. Ostrov, who is retiring, it has named Fred Hassan
as chairman of the Board of Directors and Brent Saunders as chief executive officer and member
of the Board of Directors, effective immediately. Mr. Ostrov will serve as a consultant to Mr.
Hassan and Mr. Saunders. Mr. Hassan served most recently as chairman and CEO of Schering-Plough
Corporation until its merger with Merck & Co. in November 2009 and Mr. Saunders was previously
senior vice president and president of Schering&345;Plough's Consumer Healthcare unit.
In other company news, Bausch + Lomb ReNu MultiPlus multi-purpose solution has been named “Best Eye Care Product of the Year Asia” for its revolutionary bottle design at this year's A.S. Watson Global Suppliers Awards, Held in Hong Kong at the beginning of March. The awards recognize international brands for outstanding performance in bringing innovation, differentiation and excitement to the consumer experience. ReNu MultiPlus multi-purpose solution has a transparent bottle design, allowing consumers to examine the purity of the solution from outside and see how much is left with a “run out” indicator. |
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| SURMODICS, FORSIGHT LABS ENTER AGREEMENT TO LICENSE TECHNOLOGY. SurModics, Inc. issued a press release stating that it has entered into an agreement with ForSight Labs, LLC to license certain non-core ophthalmology technology. The technology licensed in this agreement does not include SurModics' I-vation drug delivery technology and while the license agreement contains an up-front license fee, milestone payments and royalties, specific terms of the agreement were not disclosed. | ||
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