A weekly e-journal by Art Epstein, OD, FAAO


Volume 11, Number 13

Monday, March 28, 2011


In this issue: (click heading to view article)
######### Off the Cuff: Certain Uncertainty

######### Aspheric Wavefront-Guided LASIK to Treat Hyperopic Presbyopia: 12-Month Results with the VISX Platform
######### Inflammation Assessment After SLT Treatment
######### Reading Performance After Implantation of a Small-aperture Corneal Inlay for the Surgical Correction of Presbyopia: Two-year Follow-up
######### News & Notes

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Off the Cuff: Certain Uncertainty

Every now and then, no matter where I am, when a day is particularly nice, a day sunny and warm like the summer days when I was a kid growing up in the Bronx, my memory drifts back. I often think of one day in particular. The Fourth of July when I was 8.

That day stands out because it was perfect. My family spent that entire day together from breakfast to lighting off the last of the fireworks, late into a glorious evening. As I recall that day, it unfolds into moments so perfect that only I, having been there, could possibly appreciate them.

Five decades later, I understand that what made that day so perfect was its certainty—the certainty of my parents always being there, my brother always beside me and kind neighbors who were friends. As a kid, I always had the certainty of love.

Today's headlines punctuate the perfection of that day. As certain as our lives were back in those perfect days of summer, they are as uncertain today. Earthquakes, tsunamis, radiation leaks, upheaval in the Middle East; each bring misery and uncertainty.

Even in our small eye world, upheaval resounds. Too many schools, too much debt, contentious attempts at board certification, access issues. It seems so overwhelming sometimes. Then I realize that despite it all, I am still here with you and doing well. I know the summer isn't far off and that somewhere, a kid will be spending the Fourth of July with his family and that day will be perfect.


Arthur B. Epstein, OD, FAAO
Chief Medical Editor


Want to share your perspective? Write to Dr. Epstein at artepstein@optometricphysician.com. Comments received may be published on OP-Blog at the discretion of the editor without attribution. Please indicate if you would like your thoughts attributed to you.

The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of the editorial board, Jobson Publishing or any other entities or individuals.


Aspheric Wavefront-Guided LASIK to Treat Hyperopic Presbyopia: 12-Month Results with the VISX Platform
A prospective, non-randomized, clinical trial of 66 eyes of 33 hyperopic patients who underwent customized bilateral refractive surgery, which included an aspheric presbyopia treatment shape and wavefront-driven hyperopic treatment, was studied to evaluate an aspheric ablation profile to improve near vision in presbyopic patients with hyperopia and to outline the key factors of success. Surgeries were performed using the VISX STAR S4 or STAR S4 IR excimer laser system (Abbott Medical Optics). Mean preoperative refractive error was +1.77 ± 0.56 D sphere (range: 0.75 to 3.50 D) with 0.41 ± 0.34 D cylinder (range: 0.00 to 1.50 D). All patients received full distance refractive correction. No patients received monovision or were intentionally left with residual myopia. Patient satisfaction results were evaluated using a questionnaire with a 5-point scale.

A total of 60 eyes completed 6-month and 50 eyes completed 12-month postoperative follow-up. At 6 months, mean corrected distance visual acuity (CDVA) was 20/20 ± 1 line (range: 20/25 to 20/10). Mean gain in distance-corrected near visual acuity (DCNVA) was 2.7 ± 1.7 lines with a maximum of 6 lines of near. Spectacle dependence for tasks, such as reading and computer use, was reduced. At 12 months, 100% of patients had achieved binocular simultaneous uncorrected vision of 20/25 or better and J3. Refraction was stable over 12 months. Contrast sensitivity reduction was clinically insignificant. Negative spherical aberration highly correlated with postoperative improvement of DCNVA. Patients who had a larger amount of preoperative hyperopia or a greater decrease of preoperative DCNVA were more likely to have overall satisfaction.

The aspheric ablation designed to expand near functional vision was effective and stable over 12 months. The wavefront-customized hyperopic treatment significantly reduced spectacle dependence.

SOURCE: Jackson WB, Tuan KM, Mintsioulis G. Aspheric wavefront-guided LASIK to treat hyperopic presbyopia: 12-month results with the VISX platform. J Refract Surg. 2010; Nov 15:1-11.

Inflammation Assessment After SLT Treatment
Selective laser trabeculoplasty (SLT) appears to be a safe and effective method to lower intraocular pressure (IOP). The exact mechanism of action for reducing IOP and inflammation levels is not known. The aim of this study was to assess inflammation after SLT treatment. Forty patients (80 eyes) were included in the study. Inclusion criteria included glaucoma (pigmentary and pseudoexfoliative glaucoma)/ocular hypertension patients treated with SLT in just one eye, both with and without eye-drops. Exclusion criteria included patients suffering from ocular or systemic inflammatory diseases treated with cortisone or immunosuppressive drugs. Inflammation was measured in two different ways: (i) clinically with a slit lamp and classified 0–4; (ii) objectively with a ‘Laser flare meter (Kowa FM 500)’. Measurements were taken before SLT, 2-hr, 1-week and 1-month after SLT treatment, both eyes were evaluated. IOP was also checked in the same way. SLT treatment was performed in 90°.

Inflammation before and after SLT showed no significant difference measured clinically with slit lamp and objectively with the laser flare meter among the groups. No inflammation or IOP reduction was found in the untreated eyes. No IOP spikes after SLT treatment were found.

Selective laser trabeculoplasty treatment seems not to induce inflammation in the anterior chamber when 90° was treated. SLT effectively and safely lowers IOP and might be considered as primary therapy.

SOURCE: Ayala M, Landau Högbeck I, Chen E. Inflammation assessment after selective laser trabeculoplasty (SLT) treatment.Acta Ophthalmol. 2011; Mar 22 [Epub ahead of print].

Reading Performance After Implantation of a Small-aperture Corneal Inlay for the Surgical Correction of Presbyopia: Two-year Follow-up
This study evaluated the change in reading-performance parameters after implantation of the Kamra small-aperture intracorneal inlay over a 2-year follow up. Study subjects comprised naturally emmetropic presbyopic patients. Bilateral reading acuity, reading distance, reading speed, and the smallest log-scaled sentence were evaluated in a standardized testing procedure using the Salzburg Reading Desk. The minimum postoperative follow up was 24 months.

The study enrolled 32 patients. The reading desk results showed a significant improvement in each parameter tested. After a mean follow up of 24.2 months ± 0.8 (SD), the mean reading distance changed from the preoperative value of 48.1 ± 5.5 cm to 38.9 ± 6.3 cm, the mean reading acuity at best distance improved from 0.3 ± 0.14 logRAD to 0.24 ± 0.11 logRAD, and the mean reading speed increased from 142 ± 13 words per minute (wpm) to 149 ± 17 wpm. One patient lost 1 line, and 1 patient had no change. The improvement was up to 6 log-scaled lines (mean improvement 2.7 ± 1.6 lines) in the other 30 patients.

After implantation of the small-aperture intracorneal inlay, there was an improvement in all tested reading performance parameters in emmetropic presbyopic patients; the improvement was the result of an increased depth of field. These 2-year results indicate that the inlay is an effective treatment for presbyopia.

SOURCE: Dexl AK, Seyeddain O, Riha W, et al. Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: Two-year follow-up. J Cataract Refract Surg. 2011;37(3):525–531.


News & Notes
WITH POSITIVE PHASE 2 RESULTS OF PF-04523655 FOR DME, QUARK AIMS TO INITIATE PHASE 2B STUDY. Quark Pharmaceuticals, Inc. has received results from a prospective, randomized Phase 2 trial, the DEGAS study, which evaluated the safety and efficacy of PF=04523655 (RTP801I-14) in patients with diabetic macular edema (DME). The study was designed with a primary endpoint of mean visual acuity improvements over baseline at 24 months and 184 patients were randomly assigned to four treatment groups; three dose levels of PF-04523655 (RTP801I-14) (0.4 mg, 1 mg and 3mg) or laser. Interim results at 12 months showed that there were no drug-related Serious Adverse Events (SAEs) and following 12 months of treatment with PF-04523655 (RTP801I-14), a dose-dependent improvement in visual acuity was observed with the best results achieved at the 3-mg dose level. The study was terminated at 12 months based upon the interim analysis suggesting that higher doses would be necessary to produce a therapeutic effect sufficiently superior to the current standard of care to benefit patients over the long term, given emerging new therapeutic modalities. Based on these results, and in view of a dose-related effect on vision, Quark and Pfizer have mutually agreed that a Phase 2b study will be conducted by Quark at its own expense under a protocol mutually agreed upon by Quark and Pfizer, where Quark will test higher doses of PF-04523655 (RTP801I-14) and determine the optimal dose for pivotal Phase 3 studies. The two companies have also agreed to amend their existing agreement to enable Quark to conduct the Phase 2b study. For more information, visit www.quarkpharma.com.
R-TECH UENO AND SUCAMPO ENTER LICENSE AGREEMENT FOR UNOPROSTONE. After the termination of a license agreement with Novartis Pharma AG last year, R-Tech Ueno, Ltd. sought a new licensee to maximize business profit from unoprostone (Rescula), and has recently signed a new license agreement with Sucampo Manufacturing and Research AG (SMR), a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. Under the terms of the agreement, SMR holds exclusive rights to develop, use, make, have made, export, commercialize, promote, offer for sale and sell unoprostone in SMR Territory for its approved indication, the treatment of glaucoma and ocular hypertension. Also under this agreement, SMR has gained the right to develop the drug for additional ophthalmic indications as well as rights to all associated patents and other intellectual property associated with unoprostone in SMR territory. R-Tech Ueno receives an upfront payment of $3 million from SMR upon execution of the agreement and will receive additional milestone payments based on the achievement of specified development and commercialization goals. Read more here.
OCUSOFT INTRODUCES OCUDOX CONVENIENCE KIT. OCuSOFT, Inc. has announced the introduction of prescription-only Ocudox Convenience Kit, which contains Ocudox (doxycycline hyclate 50 mg, 60 capsules, USP), OCuSOFT Lid Scrub PLUS Extra Strength Pre-Moistened Pads (30 ct) and Tears Again advanced Liposome Spray (15 mL). According to the company, each component in the Ocudox Convenience Kit was carefully selected as a result of requests from doctors seeking a simple yet effective treatment option specific to acute cases of lid disease. Learn more at www.ocudox.com.
BALL AND ROUTHIER TAKE ON NEW ROLES AT VISTAKON, NEW PROGRAM UNVEILED AT THE VISION CARE INSTITUTE. Vistakon, Division of Johnson & Johnson Vision Care, Inc., has named W. Lee Ball, OD, FAAO, Associate Director and Janelle Routhier, OD, FAAO, Manager, Medical Affairs. For the past year, Dr. Ball has served as part of the company's Professional Affairs Consultant team. In his new role, he will be responsible for providing strategic direction and leadership for Medical Affairs. Dr. Routhier brings practice-based clinical optometric and academic optometric education experience to her new position and recently focused on complex specialty contact lens fitting and soft as well as RGP custom lens design. She will now be responsible for clinical and technical aspects of Acuvue Brand Contact Lenses. Both Drs. Ball and Routhier will report to Sheila Hickson-Curran, BSc, MCOptom, Director, Medical Affairs.

In other Vistakon news, The Vision Care Institute, LLC has launched a new educational program for practicing optometrists. The one-day course, held at The Vision Care Institute headquarters in Jacksonville, Floriday, covers an update on the latest in contact lens research, training on new technologies, as well as a review of emerging trends and best practices and is designed to help optometrists achieve higher levels of success in their practices. The course is available at no cost. Upcoming course dates include May 12-13, May 19-20, June 2-3, June 9-10 and September 22-23. Contact your Vistakon sales rep or e-mail theinstitute@vcius.jnj.com for more information or to register.



Optometric Physician™ Editorial Board

Chief Medical Editor
Arthur B. Epstein, OD, FAAO

Journal Reviews
Shannon Steinhäuser, OD, FAAO

Karen Rodemich

Art/Production Director
Joe Morris

Contributing Editors
• Katherine M. Mastrota, MS, OD, FAAO
• Michael Mayers, OD, FAAO
• Barry A. Weissman, OD, PhD, FAAO (Dip CL)

Editorial Board
• William Jones, OD, FAAO
• Alan G. Kabat, OD, FAAO
• Bruce Onofrey, RPh, OD, FAAO
• John Schachet, OD, FIOS
• Joseph Shovlin, OD, FAAO



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