Volume 12, Number 17
Monday, April 23, 2012

In this issue: (click heading to view article)
######### From the Editor: The Future of Medicine

######### Intravitreal Bevacizumab vs Laser Therapy in the Management of DME

######### Retinal Detachment Following Phakic IOL Implantation in Severe Myopic Eyes
######### Link Between Sustained Increased IOP and Intravitreal Anti–VEGF for Neovascular AMD
######### Comparison of Pain Scores With and Without Use of Supplementary 2% Lidocaine Gel in LASIK
######### Briefly


From the Editor: The Future of Medicine

I have seen so many changes in my career that some days I go home talking to myself. Understandably, many of these changes have been very positive for both my patients and myself, as ophthalmology has witnessed truly miraculous advances in the past decades. However, all too many changes have been a burden, and in that regard, I feel we are to enter a whole new period of disruption. We now hear of the unthinkable as medical practices near bankruptcy and how young physicians feel their future is not a bright as that of their predecessors. Not the environment one wants to be in, given the mental and physical demands of the job, let alone the liability.

Constant battles with insurance companies over pharmaceutical approvals and surgical precertifications, along with an ever-increasing burden of regulation, oversight and so on and so forth have complicated an already demanding job. Over the next decade, as baby-boomers age and consume greater healthcare dollars, I fear we, as physicians, will be put in the middle as the messengers of news patients may not like to hear. This information will not be about a serious diagnosis, but more so about what their insurance company or the government has determined they are due in terms of care.

Additionally, significant costs will be placed upon practices to provide information technology upgrades and additions for the purposes of the monitoring of care and increasing efficiency all at the same time that reimbursements are threatened. Sounds like loads of fun.

Organized medicine needs to become more organized. We need to fashion a very clear message in terms of where we are willing to work with the system to benefit our patients and where we will not go. We must not forget why we chose our profession and must defend its nobility. I strongly believe that once the right folks realize they pushed the docs too far, meaningful changes will occur, but not one second before.

Stephen Pascucci, MD, FACS

Intravitreal Bevacizumab vs Laser Therapy in the Management of DME

In this 2-year, single-center, randomized controlled trial, investigators randomized 80 patients with center-involving clinically significant macular edema (CSME) and visual acuity of 20/40 to 20/320 to receive either bevacizumab or macular laser therapy (MLT). The purpose of the study was to report the 2-year outcomes of the BOLT study, a prospective randomized controlled trial evaluating intravitreous bevacizumab and modified Early Treatment Diabetic Retinopathy Study (ETDRS) MLT in patients with persistent CSME.

Primary outcome was the difference in ETDRS best-corrected visual acuity (BCVA) between arms. Secondary outcomes were the mean change in BCVA, proportion gaining at least 15 and at least 10 ETDRS letters, losing fewer than 15 and at least 30 letters, change in central macular thickness, ETDRS retinopathy severity, and safety outcomes.

The study investigators reported that at 2 years, mean (SD) ETDRS BCVA was 64.4 (13.3) (ETDRS equivalent Snellen fraction: 20/50) in the bevacizumab arm and 54.8 (12.6) (20/80) in the MLT arm (p = .005). They also noted that the bevacizumab arm gained a median of 9 ETDRS letters vs 2.5 letters for MLT (p = .005), with a mean gain of 8.6 letters for bevacizumab vs a mean loss of 0.5 letters for MLT. A total of 49% of patients gained 10 or more letters (p = .001) and 32% gained at least 15 letters (p = .004) for bevacizumab vs 7% and 4% for MLT. Percentage who lost fewer than 15 letters in the MLT arm was 86% vs 100% for bevacizumab (p = .03). Mean reduction in central macular thickness was 146 µm in the bevacizumab arm vs 118 µm in the MLT arm. The median number of treatments over 24 months was 13 for bevacizumab and 4 for MLT.

This study provides evidence supporting longer-term use of intravitreous bevacizumab for persistent center-involving CSME.

SOURCE: Rajendram R, Fraser-Bell S, Kaines A, et al. A 2-year prospective randomized controlled trial of intravitreal Bevacizumab Or Laser Therapy (BOLT) in the management of diabetic macular edema. Apr 9 [Epub ahead of print].


Retinal Detachment Following Phakic IOL Implantation in Severe Myopic Eyes

The authors of this Chinese retrospective interventional non-comparative case series reported the incidence, clinical presentation and surgical outcomes of retinal detachment in highly myopic patients corrected by implantation of phakic intraocular lenses (PIOLs).

They included 530 highly myopic eyes that underwent PIOLs implantation. All patients completed at least a 2-year follow-up after PIOL implantation. The authors reviewed the incidence of retinal detachment (RD) and subsequent treatments and also analyzed the refractive errors, axial lengths, time between refractive surgery and RD detection, vitreoretinal findings, rate of retinal reattachment, and the pre- and postoperative best-corrected visual acuity (BCVA).

According to the authors, the overall incidence of RD was 1.5% (eight eyes of seven patients) with a mean time between PIOL implantation and detachment of 23.63 ± 18.12 months (range, 2 days–51 months). They found that mean spherical equivalent (SE) before PIOL implantation was –17.53 ± 3.86 diopters (D) (range, –11.5D to –23.5D). Six patients underwent bilateral PIOL implantation. Five eyes were implanted with anterior chamber PIOLs and the other three received posterior chamber PIOLs. A traumatic history was presented before RD detection in four cases and the study authors found Horseshoe tears, atrophic holes or giant retinal tears in four (50%), two (25%) and two (25%) eyes, respectively. The authors reported that two eyes (25%) underwent scleral buckling surgery, five eyes (62.5%) underwent pars plana vitrectomy surgery and one eye (12.5%) underwent both procedures. They also noted that anatomical retinal attachment was achieved after first RD surgery in seven eyes and that mean BCVA after PIOL implantation and before RD was 20/40 (decimal refraction, 0.51 ± 0.31) compared to that of 20/80 (decimal refraction, 0.26 ± 0.12) after the RD surgery. Moreover, mean follow-up after RD surgery was 20.63 ± 12.93 months (range, 8–42 months).

In conclusion, the incidence of RD after PIOLs implantation is low. Its characteristics do not differ significantly from the natural history of RD in high myopic eyes. PIOL implantation for surgical correction of severe myopia does not seem to increase the risk of RD. Good visual prognosis can be obtained with early surgical intervention.

SOURCE: Jiang T, Chang Q, Wang X, Huang X. Retinal detachment after phakic intraocular lens implantation in severe myopic eyes. Graefes Arch Clin Exp Ophthalmol. 2012; Apr 4. [Epub ahead of print].

Link Between Sustained Increased IOP and Intravitreal Anti-VEGF for Neovascular AMD

To describe a series of previously normotensive eyes experiencing sustained elevated intraocular pressure (IOP) associated with long-term intravitreal antivascular endothelial growth factor (VEGF) therapy for neovascular age-related macular degeneration (AMD), clinical data were reviewed for 25 eyes of 23 patients with neovascular AMD who had increased IOP while receiving interval doses of intravitreal ranibizumab and/or bevacizumab. All eyes had tolerated multiple anti-VEGF injections in the past without IOP elevations.

After a mean of 20.0 anti-VEGF injections (range, 8–40 injections), the mean IOP was 29.8 mm Hg (range, 22–58 mm Hg), compared with a baseline of 16.9 mm Hg (range, 14–21 mm Hg). The mean highest IOP while receiving intravitreal anti-VEGF therapy was 35.8 mm Hg (range, 23–58 mm Hg). Overall, 23 of 25 cases required IOP management. In the remaining 2 cases, anti-VEGF dosing was switched from regular interval dosing to an optical coherence tomography-guided variable regimen, with subsequent improvement in IOP without anti-glaucoma treatment.

Serial injections of anti-VEGF agents may lead to persistent IOP elevations that require glaucoma therapy. The clinician should recognize this phenomenon, as it can occur even if the patient has tolerated multiple prior injections without IOP elevation. Further exploration of the relationship between anti-VEGF therapy and IOP is needed.

SOURCE: Tseng JJ, Vance SK, Della Torre K, et al. Sustained increased intraocular pressure related to intravitreal antivascular endothelial growth factor therapy for neovascular age-related macular degeneration. J Glaucoma. 2012;21(4):241–247.


Comparison of Pain Scores With and Without Use of Supplementary 2% Lidocaine Gel in LASIK

Researchers in China compared pain scores with and without supplementary topical 2% lidocaine gel in patients undergoing simultaneous bilateral laser-assisted in situ keratomileusis (LASIK) under topical anesthesia using 0.5% proparacaine eye drops in this randomized double-masked placebo-controlled trial.

They included 51 Chinese subjects (102 eyes, with 51 eyes in each arm) and randomly allocated one eye to have supplementary 2% lidocaine gel while the other eye received carbomer gel as control, in addition to topical 0.5% proparacaine. The researchers assessed pain scores for each eye during microkeratome flap creation, during laser ablation, and at 15, 30 and 45 minutes after LASIK. They also obtained an overall pain score of the LASIK procedure. Primary outcome measures were pain scores during and after LASIK. Secondary outcomes included need for additional topical anesthesia, patient cooperation score, and duration and complications of surgery.

The study researchers observed that in the 2% lidocaine gel–treated group, the pain scores were significantly lower during microkeratome flap creation and laser ablation, and postoperatively at 30 and 45 minutes (p < .05 for all). They also determined that patients in the lidocaine gel group required less additional topical anesthesia (p = .0004) and were more cooperative (p = .019) as compared to the carbomer gel group. They observed no surgical or postoperative complications.

To conclude, the use of supplementary 2% lidocaine gel in LASIK is effective in lowering the pain experienced during and up to 45 minutes after LASIK.

SOURCE: Lam DS, Law RW, Ng AS, et al. Randomized double-masked controlled trial comparing pain scores with and without use of supplementary 2% lidocaine gel in LASIK. Am J Ophthalmol. 2012;153(4):627–631.

  • ABBOTT RECEIVES CLEARANCE FOR iFS ADVANCED FEMTOSECOND LASER TECHNOLOGY. The FDA has issued clearance to Abbott to use its iFS Advanced Femtosecond Laser to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery. The laser is currently used to create LASIK flaps and other corneal incisions in the eye. More information is available at www.abbott.com.
  • THROMBOGENICS RESUBMITS BLA FOR OCRIPLASMIN. In a recent press release, ThromboGenics reported that it has resubmitted a Biologics License Application (BLA) with the FDA for ocriplasmin intravitreal injection, 2.5 mg/ml, for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole. In February 2012, the FDA indicated that it intended to assign a Priority Review designation to the original BLA submission for the same indication filed in December 2011. ThromboGenics says that its recent re-submission will allow it to meet the FDA's Priority Review timelines and manage the phasing of its resources to support both its European and U.S. ocriplasmin filings. The European Medicines Agency is currently reviewing ThromboGenics' Marketing Authorisation Application for ocriplasmin for the same indication.
  • FDA APPROVES TWO CLEAR OPTIC IOLS FROM HOYA. HOYA Surgical Optics, Inc. has received approval from the FDA to commercially distribute two models of clear foldable hydrophobic acrylic-optic aspheric intraocular lenses, the iSymm Intraocular Lens and the preloaded iSert Intraocular Lens, in the United States. Visit the company's website for more information.
  • NEW DRY EYE THERAPY AVAILABLE FROM OCUSOFT. OCuSOFT, Inc. is offering a new therapy for individuals suffering from dry eye syndrome and meibomian gland dysfunction: Retaine MGD Ophthalmic Emulsion. A preservative-free, oil-in-water emulsion that moisturizes, lubricates and protects moderate to severe dry eyes, the product is packaged in 30 single-dose vials. Utilizing a proprietary cationic process of binding positively charged ions to the negatively charged ocular surface, Retaine MGD prolongs corneal contact time, resulting in enhanced comfort. Learn more at www.ocusoft.com.
  • METLIFE TO OFFER NEW NATIONAL VISION PRODUCT. MetLife recently announced its new MetLife Vision PPO product as a complement to its other workplace products. The plan is available to employers in all 50 states with 10 or more eligible employees, subject to regulatory approval in certain states. According to MetLife, it offers flexibility for employers to select from a wide range of plan designs to best fit their needs, convenience and choice for members, industry-leading standard features as well as employee decision support tools and wellness programs, and ease of administration. Click here to find out more.
  • HARRY WILLIAM HIND, 1915–2012. Famed pharmacist, inventor and entrepreneur Harry William Hind died on April 12, 2012 at the age of 96. In 1939, he co-founded the Barnes-Hind Prescription Pharmacy with Clifford Barnes, initially filling only ophthalmic prescriptions, and Barnes-Hind Pharmaceutical Laboratories, both located in San Francisco. In 1940, Hind began his pioneering work with contact lenses, creating a buffering eye solution that absorbed the accumulation of carbon dioxide under all-plastic scleral contact lenses. He continued his research and eventually developed a line of contact lens cleaning and storage solutions that maintained the hydration of plastic lenses.

    In addition to the Ebert Prize in 1948, Hind's awards include: the Eye Research Foundation Award (1958); Distinguished Alumnus Award, UCSF Pharmacy Alumni Association (1966); the Helmholtz Ophthalmological Award, Western Section, Association for Research and Vision in Ophthalmology (1968); Carbert Award: Sight Conservation Research Association (1973); Distinguished Service Award, Proctor Foundation (1985); Contact Lens Person of the Year, American Optometric Association (1987); Man of the Year Award, Pharmacists Planning Service, Inc. (1987); Hall of Fame Award, Contact Lens Society of America (1989); and Honorary Recognition, Contact Lens Manufacturers Association, (1990).


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