Off the Cuff: A Time for Healing...

The past few months have been a challenge for our profession, our patients, and especially for the contact lens and lens care industry. We have experienced more recalls, more uncertainty and more negative publicity in the recent past than in our profession’s entire history. Optometry, the AOA, AAO and most notably the AOA Contact Lens and Cornea Section have risen to the challenge. Sadly, the impact on our patients and our practices lingers.

While some haven’t noticed the rancorous undercurrent, more and more of my friends are expressing concern. At some meetings you can actually feel the tension and frustration. It’s easy to understand why. When patients and practice are imperiled, blame spreads like ripples in a pond. What was once competitive but collegial has turned ugly; lately, both companies and colleagues have been butting heads.

No one would argue that what happened was intentional. The products recalled were designed to make patients’ lives better, not to harm them. Could we have done things better? Perhaps, but hindsight is always 20/20.

For the contact lens industry to recover, we need to work together. We need to glean what we can from these experiences and make contact lens wear safer. Key opinion leaders and companies need to put rivalries aside and help restore industry cohesion, public confidence and forward momentum. All of us need to keep in mind that an industry that has supported our professional advancement is now struggling to recover from a calamity that no one could have anticipated and certainly no one deserved. Be kind out there.

Arthur B. Epstein, OD, FAAO Chief Medical Editor artepstein@optometricphysician.com

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.

Sleep-related disorders are among the important risk factors for neurovascular diseases. Obstructive sleep apnea syndrome (OSAS) is characterized by snoring, excessive daytime sleepiness and insomnia. This study’s aim was to investigate the presence of glaucoma in patients with OSAS and to reveal vascular pathology related to the pathogenesis of glaucoma in those patients.

The study included 31 patients with OSAS and 25 control subjects. Orbital Doppler ultrasonography was used to determine the resistivity index in the ophthalmic artery and central retinal artery. All patients and controls underwent perimetric examination.

The prevalence of glaucoma in patients with OSAS was 12.9 percent (four of 31 patients); all of these patients were in the "severe" OSAS group. No statistically significant difference was found between ophthalmic artery resistivity index (OARI), central retinal artery resistivity index (CRARI) and intraocular pressure (IOP) between patients and controls. A positive correlation emerged between OARI and mean defect, CRARI and mean defect and CRARI and loss variance values. There was also a positive correlation between IOP and the apnea-hypopnea index.

In patients with OSAS, a high prevalence of glaucoma was found. It is interesting to note that all four glaucoma patients in this study had severe OSAS. The positive correlation observed between IOP and the apnea-hypopnea index suggests that increased IOP values may reflect the severity of OSAS. The positive correlation between OARI and mean defect and also between CRARI and mean defect as well as loss variance suggests that visual field defects may be due to optic nerve perfusion defects. These field defects also increase as the resistivity index increases.

SOURCE: Karakucuk S, Goktas S, Aksu M, et al. Ocular blood flow in patients with obstructive sleep apnea syndrome (OSAS). Graefe's Arch Clin Exp Ophthalmol 2007; Aug 4 [Epub ahead of print].

Twenty eyes of 20 patients with retinal vein occlusion were evaluated to study the pathomorphologic features of cystoid macular edema (CME) by three-dimensional (3D) optical coherence tomography (OCT) and to study the relationship of the ocular findings to visual function. A prototype 3D OCT system based on Fourier-domain technology was fabricated for patient examination in this study. This system uses a superluminescent diode, which has a center wavelength of 830 nm and a bandwidth of 50 nm as the light source, resulting in 4.3-micron axial resolution in tissue. Data acquisition rates of approximately 18,700 axial scans per second and a sensitivity of 98 dB were achieved. 3D imaging was performed by volume rendering based on the 3D data set acquired with a raster scan of 256 x 256 axial scans. Images of CME pathologic features obtained by 3D OCT and by Stratus OCT.

The 3D OCT imaging system generates a realistic 3D image of CME with high resolution. In 16 eyes, 3D OCT showed large foveal cystoid spaces, most of which were accompanied by small cystoid spaces in the parafoveal region. Cystoid spaces were seen often in the inner nuclear layer and outer plexiform layer but were detected to some extent in all retinal layers. The 3D OCT showed clearly a thin back-reflecting line corresponding to the external limiting membrane (ELM) in 18 eyes; of these, cystoid spaces were located on the inside of the ELM in seven eyes and appeared to be in contact with the ELM in nine eyes. In two eyes, the ELM line could not be seen clearly beneath the large foveal cystoid spaces. Integrity of the ELM in the foveal region had a direct correlation with visual acuity.

Observation of CME using 3D OCT enabled visualization of its spatial extent in each retinal layer and discernment of its relationship to the ELM. The use of 3D OCT thus may improve the monitoring of CME progression and its response to treatment.

SOURCE: Yamaike N, Tsujikawa A, Ota M, et al. Three-dimensional imaging of cystoid macular edema in retinal vein occlusion. Ophthalmol 2007; Aug 1 [Epub ahead of print].

Prognosis of Penetrating Injuries with Intraocular Foreign Body

The records of 28 eyes of 27 patients who underwent pars plana vitrectomy and intraocular foreign body removal during a five-year period were retrospectively reviewed to identify the prognostic factors concerning the anatomy and visual acuity of eyes subject to trauma-related posterior intraocular foreign body. Ocular trauma score was calculated for each eye.

The most common initial findings were corneal wound (68 percent), lens injury (50 percent), retinal lesion (50 percent), vitreous hemorrhage (25 percent) and endophthalmitis (14 percent). Multiple foreign body causing perforating injury with retained posterior segment foreign body occurred in 7 percent of the cases. The foreign body was found on the surface of the retina in 39 percent of the cases. Postoperative complications were: retinal detachment (46 percent), proliferative vitreoretinopathy (25 percent) and phthisis (4 percent). No eye was enucleated and one eye (4 percent) lost light perception. The final best-corrected visual acuity became better or equal to 0.5 Snellen E in 34 percent of the eyes.

Prognosis was significantly worse in cases with lower trauma score, initial visual acuity less than 0.1 Snellen E, large foreign body, onset of bacterial endophthalmitis or proliferative vitreoretinopathy. Visual outcomes in these cases were better than estimated based on ocular trauma score parameters.

SOURCE: Szijarto Z, Gaal V, Kovacs B, Kuhn F. Prognosis of penetrating eye injuries with posterior segment intraocular foreign body. Graefe's Arch Clin Exp Ophthalmol 2007; Aug 4 [Epub ahead of print].

Twelve-Month Safety of Intravitreal Injections of Bevacizumab

Vascular endothelial growth factor (VEGF) plays an important role in many diseases of the posterior pole that are characterized by macular edema and/or intraocular neovascularization. Recently, anti-VEGF agents such as ranibizumab and pegaptanib sodium have been proved beneficial in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). However in most parts of the world, both pegaptanib sodium and ranibizumab are not readily available. Bevacizumab, a humanized recombinant monoclonal IgG antibody that binds and inhibits all VEGF isoforms, has been proposed as an alternative treatment option.

A total of 1,265 consecutive patients were injected with bevacizumab for diseases such as proliferative diabetic retinopathy, diabetic macular edema, retinal vein occlusions and CNV of several etiologies including AMD at eight Latin American institutions from September 1, 2005 to January 31, 2006. Of these patients, 92 were excluded because they were injected once and lost to follow-up. The remaining 1,173 patients constitute the subjects of this retrospective, multicenter, open label, uncontrolled interventional case series that reports the cumulative systemic and ocular adverse events following intravitreal bevacizumab during 12 months of follow-up.

Patients were examined at baseline and then monthly. If the patients were unable to attend the 12-month visit, a telephone interview was conducted to assess for possible systemic complications. A total of 4,303 intravitreal injections of bevacizumab on 1,310 eyes was reported. All 1,173 patients were accounted for at the 12-month visit. Systemic adverse events were reported in 18 (1.5 percent) patients. These included seven cases of an acute elevation of systemic blood pressure (0.59 percent), six cerebrovascular accidents (0.5 percent), five myocardial infarctions (0.4 percent), two iliac artery aneurysms (0.17 percent), two toe amputations (0.17 percent) and five deaths (0.4 percent). Ocular complications included seven cases of bacterial endophthalmitis (0.16 percent), seven tractional retinal detachments (0.16 percent), four cases of uveitis (0.09 percent), and one case (0.02 percent) each of rhegmatogenous retinal detachment and vitreous hemorrhage.

Despite the limited follow-up, repeated intravitreal injections of either 1.25 mg or 2.5 mg of bevacizumab appears to be safe and well tolerated during the first year.

SOURCE: Wu L, Martinez-Castellanos MA, Quiroz-Mercado H, et al. Twelve-month safety of intravitreal injections of bevacizumab (Avastin): Results of the Pan-American Collaborative Retina Study Group (PACORES). Graefe's Arch Clin Exp Ophthalmol 2007; Aug 3 [Epub ahead of print].

NEWS & NOTES

	ACUVUE CONTACT LENS BRANDS EARN WCO GLOBAL SEAL OF ACCEPTANCE. Three Johnson & Johnson Vision Care products, Acuvue Advance with Hydraclear, Acuvue Advance for Astigmatism, and Acuvue Oasys with Hydraclear Plus contact lenses, are the first to receive the World Council of Optometry’s (WCO) Global Seal of Acceptance for Ultraviolet Absorbing Contact Lenses. The lens brands meet established, recognized and accepted standards that are adopted by the WCO Global Commission on Ophthalmic Standards (GCOS), according to WCO President Robert Chappell. These include published standards of International Standards Organization (ISO) and American National Standards Institute (ANSI). ISO and ANSI standards classify UV-blocking contact lenses into two groups based on the lens’ absorptive capacity at its minimum thickness: Class 1 UV-blockers must absorb a minimum of 90 percent UVA and at least 99 percent UVB radiation; Class 2 UV-blockers must absorb at least 70 percent of UVA and more than 95 percent of UVB radiation. Only products that meet these standards may claim to be UV-blocking. All three Acuvue brand lenses previously received the AOA Seal of Acceptance for Ultraviolet Absorbers/Blockers.
	BAYER AND REGENERON LAUNCH PHASE III STUDY OF VEGF TRAP-EYE FOR WET AMD. Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. have initiated a Phase III study of the VEGF Trap-Eye for the neovascular (“wet”) form of age-related macular degeneration (AMD). The study is a non-inferiority comparison of the VEGF Trap-Eye and ranibizumab (Lucentis, a registered trademark of Genentech), an anti-angiogenic agent approved for use in wet AMD; it will be conducted pursuant to a Special Protocol Assessment from the FDA. Known as VIEW 1 (VEGF Trap: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration), the randomized, double-masked study is expected to enroll approximately 1,200 patients in more than 200 centers throughout the United States and Canada. It will evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 mg and 2.0 mg administered at four-week dosing intervals, and 2.0 mg at an eight-week dosing interval, compared to 0.5 mg of ranibizumab administered every four weeks, consistent with its labeled dosing schedule. The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year, compared to ranibizumab patients. After the first year of treatment, patients will continue to be treated and followed for another year. Bayer HealthCare will market the VEGF Trap-Eye outside the United States, where the parties will share equally in profits from any future sales of the product. Regeneron maintains exclusive rights to the VEGF Trap-Eye in the United States. For more information, go to www.regeneron.com or www.bayerhealthcare.com.
	CYNACON/OCUSOFT LAUNCHES ADJUNCTIVE EYELID THERAPY AND HYGIENE PRODUCT. Cynacon/Ocusoft has announced the launch of prescription-only Alodox Convenience Kit for adjunctive eyelid therapy and hygiene. The kit contains Alodox (doxycycline hyclate 20 mg), Ocusoft Lid Scrub Plus Extra Strength Pre-Moistened Pads and Ocusoft Lid Scrub Original Foaming Eyelid Cleanser. The pre-moistened pads provide an extra-strength eyelid cleanser that uses a low-level preservative and moisturizer blend, with wide range of anti-bacterial properties for moderate-to-severe eyelid conditions. The Original Foaming Eyelid Cleanser is an instant foam liquid that produces pre-lathered foam from a pump dispenser, for added convenience of patients on a lid-hygiene regimen. The use of low-dose doxycycline hyclate has demonstrated effective enzyme modulation treatment of inflammatory disease, and at a low-level dose of 50 mg or less, it reduces inflammation but maintains maximum plasma drug concentrations below the anti-microbial threshold. For more information about the kit, go to www.alodox.com. For more about Ocusoft's other products, go to www.ocusoft.com.