Volume 6, Number 27
Monday, July 10, 2006



In this issue: (click heading to view article)
Lesion Morphology in AMD
Clinical Experience with Fuchs’ Corneal Endothelial Dystrophy Leading to PK
Accuracy of Self-Reporting of Medication Regimen in Glaucoma Patients
Family History of IBD in Patients with Idiopathic Ocular Inflammation
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Lesion Morphology in AMD

The Eye and Vision Research Institute, Sydney, Australia, retrospectively reviewed 3,580 consecutive cases of neovascular age-related macular degeneration (AMD) in an effort to quantify and categorize lesions of on the basis of fluorescein angiographic morphology.

Lesions were graded in terms of the location, size and composition, and categorized according to the lesion components. There were 2,642 subfoveal lesions (73.8 percent), 658 juxtafoveal lesions (18.4 percent) and 276 extrafoveal lesions (7.7 percent). After investigators excluded disciform lesions, they found that 1,337 subfoveal lesions (72.3 percent), 580 juxtafoveal lesions (88.1 percent) and 242 extrafoveal lesions (87.7 percent) consisted of at least 50 percent choroidal neovascularization. Most of this included a classic or an occult component, but not both. Subfoveal lesions (mean size, 2.82 Macular Photocoagulation Study disc areas) were significantly larger than juxtafoveal (mean size, 0.89 Macular Photocoagulation Study disc areas) or extrafoveal lesions (mean size, 1.04 Macular Photocoagulation Study disc areas), but overall the lesions were substantially smaller than those found in the major trials. It’s estimated that photodynamic therapy or photocoagulation may be offered to one-half to two-thirds of all patients with nondisciform neovascular AMD.

The authors concluded that the smaller lesion size and low proportion of mixed choroidal neovascularization lesions in their study suggest that treatment benefit and eligibility may be greater in the clinical setting than previously believed.

SOURCE: Beaumont PE, Kang HK. Lesion morphology in age-related macular degeneration and its therapeutic significance. Arch Ophthalmol 2006;124(6):807-12.
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Clinical Experience with Fuchs’ Corneal Endothelial Dystrophy Leading to PK

This study by Duke University Medical Center in Durham, NC, is a review of 30 years of clinical experience with Fuchs’ corneal endothelial dystrophy leading to penetrating keratoplasty (PK).

Investigators reviewed the clinical records of patients diagnosed histopathologically as having Fuchs’ corneal endothelial dystrophy who underwent PK at the university’s medical center between January 1, 1972, and December 31, 2001. The observational case series included 424 patients (546 eyes).

Women represented 77.6 percent of patients. Mean age at the time of PK for all patients was 69.2 years. Bilateral PK was required in 28.8 percent of patients, and the mean interval between the two PKs was 3.2 years. There was no gender difference in the likelihood of requiring bilateral PK. Among 376 documented family histories, 13.6 percent were known to be positive for Fuchs’ dystrophy. Patients with a positive family history underwent PK a mean of five years earlier than those without a positive history, and they were more likely to require bilateral PK. Patients who underwent bilateral PK were twice as likely to have a positive family history compared with those undergoing unilateral PK. Mean visual acuity was 20/60 at corneal thicknesses of 539 to 650 microns, 20/60 at 651 to 750 microns and 20/80 at greater than 750 microns. Patients who underwent bilateral PK and had a preceding cataract extraction on one eye required PK of the pseudophakic eye on average 3.2 years earlier than the fellow eye. The mean time from cataract extraction to PK was 2.2 years.

The study affirms that Fuchs’ dystrophy is a disorder of aging that predominantly affects women and is often familial. Pachymetry-determined corneal thickness was a poor predictor of visual acuity until extreme levels of corneal edema were reached. Cataract extraction in an eye with Fuchs’ dystrophy leads to earlier PK.

SOURCE: Afshari NA, Pittard AB, Siddiqui A, Klintworth GK. Clinical study of Fuchs’ corneal endothelial dystrophy leading to penetrating keratoplasty: a 30-year experience. Arch Ophthalmol 2006;124(6):777-80.
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Accuracy of Self-Reporting of Medication Regimen in Glaucoma Patients

Researchers at Philadelphia’s Wills Eye Hospital evaluated the accuracy of self-reporting of the prescribed medication regimen in a glaucoma population, identified contributing factors and assessed the effect of written instructions on adherence to the regimen.

All patients at an urban resident glaucoma clinic were offered participation in the prospective, case-controlled study. Two trained interviewers administered a confidential questionnaire consisting of six questions about the name and dosage of ophthalmic medications, patient education level, patient’s ability to read and patient age. Interviewers recorded verbatim responses for each question. At the end of the visits, all patients received a written chart describing their ophthalmic medications, frequency and dosage. At their next scheduled visits, interviewers used the same questionnaire. The patients' responses from both visits were compared with the regimen they were prescribed and with one another. The data was used to determine the accuracy of reporting medications.

In all, 193 patients were enrolled in the study over a 10-month period; 164 patients completed both phases (85 percent completion rate). The study population consisted of 85 women and 79 men with a mean age of 68.40 +/- 11.6 years. Eighty-four patients had attained less than 12th grade education and 80 had completed high school. At the first visit, 66 patients (40 percent) showed less than 100 percent accuracy. Forty-nine of 84 patients (58 percent) who had not completed high school education showed less than 100 percent accuracy with a mean score of 65 percent, whereas 17 of 80 patients (21 percent) who had completed high school showed less than 100 percent accuracy with a mean score of 87 percent. After written instruction, the accuracy of reporting improved by 23.36 +/- 30.8 percentile points in patients who hadn’t completed high school and improved by 8.46 +/- 21.7 percentile points in patients who had completed high school. The mean number of ophthalmic medications prescribed was 2.10 +/- 0.93 (range 1 to 4). Patients on one medication had 100 percent accuracy in reporting 82 percent of the time; those with four medications had 100 percent accuracy 21 percent of the time. Gender, age and race of patients did not correlate with the accuracy of self-reporting.

The results showed that patients showed improved accuracy of reporting medications when they were given written instructions about their regimen, regardless of their level of education or number of medications.

SOURCE: Kharod BV, Johnson PB, Nesti HA, Rhee DJ. Effect of written instructions on accuracy of self-reporting medication regimen in glaucoma patients. J Glaucoma 2006;15(3):244-7.
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Family History of IBD in Patients with Idiopathic Ocular Inflammation

A family history of inflammatory bowel disease (IBD) may be an independent risk factor for the development of ocular inflammation, according to a retrospective observational study by the University of Illinois Eye Center.

Researchers screened the medical records of idiopathic ocular inflammation patients seen between January 1995 and June 2005 in the University of Illinois Uveitis Clinic for a family of IBD. Family history included first-, second- and third-degree relatives.

A total of 727 patients (32.8 percent) had idiopathic ocular inflammation. Twenty-six of 727 (3.6 percent) reported a family history of ulcerative colitis and 10 of 727 (1.4 percent) reported a family history of Crohn's disease. Sixteen patients (2.2 percent) with a family history of indeterminate colitis were excluded from subsequent comparisons. The prevalence of a family history of IBD among patients with idiopathic ocular inflammation was three- to 15-fold higher than the prevalence of ulcerative colitis and Crohn's in the general population. Keratoiritis was more common and granulomatous disease less frequent in patients with a family history of IBD. A total of 26.3 percent of patients tested who had a family history of IBD and 66.7 percent of patients tested who had IBD themselves were HLA-B27 positive, compared with 40.1 percent of patients with neither a family history of IBD nor IBD themselves.

The study authors believe that, in contrast to the subgroup of patients with a personal history of IBD, HLA-B27 may not be an appropriate marker in the subgroup of patients with only a family history of IBD. They emphasize the importance of investigating other immunologic factors that may predispose patients with IBD and their relatives to ocular inflammation.

SOURCE: Lin P, Tessler HH, Goldstein DA. Family history of inflammatory bowel disease in patients with idiopathic ocular inflammation. Am J Ophthalmol 2006;141(6):1097-104.
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BRIEFLY
  • FDA APPROVES LUCENTIS FOR TREATMENT OF WET AMD. The FDA has approved Genentech’s Lucentis (ranibizumab injection 0.5 mg) for treating neovascular (wet) age-related macular degeneration (AMD). Lucentis was approved following a Priority Review; the drug is scheduled to ship immediately. In Phase III clinical trials, 95 percent of patients treated with Lucentis maintained their vision; vision improved by at least three lines (or 15 letters) on the study eye chart in up to 40 percent of these patients at one year. Lucentis is designed to inhibit the formation and leakage of new blood vessels in the back of the eye, the primary cause of central vision loss associated with AMD. It’s recommended for intravitreal injection once a month; if monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections, but this dosing may lead to an approximate five-letter (one-line) loss of visual acuity benefit, on average, over the following nine months. Patients should be evaluated regularly.
  • IMPLANTS OF EYEONICS’ CRYSTALENS SURPASS FIFTY THOUSAND. Eyeonics Inc., the maker of Crystalens, an accommodating intraocular lens (IOL), has announced that more than 50,000 Crystalens IOLs have been implanted worldwide since the device was approved by the FDA in November 2003. Of these, 17,000 have been Eyeonics’ second-generation Crystalens SE accommodating lens, a biconvex silicone plate lens with a 4.5 mm optic. The lens is made of the same material as the original Crystalens but has a 360-degree square edge on the lens’ posterior side. Studies have shown that the square-edge design inhibits lens epithelial cell migration. The Crystalens devices are designed to allow the lens to move in the eye in a manner similar to the natural lens, thus allowing patients to focus through a continuous range of vision. For more information about Crystalens IOLs, go to www.crystalens.com.
  • ISTA FILES NDA FOR TOBRAMYCIN-PREDNISOLONE TREATMENT. ISTA Pharmaceuticals has filed a New Drug Application with the FDA for its investigational ophthalmic product, T-Pred (prednisolone acetate 1.0% and tobramycin 0.3%). The company is seeking approval for T-Pred as a treatment for inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial ocular infections or a risk of bacterial infections exists. In a Phase III trial, T-Pred successfully achieved its primary endpoint and achieved or exceeded its goal both in the intent-to-treat and the per-protocol patient populations. Pending acceptance and approval of the NDA submission for T-Pred, ISTA anticipates launching the product in mid-2007.


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