Volume 5, Number 18
Monday, May 9, 2005



In this issue: (click heading to view article)
Treatment of Amblyopia in Children Aged 7 to 17 Years
Infective Keratitis in Elderly Patients
Corneal Astigmatism in Graves" Ophthalmopathy
Dietary Fat Intake and Early Age-related Lens Opacities
Briefly











Treatment of Amblyopia in Children Aged 7 to 17 Years

The Pediatric Eye Disease Investigator Group at the Jaeb Center for Health Research, Tampa, FL, conducted a randomized trial aimed at evaluating the effectiveness of treatment of amblyopia in children aged seven to 17 years.

At 49 clinical sites, 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group (two to six hours per day of prescribed patching combined with near visual activities for all patients, plus atropine sulfate for children aged 7 to 12 years) or an optical correction group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (two lines or greater) by 24 weeks were considered responders.

In 7- to 12-year-olds (404 patients), 53 percent of the treatment group were responders, compared with 25 percent of the optical correction group. In the group of 13- to 17-year-olds (103 patients), the overall responder rates were 25 percent and 23 percent, respectively, but they were 47 percent and 20 percent, respectively, among patients not previously treated with patching and/or atropine for amblyopia. Most patients, including responders, were left with a residual visual acuity deficit.

Investigators concluded that amblyopia improves with optical correction alone in about one-fourth of patients aged 7 to 17 years, although most patients initially treated with optical correction alone will require additional treatment for amblyopia. For patients 7 to 12 years, prescribing two to six hours per day of patching with near visual activities and atropine can improve visual acuity, even if the amblyopia has been previously treated. For patients 13 to 17 years, prescribing patching two to six hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated; however, investigators believe that it is of little benefit if amblyopia was previously treated with patching. The authors state that they do not yet know whether visual acuity improvement will be sustained once treatment is discontinued; therefore, conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study that they are conducting on patients who responded to treatment.

SOURCE: Scheiman MM, Hertle RW, Beck RW, et al.: Pediatric Eye Disease Investigator Group. Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol 2005;123(4):437-47. 		Table of Contents











Infective Keratitis in Elderly Patients

There are few clinical series in the literature of infective keratitis in the elderly, even though this age group constitutes a significant proportion of those affected by this condition. This study, by the Department of Clinical Ophthalmology and Save Sight Institute at Australia’s University of Sydney aimed to determine the incidence and risk factors for infective keratitis in those older than 60 years, the causative organisms, antibiotic susceptibilities, visual and tectonic outcome and surgical intervention rate.

Investigators identified 190 patients in a retrospective review of all patients aged 60 years and older admitted to the Sydney Eye Hospital with a diagnosis of infective keratitis between September 1998 and December 2002. Patients had a mean age of 75.5 (SD 9.6) years (range, 60 to 101). Local risk factors were found in 93.7 percent, and systemic risk factors in 27.9 percent. Researchers cultured organisms in 62.8 percent, and 7.9 percent had positive herpes simplex virus (HSV) polymerase chain reaction (PCR). Perforation or severe thinning occurred in 36 percent overall but in 80 percent among those with positive HSV PCR. A total of 43.7 percent required acute surgical intervention, with acute penetrating keratoplasty performed in 17.9 percent; 8.9 percent required evisceration. Mean presenting visual acuity was 1.82 (SD 1.24), equivalent to 6/300 (about 20/1000), excluding 26.3 percent with vision of light perception or worse. Mean final visual acuity was 1.24 (SD 1.16), equivalent to 6/100 (about 20/330), excluding 19.5 percent with vision of LP or worse.

The authors concluded that the microbiological spectrum of elderly patients is similar to that of younger age groups, except that HSV is more common and may increase the risk of severe corneal thinning and perforation. They also state that the results showed that most bacterial isolates remained sensitive to currently available antibiotic preparations.

SOURCE: Butler TK, Spencer NA, Chan CC, et al. Infective keratitis in older patients: a 4 year review, 1998-2002. Br J Ophthalmol 2005;89(5):591-6.		 Table of Contents












Corneal Astigmatism in Graves" Ophthalmopathy

Graves" ophthalmopathy may be associated with greater with-the-rule corneal astigmatism, which overall is not influenced by orbital, strabismus or eyelid surgery, according to a Belgian study.

The retrospective, non-randomized comparative observational case series included 109 patients with inactive Graves" ophthalmopathy and 109 age- and gender-matched control individuals without Graves" ophthalmopathy. All were examined with manual corneal keratometry. In the Graves" patients, 52 percent had a CT scan available for review, and 41 percent underwent orbital, strabismus and/or eyelid surgery with a follow-up of keratometry over a mean period of 1.7 years after surgery.

A statistically significant difference occurred between the Graves" and the control eyes at 3.00D to 3.25D in both eyes. The astigmatism was found to be greater at the meridians 95 to 100 degrees and 105 degrees -110 degrees in the right eyes only. In 10 (9 percent) Graves" patients, the astigmatism had caused newly acquired reduced visual acuity. Greater astigmatism in diopters did not correlate with specific CT scan findings. Following orbital, strabismus, and eyelid surgery, the diopters and meridians of the astigmatism did not change in 56 eyes (68 percent) and 66 eyes (81 percent), respectively. Investigators believe that the astigmatism may possibly be caused by soft-tissue fibrosis in the superolateral orbital region.

SOURCE: Mombaerts I, Vandelanotte S, Koornneef L. Corneal astigmatism in Graves" ophthalmopathy. Eye 2005;Apr 22:Epub ahead of print.		 Table of Contents





Dietary Fat Intake and Early Age-related Lens Opacities

Dietary fat may affect lens cell membrane composition and function, which are related to age-related cataract. In this study by the Nutritional Epidemiology Program and the Center for Ophthalmic Research, Harvard Medical School and Brigham and Women"s Hospital (Boston), investigators examined the association between long-term dietary fat intake and the prevalence of age-related nuclear, cortical and posterior subcapsular lens opacities.

The study included 440 women aged 53 to 73 years from the Boston area who were without previously diagnosed cancer, diabetes or cataract, selected from the Nurses" Health Study cohort. researchers calculated intakes of total fat and selected fatty acids as the average of intake data from five food-frequency questionnaires collected between 1980 and the study eye examination (1993 to 1995). Nuclear opacity was defined as grade greater than or equal to 2.5, cortical opacity as grade greater than or equal to 1.0, and posterior subcapsular opacity as grade greater than or equal to 0.5, according to the Lens Opacities Classification System III.

Significant positive associations occurred between linoleic and linolenic acid intakes and the prevalence of nuclear opacity. The odds ratios for nuclear opacity in women with intakes in the highest quartile and women with intakes in the lowest quartile were 2.2 (95 percent CI: 1.1, 4.6) for linoleic acid and 2.2 (95 percent CI: 1.1, 4.5) for linolenic acid. No significant associations were found between intakes of any type of fat and either cortical or posterior subscapular opacity. The authors concluded that high intake of the 18-carbon polyunsaturated fatty acids linoleic acid and linolenic acid may increase the risk of age-related nuclear opacity, but they believe that further study is needed to clarify the relation between dietary fat and cataract risk.

SOURCE: Lu M, Taylor A, Chylack LT Jr, et al. Dietary fat intake and early age-related lens opacities. Am J Clin Nutr 2005;81(4):773-9.		 Table of Contents





BRIEFLY
  • TWO-YEAR CLINICAL TRIAL DATA RELEASED FOR B&L’S RETISERT FOR POSTERIOR UVEITIS. The results of a two-year Phase IIb/III clinical trial of Bausch & Lomb’s Retisert (fluocinolone acetonide intravitreal implant) for the treatment of chronic, noninfectious uveitis affecting the posterior segment of the eye have been released. The trial, conducted at 26 centers in the United States and one center in Singapore, included 278 people with noninfectious posterior uveitis randomized to receive either a 0.59-mg or 2.1-mg implant in the affected eye, or in bilateral cases, in the more severely afflicted eye; the fellow eye was implant free. Results showed a statistically significant lower rate of disease recurrence in eyes with Retisert (11.2 percent) after two years, compared to the recurrence rate in the year prior to enrollment (59.7 percent) and compared to the rate in the fellow eyes (50.0 percent) after two years. There were also statistically significant decreases in systemic use of immunomodulatory therapy and in periocular corticosteroid injections after implantation. In the eyes with Retisert, a statistically significant improvement in visual acuity occurred after two years as well. The most common adverse events included cataract progression and increased IOP, which were anticipated given the nature of the disease and the type of drug used. They were managed by conventional means, including cataract surgery and the use of eye drops or filtering surgery to lower IOP. Patients in the study will be followed for an additional year. Bausch & Lomb aims to make Retisert available in mid-2005.
  • AMO TO ACQUIRE QUEST VISION TECHNOLOGIES. Advanced Medical Optics, Inc. (AMO) has exercised its option to acquire Quest Vision Technologies, Inc. Financial terms were not disclosed. The companies entered into a one-year research and evaluation licensing agreement in May 2004 to develop accommodating intraocular lens (IOL) technologies and designs to address presbyopia. At the time, AMO was given the option to acquire Quest Vision after one year. The accommodating IOL being designed through an AMO and Quest Vision collaboration provides accommodation by altering the shape of the optic with or without axial movement. AMO’s acquisition gives it access to novel accommodating IOL technologies that the company hopes will add breadth to its growing refractive IOL offering, which currently includes the ReZoom multifocal lens, which gained FDA approval in March 2005; the Verisyse phakic IOL; and the Tecnis multifocal IOL. ReZoom and Tecnis multifocal IOLs have CE Mark approval in Europe for treatment of presbyopia. For more information, go to www.amo-inc.com.
  • MACUGEN’S SAFETY PROFILE MAINTAINED DURING TWO-YEAR STUDY. Eyetech Pharmaceuticals, Inc. has announced that the safety profile of Macugen (pegaptanib sodium injection), which has been approved by the FDA for treating "wet" age-related macular degeneration, continues during the second year of treatment. No new safety concerns were identified in Year Two; the safety profile was similar to that described for the first year of the study. A pharmacokinetics safety study also showed that Macugen was well-tolerated, with no evidence of systemic vascular endothelial growth factor (VEGF) inhibition or clinically significant ocular inflammation. In the studies, 374 patients received 2,663 injections of Macugen during the second year (128 received 0.3 mg; 126 received 1 mg; 120 received 3 mg) and 51 patients received 388 sham injections. The most common ocular adverse events reported in the second year were transient and mild to moderate, and they were attributed to the injection procedure rather than the study drug. No new systemic safety concerns or ocular safety issues emerged. Overall, the mean number of treatments for all patients re-randomized to continue Macugen was seven out of eight possible treatments, indicating a high compliance rate (87.5 percent) throughout the second year regardless of the reported adverse events. Overall, the mean number of treatments for the two years for all patients re-randomized to continue Macugen therapy was 16 out of 17 possible treatments, indicating a compliance rate of 94 percent throughout this two-year period regardless of the reported adverse events.
  • IMMUNE RESPONSE GENE VARIATION MAY CAUSE AMD. A study by Columbia University (New York) and University of Iowa suggests that age-related macular degeneration (AMD) may occur when a common inherited gene variation is triggered, possibly by infection. The gene, known as Factor H, encodes a protein that regulates immune defense against infection caused by bacteria and viruses. Those with an inherited variation in this gene, say the study’s authors, are less able to control inflammation caused by these infections, which may spark AMD later in life. The study, which was recently published in the Proceedings of the National Academy of Sciences, also suggests that targeting the molecules involved in this immune system response may provide powerful new therapies for treating and preventing AMD. Although other recent research has established the link between the Factor H gene and AMD by scanning the human genome for variations in gene sequences, this study is the first to examine the biological roots of AMD and explore the role that immune response plays in triggering the disease. The researchers made their discovery by studying a rare form of kidney disease called MPGN II; patients with this disease often share the same kind of eye lesions as those with AMD. They intend to launch additional studies based on their results.
    SOURCE: Hageman GS, Anderson DH, Johnson LV, et al. A common haplotype in the complement regulatory gene factor H (HF1/CFH) predisposes individuals to age-related macular degeneration. Proc Natl Acad Sci USA; online before print, May 3, 2005.
  • ENZYME MAY REDUCE IOP INCREASES AFTER CATARACT SURGERY. Halozyme Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, has announced the results of preclinical studies with its recombinant human PH20 (rHuPH20) hyaluronidase enzyme. The preclinical safety and pharmacology animal studies showed that when viscoelastic agents commonly used in cataract surgery were left in the eyes of animals, injection of Halozyme"s rHuPH20 enzyme into the front of the eye significantly reduced the incidence and severity of intraocular pressure (IOP) rises. Such pressure "spikes" are believed to occur when viscoelastic materials used in the surgical procedure clog the eye"s drainage canals and prevent fluid from properly draining from the eye. The data also showed that injection of rHuPH20 into the front of the eye caused no toxicity to the corneal endothelial cells in the eye. The enzyme, a highly purified, recombinant form of the naturally occurring human enzyme hyaluronidase, is being investigated for its ability to break down hyaluronic acid. It can degrade most viscoelastic agents used in clinical practice and might therefore be useful as a viscoelastic "antidote" in patients undergoing cataract surgery.


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