Off the Cuff: Contributing to the Future

As a resident in 1977 with a primary interest in disorders of the retina, I quickly grew frustrated with the lack of effective treatments for many of the patients I was managing. The final straw was a young man — a talented artist from the Middle East -- whom I watched go blind from Leber’s optic atrophy. There was nothing I could do.

Although my clinical interest has shifted from the retina to the anterior segment, I still pay close attention to advances in all aspects of ocular disease management. Retinal surgery has changed dramatically from the gravity-table to vitrectomy, microsurgery and even macula translocation. As exciting as these new developments are, it’s easy to envision when more effective medical therapies will replace most surgeries and eliminate blindness in our lifetime. These are efforts in which we can and should be involved today, rather than simply waiting for the future. One way is to get involved in clinical trials.

I recently received an information package about an ongoing FDA Phase III clinical trial from the Foundation Fighting Blindness. The trial is for Alcon’s anecortave acetate, an angiostatic agent that has shown tremendous promise for treatment of wet AMD. This is the first time (that I am aware of) that O.D. referrals have been actively solicited for a retinal treatment clinical, making it a major step in the right direction for our patients and for our relations with retinal subspecialists. Kudos to both the Foundation Fighting Blindness and Alcon Laboratories for their forward thinking.

For additional information regarding patient enrollment in this trial, call 866-692-5959; for more information about the Foundation, click here.

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

Progressives vs. Single Vision Lenses for Juvenile-Onset Myopia

The purpose of this Correction of Myopia Evaluation Trial (COMET), conducted by the New England College of Optometry, Boston, Mass., was to evaluate the effect of progressive addition lenses (PALs) compared with single vision lenses (SVLs) on the progression of juvenile-onset myopia. Researchers enrolled 469 children, ages 6 to 11 years (mean age at baseline 9.3 +/- 1.3 years), with myopia between –1.25 and –4.50D spherical equivalent. The children were recruited at four U.S. colleges of optometry and were ethnically diverse. They were randomly assigned to receive either PALs with a +2.00 addition (235 patients) or SVLs (234 patients), the latter being the conventional spectacle treatment for myopia. All patients were followed for 3 years. Primary outcome measure was progression of myopia, as determined by autorefraction after cycloplegia with 2 drops of 1% tropicamide at each annual visit; secondary outcome measure was change in axial length of the eyes, as assessed by A-scan ultrasonography. Researchers used child-based analyses (i.e., the mean of the two eyes), and adjusted results for important covariates using multiple linear regression.

Of the 469 children, 462 (98.5 percent) completed the 3-year visit. Mean (+/- SE) 3-year increases in myopia (spherical equivalent) were –1.28 +/- 0.06D in the PAL group and –1.48 +/- 0.06D in the SVL group. The 3-year difference in progression of 0.20 +/- 0.08D between the two groups was statistically significant.

The treatment effect was observed primarily in the first year. The number of prescription changes differed significantly by treatment group only in the first year. At 6 months, 17 percent of the PAL group versus 30 percent of the SVL group needed a prescription change; at 1 year, 43 percent of the PAL group versus 59 percent of the SVL group required a prescription change. Interaction analyses identified a significantly larger treatment effect of PALs in children with lower versus higher baseline accommodative response at near and with lower versus higher baseline myopia. Mean increases in the axial length of eyes of children in the PAL and SVL groups, respectively, were: 0.64 +/- 0.02mm and 0.75 +/- 0.02mm, with a statistically significant 3-year mean difference of 0.11 +/- 0.03mm. Mean changes in axial length correlated with those in refractive error (r = 0.86 for PAL and 0.89 for SVL).

Study authors concluded that the use of PALs compared with SVLs slowed the progression of myopia in COMET children by a small, statistically significant amount only during the first year, and that the size of the treatment effect remained similar and significant for the next 2 years. The results provide some support for the COMET rationale--that is, a role for defocus in progression of myopia--but the small magnitude of the effect does not warrant a change in clinical practice.

SOURCE: Gwiazda J, Hyman L, Hussein M, et al. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. J Invest Ophthalmol Vis Sci 2003;44(4):1492-1500.

Uveitis a Risk Factor for Rhegmatogenous Retinal Detachment

A study by the F.C. Donders Institute of Ophthalmology in Utrecht, The Netherlands, shows a high prevalence of rhegmatogenous retinal detachment (RRD) in patients with active panuveitis and infectious uveitis, and suggests that uveitis in itself is a risk factor for the development of RRD.

In a retrospective case-control study, researchers included 1,387 consecutive patients with uveitis who consulted their uveitis clinic from January 1990 through December 1997. Of these, 43 patients (46 eyes) with RRD were identified. The retinal detachment (RD) controls were 212 consecutive patients with RRD (221 eyes, first occurrence of RD, not associated with uveitis) who were admitted for surgery in the period from April 1999 to April 2000. The uveitis control group consisted of 150 age-matched patients (210 eyes) selected from the entire uveitis series. Main outcome measures included the presence of RRD and eventual risk factors for RRD, such as myopia, retinal lattice degeneration, prior intraocular surgery, anatomic location of uveitis, its specific diagnosis and clinical manifestations. Surgical and nonsurgical outcomes of RRD and the results of various treatment regimens were also analyzed.

RRD was identified in 3.1 percent of the patients with uveitis. It was most frequently associated with panuveitis (6.6 percent), and was associated more frequently with infectious (7.6 percent) than noninfectious uveitis (2.1 percent). At the onset of RRD, uveitis was active in most (46 percent) affected eyes. Proliferative vitreoretinopathy was present in 30 percent of the uveitic RRD eyes at presentation in contrast to 12 percent of the RRD control eyes. In uveitic RRD, the retina was reattached in 59 percent of eyes with a single operation; the final anatomic reattachment rate was 88 percent. Finally, a visual acuity of less than 20/200 was present in 71 percent of the uveitic RRD eyes, 10 percent of which had no light perception. Visual prognosis of RRD in uveitis was poor because of the uveitis itself and the frequent development of proliferative vitreoretinopathy.

SOURCE: Kerkhoff FT, Lamberts QJ, Van Den Biesen PR, Rothova A. Rhegmatogenous retinal detachment and uveitis. Ophthalmol 2003;110(2):427-31.

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Alcohol Delamination May Be Ideal Preparation for PRK and LASEK

Alcohol delamination of the corneal epithelium (CE) before photorefractive keratectomy (PRK) or laser epithelial keratomileusis (LASEK) consistently results in a very smooth cleavage at the level of the hemidesmosomal attachments. It leaves a very smooth surface, ideal for PRK, and because it allows for an intact epithelial flap to be lifted as a sheet from the corneal surface, it is also well-suited for the LASEK technique. These are the findings of a U.K. study by the University of Nottingham and the Birmingham and Midland Eye Centre.

Researchers fixed and processed the epithelial flap from six patients undergoing alcohol delamination of CE before PRK and the epithelium and stroma from three eye bank donor eyes. They studied the smoothness of the underlying stroma using scanning electron microscopy (SEM) and determined the plane of cleavage by morphologic examination and morphometric measurements of basement membrane attached to the epithelial flap, using image-analysis software. They saw a very smooth bed, ideal for PRK, in the stroma of all three eye bank donor eyes after alcohol delamination. The plane of cleavage was determined to be at the hemidesmosomal attachments, including the most superficial part of the lamina lucida of the basement membrane.

SOURCE: Browning AC, Shah S, Dua HS, et al. Alcohol debridement of the corneal epithelium in PRK and LASEK: an electron microscopic study. Invest Ophthalmol Vis Sci 2003;44(2):510-13.

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CCT in Assessing Glacomatous Damage in Ocular Hypertension Patients

It has been suggested that a considerable subset of patients currently classified as having ocular hypertension may have thicker-than-average corneas that result in an overestimation of the true intraocular pressure (IOP). As a consequence, ocular hypertension patients with greater corneal thickness may be at a lower risk for functional damage, such as that detected by short-wavelength automated perimetry (SWAP). A study by the Hamilton Glaucoma Center and Visual Function Laboratory, Department of Ophthalmology, University of California, San Diego, found that patients with ocular hypertension but with visual field loss detected by SWAP had significantly lower central corneal thickness (CCT) measurements than ocular hypertension patients with normal visual field results. Results of the study suggest that CCT should be taken into account when assessing risk for the development of glaucomatous damage among ocular hypertension patients.

Sixty-eight ocular hypertension patients with normal optic disks and 63 normal subjects underwent standard automated perimetry (SAP), SWAP, and CCT measurements using ultrasound pachymeter. CCT measurements in ocular hypertension patients with abnormal visual field test results were compared with CCT measurements in ocular hypertension patients with normal visual field results. CCT measurements in ocular hypertension patients were also compared with the same measurements in normal subjects.

Sixteen of 68 patients with ocular hypertension (24 percent) demonstrated SWAP abnormalities, whereas four of 68 (6 percent) showed a deficit on SAP. The mean CCT in ocular hypertension patients with abnormal SWAP results was significantly lower than the mean CCT in ocular hypertension patients with normal SWAP results (545 +/- 25 microm vs. 572 +/- 35 microm). The mean CCT in the normal group was 557 +/- 33 microm. The mean CCT in ocular hypertension patients with normal SWAP results was significantly higher than in normal subjects; no significant difference occurred between mean CCT in normal subjects and in ocular hypertension patients with abnormal SWAP results.

SOURCE: Medeiros FA, Sample PA, Weinreb RN. Corneal thickness measurements and visual function abnormalities in ocular hypertensive patients. Am J Ophthalmol 2003;135(2):131-7.

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NEWS & NOTES

	NEW GP LENS DEBUTS. In a joint venture, X-Cel Contacts and Blanchard Contact Lens have developed a new GP contact lens design for presbyopic patients. ESSential Solution lenses employ Blanchard’s proprietary "S-Form Technology" for the aspheric multifocal posterior surface and X-Cel’s proprietary Solution Bifocal for the anterior surface design. The combination creates a segmented aspheric multifocal GP lens with full-range vision correction, a thin lens profile and decreased mass. The ESSential Solution lens is available in base curves of 7.10mm to 8.20mm (.10mm increments), +6.00D to –10.00D (0.25D increments), diameters of 9.0, 9.3, and 9.6mm, add corrections of 0.75D to 3.50D (0.25D increments) and prism ballast of Minimum, Medium and Maximum at 90° +/- 20°. It is available from all X-Cel Contacts laboratory locations, with full warranty exchange and cancellation privileges. For more information, click here, or call 800-367-4009 (Blanchard) or 800-241-9312 (X-Cel Contacts).
	ALLERGAN APPEAL OF PATENT BREACH DENIED. A U.S. appeals court has upheld district court orders dismissing lawsuits brought by Allergan, Inc. alleging infringement of patents on its glaucoma drug, Alphagan. The cases involved proposed generic versions of Alphagan made by Alcon, Inc. and Bausch & Lomb, Inc. Allergan voluntarily withdrew Alphagan from U.S. distribution last summer; the company says that the ruling does not affect its next-generation version of the drug, which has a lower dose and lower incidence of adverse events.
	ZYMAR APPROVED AS OPHTHALMIC ANTI-INFECTIVE. The FDA has approved Allergan’s anti-infective fluoroquinolone, Zymar (gatifloxacin ophthalmic solution) 0.3%, for treatment of bacterial conjunctivitis caused by susceptible strains of bacteria. Zymar is the first fourth-generation fluouroquinolone to enter the market; Allergan describes it as a "highly efficacious fluoroquinolone with complete solubility, effective tissue penetration and low MIC 90s against a broad spectrum of organisms." The most frequently reported adverse events in the overall Zymar study population were conjunctival irritation, increased tear secretion, corneal inflammation and papillary conjunctivitis. These events occurred in approximately 5 to 10 percent of patients. Other reported reactions occurring in 1 to 4 percent of patients were: swelling of tissue surrounding the cornea, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid swelling, headache, red eye, reduced visual acuity and taste disturbance. Zymar is expected to be available on April 30.
	VISTAKON SURVEY: PATIENT PERCEPTIONS OF ROUTINE EYE EXAMS. A recent consumer survey by Johnson & Johnson’s Vistakon division showed that nearly 30 percent of vision-corrected patients believe that their eye doctor checks only vision quality and not other health problems during a routine eye exam. While nearly all respondents knew that eyecare professionals can detect glaucoma (96 percent) and cataracts (95 percent), fewer realized that an eye doctor can identify signs of diabetes (57 percent), hypertension (51 percent), stroke (30 percent), high cholesterol (17 percent), and multiple sclerosis (14 percent). Ninety-one percent believe that getting their eyes checked regularly is as important as regular visits to a dentist; once respondents realized that eye doctors can detect signs of many health conditions in a routine eye exam, one-half said they would be more likely to get their eyes checked annually and 57 percent said they felt more positive about the value of regular eye exams.

	It's only been up and running a few short weeks. Yet, it's already clear that the Check Yearly. See Clearly.(SM) marketing campaign is opening consumers' eyes to the benefits of regular eye exams. Call the Vision Council of America at 800-424-8422 today or visit checkyearly.com for your free promotional materials.