In a recent clinical trial comparing the effectiveness of atropine to patching for the treatment of moderate amblyopia in children with poor visual acuity, researchers from the Pediatric Eye Disease Investigator Group found that the eye drop performs better than previously thought. The study appeared in the August issue of Ophthalmology.

In fact, physicians believe that the study's results will likely change current opinion that atropine is a less effective treatment than patching in children with poor vision, based on earlier retrospective case reports. In the multicenter trial, 419 children—ages 3 years to under 7 years, with visual acuity between 20/40 and 20/100—were randomly assigned to receive one drop of atropine 1% q.d. in the sound eye, or undergo six to 10 or more hours of patching for six months. Researchers evaluated whether the treatment benefit of the two modalities differed by patient age, cause of amblyopia and depth of amblyopia.
Investigators reported that "substantial improvement in the visual acuity of the amblyopic eye occurred with both the patching and the atropine treatment regimens" for children of all ages with acuities between 20/40 and 20/100.
Patients with visual acuity of 20/80 to 20/100, who were prescribed 10 or more hours of patching, showed a more rapid improvement in vision by the five- and 16-week examination than those prescribed fewer hours of patching or than patients in the atropine group. But by six months, the difference in acuity between the atropine and patching groups was minimal—approximately one-third of a line. While both treatments were well-tolerated, atropine was favored by parents in a patient questionnaire administered after the first five weeks of treatment.

Beyond its effectiveness in treating amblyopia, patients in this study preferred atropine treatment over patching.

The treatment effects didn't vary with age, cause of amblyopia (strabismus or anisometropia), depth of amblyopia, race, gender or refractive error of the good eye.

Many pediatric ophthalmologists use atropine sparingly and only as a second-line remedy if patching fails. Doctors may now be inclined to use the drop more frequently, because of its proven effectiveness for treating children with poorer acuity, and its ability to facilitate patient compliance, a huge issue in amblyopia treatment, says Harold P. Koller, MD, FACS, FAAP, a clinical professor of ophthalmology at Thomas Jefferson University, and attending surgeon at Wills Eye Hospital in Philadelphia.

"I think physicians will continue to patch [short term], but as the months go by and the study is publicized, they will use atropine as their first-line treatment," says Dr. Koller, who plans to begin using atropine as his initial treatment choice in light of the study findings. "In the population of children who reject patching, atropine is extremely effective," he says.

David Stager, Jr., MD, FACS, associate clinical professor of ophthalmology at the University of Texas Southwestern Medical Center in Dallas, says that he will use atropine more frequently as an alternative whenever patching becomes difficult for his patients. "The study surprised many pediatric ophthalmologists," says Dr. Stager. "They were skeptical about atropine's effectiveness, but the data show that atropine is very effective in restoring visual acuity to 20/30 [in children whose vision was 20/100]. And I also believe that the study will change how pediatric ophthalmologists treat amblyopia."

Lead study investigator Michael X. Repka, MD, professor of ophthalmology at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, says the study shows that "parents won't be using a poor second-best treatment and that [the drug] is a good alternative. Atropine now can be viewed as a first-line approach for some children."

Despite the drug's newfound effectiveness, side effects remain a concern and have long hindered its more widespread use. "Photosensitivity is a concern because the good eye is chronically dilated," says Dr. Stager. "Some doctors worry about the effects on accommodation. Atropine paralyzes the ciliary muscle, so doctors worry that long-term use of atropine may have deleterious effects on that muscle."

Some ophthalmologists thought at one time that patients given atropine wouldn't use their weaker eye, says Dr. Stager, but the study shows that they do.

Dr. Koller says that atropine can cause flushing and slow heart rate in some children. But he says that these adverse events usually occur with daily multiple dosing. On average, atropine may be prescribed once a day for three to six weeks or until there's no further improvement in acuity for two to three months of use, says Dr. Koller. "One drop doesn't cause much of an effect," he says. "It may cause the [child's] cheeks to become red for 15 to 20 minutes, but that disappears. Typically, you have to use atropine several times a day to develop these effects. So it's very safe when using one drop per dose."

Early Results of Retisert Study
An analysis of 34-week data from the first Phase III randomized, multicenter, masked, controlled clinical trial assessing the safety and efficacy of Bausch &Lomb's Retisert intravitreal implant for the treatment of non-infectious posterior uveitis were presented at September's annual meeting of the Retina Society in Chicago.

The 27-center trial includes 278 patients with non-infectious posterior uveitis randomized to receive a 0.5-mg or a 2-mg Retisert implant in the affected eye, or in bilateral cases, in the more severely afflicted eye. The fellow eye was implant-free. The implant delivers sustained, consistent levels of fluocinolone acetonide directly to the back of the eye for up to three years.

Lead investigator Glenn J. Jaffe, MD, professor of Ophthalmology, Vitreoretinal Diseases and Surgery at Duke University Eye Center, Durham, N.C., reported that at 34 weeks, the uveitis recurrence rate was statistically lower (p<0.0001) in eyes with the Retisert implant (2.9 percent) compared to the recurrence rate in the fellow eyes (43.7 percent).

In the implant eyes, there also was a statistically significant improvement in visual acuity (p<0.0001). Baseline mean visual acuity was 20/68 and improved to 20/58 after implant; 25.9 percent of the implant eyes improved by three or more lines. Fellow-eye mean visual acuity at baseline was 20/42 compared to 20/44 at 34 weeks (p=0.28).

Overall, the use of systemic corticosteroid and/or immunosuppressive therapy decreased. At enrollment, 59.0 percent of patients were using systemic corticosteroid and/or immunosuppressive therapy compared to 13.7 percent at 34 weeks (p<0.0001). Similarly, the use of periocular steroid injections and steroid drops significantly decreased post implantation. In the 12 months before implantation, 70.5 percent of implant eyes received periocular injections compared to 2.2 percent afterward (p<0.0001). Use of periocular injections was unchanged in the fellow eyes, 29.5 percent in the 12 months prior versus 32.3 percent in the 34 weeks after enrollment (p=0.36).

Topical steroids were being used in 28.7 percent of the implant eyes at enrollment compared to 8.3 percent 34 weeks after implantation (p<0.0001). In fellow eyes, topical corticosteroid use significantly increased from 16.5 percent at enrollment to 24.1 percent.

The most common adverse events, cataract progression and increased intraocular pressure, were managed by conventional means. Pressure-lowering drugs were being used in 34.9 percent of the implant eyes and 11.5 percent of the fellow eyes compared to 8.6 percent of implant eyes and 6.8 percent of the fellow eyes at enrollment. Filtering surgeries were required to control the pressure in 8.6 percent of the implant eyes; 13.5 percent of implant eyes underwent cataract extractions compared to 1.5 percent in fellow eyes. Patients will be followed for an additional two and a half years.

New Group Aims to Connect Women in Ophthalmic Industry
Organizers of a new industry group hope to provide a unique and first-ever opportunity for professional women in the ophthalmic industry to network and benefit from each others' experience. Still in its formative stage, the organization has tapped women and other advisors who have achieved the leadership positions it hopes to help other women realize.

Marguerite McDonald, MD, a clinical professor of ophthalmology at Tulane University and director of Southern Vision Institute, is part of OWL's advisory committee. She sees great potential for networking and mentoring.
"Networking is important because sometimes another woman can look you in the eye and say, 'You mean you've been the top salesperson in your region for 15 years and you've never been promoted? Here's my card, why don't you come to my company; we encourage people like you,' " says Dr. McDonald.
Such opportunities may be especially valuable to younger women who aspire to leadership positions in industry. "A lot of the younger women haven't really smacked their heads on the glass ceiling yet," says Dr. McDonald. "When you're a new sales rep in your early 20s, it might take a few years before you are even troubled by the fact that your company doesn't have a single female regional manager, or very few. It might not strike you that you've been passed by—in spite of an excellent performance—until you're 37."

Adrienne Graves, PhD, president and CEO of Santen Inc., another advisory committee member, adds, "There is an untapped opportunity to offer women in our industry a new outlet for communication, education and development of strong relationships. Our goals are to support an exchange of ideas and information throughout a network of physicians, scientists, marketing and finance experts, presidents and CEOs. By providing educational opportunities, we will promote career development for professional women in the industry. Moreover, we will serve as mentors to women who aspire to leadership."
OWL plans to host two cocktail receptions, one at next month's Academy of Ophthalmology meeting, another at next spring's ASCRS meeting, to gauge interest from prospective members. The longer-term depends on the response, both from members and from industry.

Dr. McDonald, also a member of Women in Ophthalmology, an established group with similar aims but focused on women physicians, says funding will be important to OWL's success. "In 10 years, a significant percentage of ophthalmologists will be female," she says. "Any company that's forward-thinking might think that it would be wise to start bonding with all of the young doctors in training, learning about and meeting their individual needs. There's going to be a tremendous amount of economic power in their hands. So, if a company didn't want to do so for altruistic reasons, financial reasons should be enough motivation for the decision makers to support both of these organizations."

She cites the benefits to WIO of corporate support from Advanced Medical Optics received through the influence of another OWL advisory board member, James Mazzo, AMO's president and CEO. "Jim is an outstanding example of someone who supports women in ophthalmology," says Dr. McDonald. "He has recently given a substantial annual donation to WIO, the biggest that WIO has ever received, to support two speakers per year, one each at our spring and fall meetings. Jim has shown his interest in supporting women ophthalmologists, and also has a track record of hiring capable women into senior positions at AMO. Therefore, we thought Jim was a great example of an influential corporate leader who's supportive of women in the practice and business of ophthalmology."

For information, contact OWL by e-mail at owlbox@cox.net. 

R&D Competition Seeks Entries
The Spanish National Organization of the Blind (ONCE) has announced the Third International Research and Development Competition in Biomedicine and New Technologies for the Blind. The biannual competition aims to promote scientific studies or technological developments that contribute to the social integration of the blind and visually impaired.

The areas of research covered by the prizes include engineering, artificial intelligence, IT, telecommunications, biotechnology and biomedicine. The first prize winner will receive $207,363.00 and the two runners-up each will receive $69,121.00. The last competition featured 94 projects from more than 12 countries.

Send all entries to the Secretary's office of the Third International Research and Development Competition in Biomedicine and New Technologies for the Blind, located in Calle José Ortega y Gasset, 18, 28006 Madrid, Spain by May 31, 2004.