CLAY Group Models as a Study Team With Support

By
Dr. Kathryn Richdale

Kathryn Richdale, OD, PhD, FAAO, and Heidi Wagner, OD, MPh, FAAO, have both been involved in clinical study groups before. Some of those are of short duration and highly focused. Others last a little longer. And very occasionally, they find themselves in one like the Contact Lens Assessment in Youth (CLAY) group, which has been ongoing since it was founded in 2008 and has become a mentoring and nurturing organization for the seven women and one man who now comprise the group. Dr. Richdale and Dr. Wagner are the co-chairs. Dr. Richdale is from State University of New York State College of Optometry, and Dr. Wagner is at Nova Southeastern University College of Optometry.

Dr. Heidi Wagner

CLAY formed at the American Academy of Optometry (AAO) and American Optometric Association (AOA) summer research institute, and the group has taken on a special dynamic to the women involved. “We have a very supportive group. There’s great mentorship because we’re at different stages of our careers,” says Dr. Richdale. The fact that the group is primarily women seems to have fostered an unusual group dynamic for a study group: chaired by women and comprised mostly of women. Dr. Wagner says, “The hope is that the summer research institute is like an incubator. Some study groups will continue in a small way, and some will really take hold.” Dr. Richdale adds, “I don’t think there are many other groups like this. It brings together clinicians, educators and researchers with diverse strengths and skills from six schools and colleges of optometry.”

The more established the group becomes, the more new possibilities emerge for it, too. The members meet in weekly conference calls and in person at the AAO and Association for Vision Research in Ophthalmology meetings. “We meet in person when we need a few days together to dig through data or write a paper,” says Dr. Wagner. Its initial focus was on promoting contact lens safety and understanding habits of younger wearers, but the group has expanded its reach to include what it believes is the highest-risk group, older teens and young adults, up to age 25.

The CLAY study group reported a record review of more than 3,500 patients, including 1,100 minors, and showed an increase in the rate of corneal infiltrative and inflammatory events (CIEs) in 14- to 25-year-olds. The rate of CIEs was lower for children (8-13 years) and adults 26 and older. Behaviors like showering and napping in soft contact lenses, as well as illness, lack of sleep and other immune stresses also peaked in this age group, the researchers said. To help meet the opportunity and need to provide better education to this population and help all wearers be successful with contact lens wear, the CLAY group has developed the Contact Lens Risk Survey (CLRS), the first standardized risk assessment survey designed to assess behaviors and exposures that place wearers at increased risk of complications.

The CLAY study group, back row (l-r): Beth T. Kinoshita, OD, FAAO;
Dr. Wagner; and G. Lynn Mitchell, MaS, FAAO.
Front row (l-r): Dawn Y. Lam, MSc, OD, FAAO; Dr. Richdale;
Aaron Zimmerman, OD, MS, FAAO; Robin L. Chalmers, OD, FAAO;
and Luigina Sorbara, OD, MSc, FAAO.

“Adulthood doesn’t happen overnight. There are issues that these young people are not ready to manage on their own,” says Dr. Wagner. “They have to learn how to access and plan for health care. So our group would like to look at safety but also at how we communicate those messages to this audience. These aren’t the people who are watching the 6 o’clock news.”

Because this tool can distinguish behaviors related to risk of having any contact lens complication and having a serious and significant complication, the group is working to make the CLRS available to all eye care providers as a tool to provide focused patient education quickly and efficiently. CLAY is funded by an unrestricted grant from Alcon, with additional periodic support from others, such as Nova Southeastern University, and logistical support from the AAO and the AOA.

With its more recent work, the CLAY group has now had a look at both ends under the umbrella of youth and contact lens wear. “We started out looking at the young end of the risk curve. Can young children safely wear contact lenses? The good news is that they can, especially with more optometrists recommending daily disposable contact lenses.”

There’s still more to do, however. Dr. Richdale says the group plans to write a proposal for National Institutes of Health funding. “We started with a retrospective record review from charts in clinics,” says Dr. Wagner. “Then we developed our survey. We are now doing prospective work with patients with contact lens-related red eye.” The more they uncover, the more they discover there is to analyze. A large-scale, multisite clinical trial could help better establish relationships between behavioral and environmental factors and contact lens complications.

The end goal is to enable a lifetime of healthy contact lens wear. “If a young patient is going to wear contact lenses at age 7 to slow the progression of myopia, we want that per- son to be able to wear contact lenses—without infections or pain—until he or she is 70,” says Dr. Richdale.