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Veteran researcher offers tips on conducting trials
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NEW YORK – Retrospective case series research is a good place for optometrists who are interested in participating in clinical studies to get started, according to an experienced researcher.
Loretta Szczotka-Flynn, OD, PhD, FAAO, shared tips on getting involved in clinical trials during the Global Contact Lens Forum, held prior to Vision Expo East.
“Industry funded studies are good opportunities,” Szczotka-Flynn said. “I participated in all 30-day continuous wear contact lens trials.”
An area such as this that is regulated by the FDA or industry is rigorously monitored, she said.
“It’s not for those who just want to dabble in research,” Szczotka-Flynn said. “You have to have a dedicated study coordinator and strict recruitment and retention. Dropouts look worse than not recruiting at all,” so patient selection is critical.
“Retain all source documentation, “even if it’s a sticky note where you write the K readings,” she said.
Study monitors will come into your office to evaluate your practices, Szczotka-Flynn continued.
“You have to be willing to accept people looking over your shoulder and criticizing you,” she said.
She encouraged further education, such as the clinical education offered at large meetings like the American Academy of Optometry and the Association for Research in Vision and Ophthalmology.
“Training grants are available to provide salary support and dedicated time to seek a further degree or education in research,” she said. “My PhD work was the basis of the Longitudinal Analysis of Silicone Hydrogel (LASH) Contact Lens Study that looked at 205 patients who wore contact lenses continuously for 30 days and evaluated corneal infiltrates.
“I partnered with Alcon to do a similar study in daily wear,” she continued. “I have partnered with Johnson & Johnson Vision Care. I have performed three very large-scale, 1-year clinical trials looking at infiltrates in contact lens wearers.”
Szczotka-Flynn encourages collaboration.
“You’re only as smart as the team you’re surrounded with,” she said.
She is involved in the Cornea Preservation Time Study (CPTS), which has enrolled 1,300 at 40 sites across the country to evaluate corneal transplant surgery with a 5-year follow-up. It is sponsored by Case Western Reserve University, where Szczotka-Flynn works, in collaboration with the National Eye Institute and the Jaeb Center for Health Research.
She is also involved in the ongoing Dry Eye Assessment and Management (DREAM) study, sponsored by the University of Pennsylvania in collaboration with the National Eye Institute. According to www.clinicaltrials.gov, the objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease. – by Nancy Hemphill, ELS, FAAO
Reference:
Davis R, et al. Evidence based eye care and clinical practice: A review of research in clinical practice. Presented at: Vision Expo East, New York. March 30-April 2.
Disclosures: Szczotka-Flynn is a consultant for Alcon and Johnson & Johnson Vision Care.