Key takeaways:

• Optometrists can contribute to finding better treatments to take care of their patients.
• Various levels of participation are available, from investigator to industry consultant.

PHOENIX — Two speakers at Optometry’s Meeting urged optometrists to get involved in clinical trials to provide their patients with the best care.

Every drug that is prescribed and every device that is used started with a clinical trial, Roya Attar, OD, MBA, DHA, FAAO, FORS, associate professor and director of optometric services at University of Mississippi Medical Center, told attendees.

At Optometry’s Meeting, Mohammad Rafieetary, OD, FAAO, FORS, Dip ABO, ABCMO, and Roya Attar, OD, MBA, DHA, FAAO, FORS, urge optometrists to get involved in clinical trials to improve their patient care.

“The goal is to find better treatments to take care of our patients,” she said.

Clinical trials differ depending on the study design, such as interventional, observational, diagnostic, pragmatic, quality of life, adaptive, prevention and screening, Attar said. “Not everything has to be an interventional trial.”

Attar noted that it can take 10 to 15 years and possibly $1 billion to get a new drug to clinic. New treatments often seem expensive, but “[the companies are] trying to make that money back,” she said.

Co-presenter Mohammad Rafieetary, OD, FAAO, FORS, Dip ABO, ABCMO, of Charles Retina Institute, added that public and private financial supporters also need to be paid back.

According to Attar, optometrists are currently involved in “every dry eye study you look at, glaucoma studies, all myopia management studies ... presbyopia management.”

Rafieetary outlined relevant terminology.

• Randomization: The treatment is compared to another that is already available or placebo.
• Masking: Examiners involved will not know patients’ disease state or what treatment they are receiving.
• Control group: Also called “sham,” these participants will receive placebo or standard of care.
• Endpoint: One or two markers indicate whether the treatment or testing worked.
• Statistical significance: A challenge ensures the findings are not random.
• Adverse event: An unfavorable medical occurrence that may or not be related to the treatment.

Recruitment is one of the most difficult aspects of clinical trials, Rafieetary said. Researchers may have to go through a number of patients to finally find those suitable.

“Imaging and technology are very important,” he said. “Data collection is very much scrutinized.”

Attar explained how clinical trials work when evaluating drugs, devices, over-the-counter medications, diagnostics, software and surgical outcomes.

“I want to look first to see if this new possible treatment, diagnostic or screening is safe,” she said. “Then if it’s efficacious — that’s what each of the phases does — then at what dosing level.”

Attar outlined the phases.

• Phase 1: A small cohort of patients to evaluate safety.
• Phase 2: Determine if it is efficacious.
• Phase 3: Validation in a large cohort.
• Phase 4: Post-market surveillance.

She urged attendees to look at clinical trials as a way to continue to take care of patients who may have limitations such as insurance and transportation.

“Go to clinicaltrials.gov and see if there’s one available for them,” Attar said.

“Many of these trials don’t move forward because these sites fail to recruit enough patients. And that’s devastating because there are already a lot of funds dedicated to that.”

The majority of patients who enter clinical trials do so through their own research.

“Only 10% are hearing about it from their doctors,” she said.

To get started, Attar recommended getting Good Clinical Practice certification. Dedicated space, equipment, staff, patient volume and sponsor relationships are important.

Optometrists can also conduct their own research through an investigator-initiated trial, she said, by deciding on the question that needs to be answered and developing a protocol using a large language model. The American Optometric Association, American Academy of Optometry and industry offer research grants.

“If more optometrists get involved, we can change the paradigm,” Attar said.

Other ways to be involved include serving as a research coordinator, imaging specialist, clinical scientist or industry consultant or having a clinical research organization role, she said.

For more information:

Roya Attar, OD, MBA, DHA, FAAO, FORS, can be reached at rattar@umc.edu. Mohammad Rafieetary, OD, FAAO, FORS, Dip ABO, ABCMO, can be reached at mrafieetary@charlesretina.com.