Getting products approved by the U.S. Food and Drug Administration (FDA) for a treatment is a long and complex process. In 2019, the MiSight lens from CooperVision became the first—and to date the only—soft contact lens to receive FDA approval to slow the progression of myopia in children between the ages of 8 and 12 years old at the initiation of treatment.
That matters to Andrew Neukirch, OD, of Carillon Vision Care, in Glenview, Illinois. He says, “The relationships my team and I cultivate with parents is built on trust. It’s my responsibility to protect their child’s eye health. Indications and all that’s behind them matters—a lot.” While doctors may choose to prescribe products off label, FDA approval comes with a specified indication, and only “after a rigorous process to ensure safety and efficacy. A physician’s clinical decision to use a medical device or drug off-label for its original indication should be evidence-based and well-thought-out for the best interest of the patient.”
DOCUMENT INFORMED CONSENT
Most experts note that eye care providers should obtain informed consent for any usage of off label products prescribed for treatments that have not received FDA approval. Dwight Barnes, OD, of Cary Family Eye Care in Cary, North Carolina, suggests “a brief document explaining the FDA approval status of available myopia management treatments in simple terms and print copies to provide to patients to facilitate discussion. Given the importance of offering this valuable service to patients, we should utilize all available treatments to slow myopia progression. This list of options includes on-label and off-label therapies. It is each doctor’s responsibility to evaluate which treatments offer the best safety and efficacy for each patient.”
At iSmart Vision Care, the Miami, Florida, office of Glenda Aleman, OD, she has created an informed consent document. Parents have to sign the document prior to starting myopia management treatment. The document includes a description of the treatment, the possible risks and side effects, the contraindications and the limitations. “The document also includes my commitment to them as a physician,” Dr. Aleman explains. “I will always make sure I’m available to see my patients in case of an emergency or that a qualified physician will be available to see them.”
Read more articles in the Getting Started with Myopia Management series. Be sure to check back as the series will be updated regularly with more content.
