Eye care providers treating children with myopia must be familiar with the issues surrounding controlling – or not controlling – the myopia and the potential long-term consequences.
The International Myopia Institute, in one of a series of reports, issued industry guidelines and ethical considerations for myopia control.
Lead author Lyndon Jones, BSc, PhD, DSc, FCAHS, FCOptom, DipCLP, DipOrth, FAAO, FIACLE, FBCLA, told Primary Care Optometry News, “The concept behind this was to think very carefully about the fact that whether it be clinicians, regulators or industry, we’re dealing with a vulnerable population.”
He noted that for clinicians, the primary issue is “ensuring that they understand why they are recommending, or not recommending, myopia control. In order to do that you need to be aware of the literature with regards to, first of all, what happens if you do nothing? If you allow the patient in your chair to not undergo some form of myopia management, and they're a rapidly progressing myope, what are the potential long-term consequences?”
Previously, high myopia was considered an inconvenience due to the thick spectacles required for correction, Jones said.
The report refers to potential quality of life issues resulting from the use of vision correction for high prescriptions, such as introversion, anxiety, low self-esteem and less perceived attractiveness.
“But now we have really good epidemiological evidence that, certainly, once you get over -6.00 D, there’s a long-term risk of retinal detachment and myopic maculopathy that increases significantly,” Jones said. “It’s not even just those people over -6.00 D; even in people between -2.00 D and -6.00 D, for every diopter of myopia that occurs, your risk of long-term retinal disease increases.”
Another consideration is availability of evidence to support a myopia control strategy.
“They need to be up-to-date and cognizant of the literature about what’s available and also on-label vs. off-label,” Jones said. “Thirdly, what are the potential reductions in the progression of myopia that each of those procedures produce, and why would they choose one over the other?”
Clinicians must be aware of the risks and benefits of spectacles, soft contact lenses, orthokeratology and low-dose atropine, he said.
The authors of the report said the decision “represents the classical medical risk vs. benefit ratio.”
The belief that limiting myopia progression reduces the risk of vision-threatening disease is an “unverified premise,” and conclusive evidence will most likely not be available for decades.
However, if the assumption is proven correct, the benefits to society “could be substantial,” they said.
The authors noted the importance of clinicians providing appropriate informed consent for these off-label treatments and they provide a sample consent form in the appendix to the report.
Potential increased costs of treatment must be considered, they said, due to specialized equipment and extra clinic time.
Lastly, clinicians may be called upon to justify the professional rationale behind such treatments in the event of malpractice prosecution.
The authors provided five criteria for clinicians to consider when determining whether standards of practice are being met when prescribing off-label treatments: Is the drug or device approved? Has substantial peer review been conducted? Is it medically necessary? Is it nonexperimental? Has informed consent been provided, and has the patient agreed to it?
Jones concluded by saying that clinicians who are not comfortable using myopia control strategies should refer these children to someone who is. – Nancy Hemphill, ELS, FAAO
Disclosures: Jones reports financial relationships with Alcon, Allergan, Contamac, CooperVision, Essilor, GL Chemtec, Inflamax Research, Johnson & Johnson Vision, Menicon, Nature’s Way, Novartis, Ophtecs, PS Therapy, Safilens, Santen, Shire, SightGlass, TearLab, TearScience and Visioneering Technologies. Please see the full study for all other authors’ financial disclosures.