Responding to Short-Sightedness
An open letter to The Ophthalmologist
Mark A. Bullimore | | 4 min read | Opinion
I appreciate the recent article in The Ophthalmologist shining a light on myopia, the potential for slowing its progression, and thus reducing the risks of eye disease and visual impairment later in life (1). It is useful to see conflicting opinions amongst the contributors – something to be expected in an emerging field.
Three of the experts are clearly still riding the 0.01% atropine bandwagon, although one states that “0.01 percent atropine eye drops are effective in non-Asian children” while also concluding that “low-dose atropine 0.01 percent was not as effective in reducing axial length progression” as “highly aspheric lenslets (HAL), MiSight contact lenses, low dose atropine 0.05 percent, Biofinity +2.50 D lenses, Defocus Incorporated Multiple Segments (DIMS) eyeglasses, and orthokeratology lenses.” (2)
My primary concern with the article is the disrespect shown to the eye care industry, which is driving the science of myopia control. One contributor makes a comment regarding “potential conflicts of interest” when it comes to “optical solutions.” In their defense, they could be referring to manufacturers, prescribers, or both…
Another contributor states that opticians in their country “market different contact lenses as correcting peripheral hyperopic defocus, but again comprehensive data is lacking” and that “ophthalmologists have a skeptical attitude to these lenses due to somewhat questionable scientific evidence.” He proceeds to selectively review portions of the literature, while acknowledging, but grossly overstating, the effect of age on rate of progression. He also states that “[o]ther studies on the efficacy of MiSight are by no means conclusive due to high dropout rates or other flaws in methodologies.”
Absent from the discussion are the results of the pivotal three-year randomized clinical trial (3) of the MiSight lens that resulted in its approval by the US Food and Drug Administration (FDA) (4). Almost four years later, MiSight remains the only device or drug approved for the slowing of myopia progression in the US. The three-year trial showed that the lens slowed myopia by 0.73 D while reduced axial elongation by 0.32 mm (3). This met a very high bar set by the FDA and approval would never have been granted were the results “by no means conclusive” with “flaws in methodologies.”
Implicit in the comments is a blatant distrust of research funded by the eye care industry, although one assumes that they happily use surgical and diagnostic devices in their practice, while prescribing drugs and therapies to their patients – all developed by the eye care industry. They also appear to be ignorant that these FDA clinical trials are usually conducted at academic institutions and that the FDA conducts inspections to determine if the clinical investigators are conducting clinical studies in compliance with applicable statutory and regulatory requirements (5). In short, the level of rigor and oversight associated with industry-sponsored clinical trials usually far exceeds that of individuals and groups of investigators.
Returning to 0.01% atropine, a three-year randomized clinical trial was just published that could lead to its approval by FDA (6,7). The trial showed 0.24 D slowing of progression and 0.13 mm slowing of axial elongation (6). I wonder whether the above criticism will be applied to these results with the same vigor or if the contributor will prefer to cite five-year studies conducted by independent clinicians in Europe and their fantastical findings (8, 9).
In closing, I am glad that opinions like those expressed in this recent article can be aired in The Ophthalmologist. At the same time, the publication is supported by the eye care industry and the herculean efforts needed to bring products to our patients and the level of rigor underlying these endeavors should be celebrated and not disparaged.
- “Shutting Down Short-Sightedness,” The Ophthalmologist, June/July 2023.
- C Lanca et al., “A Topical Review: Studies on Management of Myopia Progression from 2019 to 2021,” Optom Vis Sci, 100, 23 (2023).
- P Chamberlain et al., “A Three-year Randomized Clinical Trial of MiSight Lenses for Myopia Control,” Optom Vis Sci, 96, 556 (2019).
- US Food and Drug Administration, MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear.
- US Food and Drug Administration, Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators.
- K Zadnik et al., “Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial, “JAMA Ophthalmology, June 2023. DOI:10.1001/jamaophthalmol.2023.2097
- “Vyluma announces FDA acceptance of NDA for NVK002 for treatment of pediatric myopia, Ophthalmology Times, June 6, 2023.
- M Diaz-Llopis, “Superdiluted atropine at 0.01% reduces progression in children and adolescents. A 5-year study of safety and effectiveness,” Arch Soc Esp Oftalmol, 93, 182 (2018).
- M Moriche-Carretero et al., “Five-year results of atropine 0.01% efficacy in the myopia control in a European population,” Br J Ophthalmol (2023). http://dx.doi.org/10.1136/bjo-2022-322808