The most significant news regarding orthokeratology (ortho-k) in the last year is that, contrary to what we reported in last year’s GP Annual Report,4 FDA clearance of the modality for myopia control will not occur anytime soon. The same is true for soft multifocal lenses. Andre reported that—like extended wear contact lenses—both overnight ortho-k and soft lenses for myopia control are in the Class III, Significant Risk category.16
He also discussed the FDA workshop on Sept. 30, 2016, in which experts discussed what it would take for FDA clearance of myopia control lenses. In particular, the workshop covered what questions would need to be answered and what criteria would need to be established in a long-term study to evaluate myopia control. It was decided that such a study would need to be four years in length (three years treatment and one year regression) with children from 7 to 12 years of age. The experimental group would need to have approximately 225 subjects, and the control group would need to consist of 175 subjects. Therefore, whether it is an overnight ortho-k design or a multifocal soft lens, it was predicted that initial FDA approval may be a five- to seven-year process.
Figure 3 shows the readership survey results to the question regarding the use of corneal reshaping/overnight ortho-k lens designs (if applicable) over the past 12 months. With more than 50% of respondents not having incorporated this modality into their practice, of those who have, only 4% indicated that their use of this modality has decreased. Figure 4supports the fact that peripheral-plus-power soft lenses appear to be becoming more of a common option for myopia control, with more than 10% of respondents indicating that this is the preference in their practice as compared to overnight ortho-k. Interestingly, atropine (in some form) was used by more than 23% of the readership for the purpose of myopia control.
Figure 3. The use of corneal reshaping/overnight orthokeratology lens designs (if applicable) in your practice in the past 12 months has:
Figure 4. Your myopia control program includes:
About Dr. Bennett
Dr. Bennett is assistant dean for Student Services and Alumni Relations at the University of Missouri-St. Louis College of Optometry and is executive director of the GP Lens Institute. He is also clinical features editor for Contact Lens Spectrum. You can reach him at firstname.lastname@example.org.