Spectacle lens9/4/2023 This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually. Eyeglasses are a simple, safe way to correct vision problems caused by presbyopia. After 24-months of usage, subjects who wore DOT lenses full-time had less myopia progression than control subjects. Treatment options include wearing corrective eyeglasses (spectacle lenses) or contact lenses, undergoing refractive surgery, or getting lens implants for presbyopia. The difference in means (Test 1 minus Control) for change from baseline of AL (-0.21 mm) and SER (0.52 D) were statistically significant (p<0.0001).ĭOT spectacle lenses were designed to reduce retinal contrast to slow the progression of myopia. If you have a new prescription for glasses, you can simply order a replacement eyeglass lens. The mean change from baseline in SER after 24-months of usage was -0.36 ± 0.54, -0.48 ± 0.85, and -0.88 ± 0.77 D for Test 1, Test 2, and Control, respectively. After 24-months, the mean (± SD) change from baseline in AL was 0.33 ± 0.23, 0.34 ± 0.39, and 0.53 ± 0.33 mm for Test 1, Test 2, and Control respectively. Axial length (AL) and cycloplegic autorefraction (SER) were measured at baseline and annual follow-up visits, now through 24-months.Īpproximately two-thirds of study subjects (61, 45, and 66 in Test 1, Test 2, and Control, respectively) met criteria for “full-time wearers”. “Full time wearers” were defined as those subjects whose parents reported that they did not remove the study spectacles for near vision activities. Subjects were asked to wear the study spectacles constantly, except for activities in which standard spectacle wear would be inappropriate, such as contact sports and swimming. Two hundred and fifty-six (256) eligible myopic subjects were randomized and dispensed spectacles at 14 clinical sites in North America. Novel spectacle lenses (DOT lenses) were developed to evaluate this hypothesis, and a multi-center, double-masked, randomized, controlled clinical trial was initiated.ĬYPRESS (NCT03623074) evaluated two investigational spectacle lenses (Test 1, Test 2) designed to slightly reduce contrast compared to control spectacle lenses for the ability to reduce myopia progression in children 6-10 years of age over a period of 3 years. This hypothesis predicted that reducing the contrast of images on the retina could slow myopia progression. The discovery that polymorphisms at the myopia genetic locus, MYP1, are associated with splicing-defective cone opsin genes ( OPN1LW and OPN1MW) led to the hypothesis that contrast signaling in the retina plays an important role in myopia development and progression. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.New therapies are urgently needed to slow or stop myopia progression in children, and therefore reduce the risk of long-term, sight-threatening complications from myopia. Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The information on this page is current as of Mar 28, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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