Medical device company SightGlass Vision, Inc. announced earlier this month new data assessing the tolerability of three novel lenses designed to control nearsightedness in children. These three iterations were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting, held April 28 to May 2, 2019 in Vancouver, British Columbia.
Data presented at ARVO 2019 were from WALNUT, the Company's prospective, randomized, subject-masked, three-arm clinical study of 21 healthy myopic (-1.00 to -4.00 DS) children aged six-to-12 years old who were habitual spectacle wearers. Study participants were randomized to one of three lens designs for two weeks. Lenses were designed to modulate contrast in the periphery of the visual field at three different levels. The primary outcome variables were distance visual acuity, contrast sensitivity, and subjective responses of acceptability assessed using a questionnaire. Other outcome variables included a parent questionnaire, near visual acuity, and axial length measurements.
Results showed that all three lens designs were well tolerated. In addition, high-contrast distance visual acuity in both high and low room illumination were at high levels, not different to refraction acuity levels (p>0.05). There were no differences between any of the lens designs for high-contrast, high-illumination distance and near acuity, high-contrast, low-illumination distance acuity or contrast sensitivity. Results from the subject questionnaire indicated that the study participants' experience with lens designs 1 and 2 were similar to each other and to their habitual spectacles. By some measures, study participants preferred their habitual spectacles to lens design 3. Of note, all three lens designs showed a trend toward reduction in axial length over the two weeks of lens wear with lens design 1 reaching statistical significance in both eyes (p<0.05). The axial length reductions noted in WALNUT are consistent with a therapeutic effect of slowing myopia progression.
Results from WALNUT were used to determine the two spectacle lens designs now being tested in another pivotal trial CYPRESS. CYPRESS will evaluate the safety and efficacy of our novel lenses compared to standard spectacles to reduce the rate of progression of myopia in children aged six-to-10 years old. SightGlass expects to report initial results from the CYPRESS study in 2020, followed by additional data with longer-term follow up.
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News source: https://www.prnewswire.com/news-releases/sightglass-vision-presents-clinical-trial-data-from-novel-lenses-to-control-nearsightedness-at-the-association-for-research-in-vision-and-ophthalmology-arvo-annual-meeting-300840254.html
Source: SightGlass Vision