DOT Spectacle Lenses for Nearsightedness
(ASH-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new type of glasses, called Diffusion Optics Technology (DOT) lenses, affects the eye's structure compared to regular glasses. The focus is on measuring changes in the eye's choroid, a layer rich in blood vessels. Children aged 8-14 with normal vision who can follow simple instructions might be suitable participants. The trial compares DOT lenses with regular lenses to identify any significant differences. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve vision care for children.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are using any medications that might affect the study results, like Atropine eye drops, you may not be eligible to participate.
What prior data suggests that these spectacle lenses are safe for use?
Research shows that Diffusion Optics Technology (DOT) glasses are safe for use. These glasses have been tested for controlling nearsightedness and have demonstrated positive safety outcomes. One study used DOT 0.2 lenses for four years and found them safe and effective in slowing the progression of nearsightedness. Another study reported that after one year, 65% of children using these lenses did not experience a significant decline in vision. These findings suggest that DOT lenses are well-tolerated and do not cause major side effects.12345
Why are researchers excited about this trial?
Researchers are excited about Diffusion Optics Technology (DOT) Pattern Spectacle Lenses because they offer a novel approach to managing nearsightedness. Unlike traditional corrective lenses that simply refocus light entering the eye, DOT lenses use a specialized pattern to diffuse light, potentially slowing the progression of nearsightedness itself. This innovative method stands out because it targets the underlying eye growth that leads to nearsightedness, rather than just correcting vision. This could represent a significant shift from standard lenses, which primarily focus on improving vision clarity without addressing the root cause of the condition.
What evidence suggests that DOT spectacle lenses are effective for nearsightedness?
This trial will compare Diffusion Optics Technology (DOT) Pattern Spectacle Lenses with Control Spectacle Lenses. Research has shown that DOT glasses can effectively slow the progression of nearsightedness, or myopia. Studies confirm their safety and long-term effectiveness, with clear benefits even after four years of use. The technology relies on a new method called contrast theory, which helps manage myopia. Both clinical trials and real-world experiences support the positive effects of these glasses, and they do not cause a rebound effect, meaning the benefits persist even after discontinuation. Overall, DOT glasses offer a promising option for controlling myopia.12356
Are You a Good Fit for This Trial?
This trial is for children aged 8-14 who can read or understand an assent document, have a parent or guardian to sign permission, and have near-sightedness within specific limits (+1.00D to -1.00D). They must be able to follow instructions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Diffusion Optics Technology (DOT) spectacle lenses or control lenses to measure their effect on choroidal thickness and choroidal vascularity index
Follow-up
Participants are monitored for changes in choroidal thickness and choroidal vascularity index at 30 and 60 minutes after baseline
What Are the Treatments Tested in This Trial?
Interventions
- Control Spectacle Lens
- Diffusion Optics Technology (DOT) Pattern Spectacle Lens
Find a Clinic Near You
Who Is Running the Clinical Trial?
SightGlass Vision, Inc.
Lead Sponsor
University of Waterloo
Collaborator