Study Summary
This trial will compare the outcomes of two groups of children with astigmatism: those who are encouraged to wear glasses full-time, and those whose parents decide when they wear glasses.
Eligible Conditions
- Eyeglasses
- Astigmatism Bilateral
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: From the date of dispensing of the first pair of spectacles at the Spectacle Prescription Verification Visit through the date of the Developmental and Visual Assessment Visit, up to 30 months.
Month 30
Duration of spectacle wear
Day 1275
Adaptive Behavior
Cognitive Development
Language Development
Motor Development
Social-Emotional Development
Visual Acuity
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Full-Time Spectacle Wear
1 of 2
Ad-Lib Spectacle Wear
1 of 2
Active Control
172 Total Participants · 2 Treatment Groups
Primary Treatment: Full-Time Spectacle Wear · No Placebo Group · N/A
Full-Time Spectacle WearActiveComparator Group · 2 Interventions: Spectacle wear support, Spectacles · Intervention Types: Behavioral, Device
Ad-Lib Spectacle Wear
Device
ActiveComparator Group · 1 Intervention: Spectacles · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of dispensing of the first pair of spectacles at the spectacle prescription verification visit through the date of the developmental and visual assessment visit, up to 30 months.
Who is running the clinical trial?
National Eye Institute (NEI)NIH
517 Previous Clinical Trials
1,072,724 Total Patients Enrolled
University of ArizonaLead Sponsor
464 Previous Clinical Trials
157,311 Total Patients Enrolled
Erin M Harvey, Ph.D.Principal InvestigatorUniversity of Arizona
Joseph M Miller, M.D.Principal InvestigatorUniversity of Arizona
Eligibility Criteria
Age 12 - 35 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Parent is willing to commit to study visits every 180 days, to be contacted (phone, email, or text) for reports of spectacle wear, and to allow their child to wear the TheraMon® sensor on the spectacle headband.
Parent/guardian provision of informed consent form for Baseline/Eligibility Examination.
Parent/guardian must be willing to accept assignment to either group.
Parent/guardian provision of informed consent form for randomized SPEC Study.
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Conditions
Cancer Related
Treatments