Full-Time Spectacle Wear for Eyeglasses

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Eyeglasses+1 MoreSpectacle wear support - Behavioral
Eligibility
12 - 35
All Sexes
What conditions do you have?
Select

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

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

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: Device

Trial 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.