NCT04854447

Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.

Detailed description

A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Single-Vision Spectacles	Spectacle correction for myopia treatment

Timeline

• Start date: 2019-11-15
• Primary completion: 2021-06-28
• Completion: 2021-11-25
• First posted: 2021-04-22
• Last updated: 2021-12-22

Locations

1 site across 1 country: Greece