Status:
COMPLETED
Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
State Scholarships Foundation
Conditions:
Myopia
Eligibility:
All Genders
4-16 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Age 4 to 16 years old at the time of enrollment.
- Best-corrected visual acuity (BCVA) LogMAR 0.1 or better, in each eye.
- Cycloplegic Autorefraction: Myopia, SER between -0.50D and -6.00D, in each eye. Astigmatism less than or equal to 1.50D, in each eye. Anisometropia less than or equal to 1.50D between the two eyes.
- Absence of any ocular or systemic condition that could influence refractive development, other than myopia.
- Eagerness to participate in this study and receive myopia treatment in a randomized fashion. Availability for at least 1-year follow-up. Subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject.
Exclusion
- Presence of strabismus.
- Presence of amblyopia.
- Prematurity (gestational age less than 37 weeks).
- Presence of an ocular condition affecting refraction (ie. cataract, dislocated lens).
- Presence of a systemic condition affecting refraction (ie. Down syndrome, Marfan syndrome).
- Allergy to cyclopentolate. Severe ocular or systemic allergies.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04854447
Start Date
November 15 2019
End Date
November 25 2021
Last Update
December 22 2021
Active Locations (1)
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1
"Papageorgiou" General Hospital
Thessaloniki, Greece, 56429