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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Single-Vision Spectacles

• Registration Number: NCT04854447
• Lead Sponsor: Aristotle University Of Thessaloniki

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 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.

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-22
• Primary Completion: 2021-06-28
• Study Completion: 2021-11-25
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Single-Vision Spectacles	Part-time myopia correction with single-vision spectacles
Control Group	Single-Vision Spectacles	Full-time myopia correction with single-vision spectacles

Primary Outcome Measures

Name	Time	Method
Change in axial length (AL).	Baseline to 6-months, and baseline to 12-months.
Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.	Baseline to 6-months, and baseline to 12-months.

Secondary Outcome Measures

Name	Time	Method
Change in choroidal thickness (ChT).	Baseline to 6-months, and baseline to 12-months.
Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study.	Baseline to 12-months.	This questionnaire is formed by the researchers participating in this study and is aimed at providing a qualitative assessment of the subjective tolerance of included children wearing spectacles. It incorporates 6 questions and is not based on a scale.

Trial Locations

Locations (1)

"Papageorgiou" General Hospital; 🇬🇷 Thessaloníki, Greece