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

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Single-Vision Spectacles

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece, 56429
    • "Papageorgiou" General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Part-time myopia correction with single-vision spectacles	Device: Single-Vision Spectacles; Spectacle correction for myopia treatment
Active Comparator: Control Group; Full-time myopia correction with single-vision spectacles	Device: Single-Vision Spectacles; Spectacle correction for myopia treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 12-months.

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: State Scholarships Foundation

Publications and helpful links

General Publications

• Vasudevan B, Esposito C, Peterson C, Coronado C, Ciuffreda KJ. Under-correction of human myopia--is it myopigenic?: a retrospective analysis of clinical refraction data. J Optom. 2014 Jul-Sep;7(3):147-52. doi: 10.1016/j.optom.2013.12.007. Epub 2014 May 10.
• Sun YY, Li SM, Li SY, Kang MT, Liu LR, Meng B, Zhang FJ, Millodot M, Wang N. Effect of uncorrection versus full correction on myopia progression in 12-year-old children. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):189-195. doi: 10.1007/s00417-016-3529-1. Epub 2016 Oct 29.
• Logan NS, Wolffsohn JS. Role of un-correction, under-correction and over-correction of myopia as a strategy for slowing myopic progression. Clin Exp Optom. 2020 Mar;103(2):133-137. doi: 10.1111/cxo.12978. Epub 2019 Dec 18.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Childhood; Myopia; Spectacles; Full-time correction; Part-time correction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2.68/27-02-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No