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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Single-Vision Spectacles
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, Spectacles, Full-time correction, Part-time correction, Childhood

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • "Papageorgiou" General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Group

Control Group

Arm Description

Part-time myopia correction with single-vision spectacles

Full-time myopia correction with single-vision spectacles

Outcomes

Primary Outcome Measures

Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.
Change in axial length (AL).

Secondary Outcome Measures

Change in choroidal thickness (ChT).
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.

Full Information

First Posted
April 18, 2021
Last Updated
December 7, 2021
Sponsor
Aristotle University Of Thessaloniki
Collaborators
State Scholarships Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04854447
Brief Title
Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
Official Title
Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
State Scholarships Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Spectacles, Full-time correction, Part-time correction, Childhood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Part-time myopia correction with single-vision spectacles
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Full-time myopia correction with single-vision spectacles
Intervention Type
Device
Intervention Name(s)
Single-Vision Spectacles
Intervention Description
Spectacle correction for myopia treatment
Primary Outcome Measure Information:
Title
Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.
Time Frame
Baseline to 6-months, and baseline to 12-months.
Title
Change in axial length (AL).
Time Frame
Baseline to 6-months, and baseline to 12-months.
Secondary Outcome Measure Information:
Title
Change in choroidal thickness (ChT).
Time Frame
Baseline to 6-months, and baseline to 12-months.
Title
Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study.
Description
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.
Time Frame
Baseline to 12-months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
"Papageorgiou" General Hospital
City
Thessaloníki
ZIP/Postal Code
56429
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25000870
Citation
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.
Results Reference
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PubMed Identifier
27796670
Citation
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.
Results Reference
background
PubMed Identifier
31854025
Citation
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.
Results Reference
background

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

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