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

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ClinicalTrials.gov Identifier: NCT04854447
Recruitment Status : Completed
First Posted : April 22, 2021
Last Update Posted : December 22, 2021
Sponsor:
Collaborator:
State Scholarships Foundation
Information provided by (Responsible Party):
Asimina Mataftsi, Aristotle University Of Thessaloniki

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

Condition or disease Intervention/treatment Phase
Myopia Device: Single-Vision Spectacles Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : June 28, 2021
Actual Study Completion Date : November 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction. [ Time Frame: Baseline to 6-months, and baseline to 12-months. ]
  2. Change in axial length (AL). [ Time Frame: Baseline to 6-months, and baseline to 12-months. ]

Secondary Outcome Measures :
  1. Change in choroidal thickness (ChT). [ Time Frame: Baseline to 6-months, and baseline to 12-months. ]
  2. Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854447


Locations
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Greece
"Papageorgiou" General Hospital
Thessaloníki, Greece, 56429
Sponsors and Collaborators
Aristotle University Of Thessaloniki
State Scholarships Foundation
More Information
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Publications:

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Responsible Party: Asimina Mataftsi, Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04854447    
Other Study ID Numbers: 2.68/27-02-2019
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asimina Mataftsi, Aristotle University Of Thessaloniki:
Myopia
Spectacles
Full-time correction
Part-time correction
Childhood
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases