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

NCT ID: NCT04854447

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-11-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Myopia

Keywords

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Myopia Spectacles Full-time correction Part-time correction Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

Part-time myopia correction with single-vision spectacles

Group Type EXPERIMENTAL

Single-Vision Spectacles

Intervention Type DEVICE

Spectacle correction for myopia treatment

Control Group

Full-time myopia correction with single-vision spectacles

Group Type ACTIVE_COMPARATOR

Single-Vision Spectacles

Intervention Type DEVICE

Spectacle correction for myopia treatment

Interventions

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Single-Vision Spectacles

Spectacle correction for myopia treatment

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Scholarships Foundation

UNKNOWN

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Asimina Mataftsi

Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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"Papageorgiou" General Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 25000870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27796670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31854025 (View on PubMed)

Other Identifiers

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2.68/27-02-2019

Identifier Type: -

Identifier Source: org_study_id