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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854447
• Other study ID #: 2.68/27-02-2019
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: November 25, 2021

Study information

• Verified date: December 2021
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 25, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Single-Vision Spectacles
Spectacle correction for myopia treatment

Locations

Country	Name	City	State
Greece	"Papageorgiou" General Hospital	Thessaloníki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	State Scholarships Foundation

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.		Baseline to 6-months, and baseline to 12-months.
Primary	Change in axial length (AL).		Baseline to 6-months, and baseline to 12-months.
Secondary	Change in choroidal thickness (ChT).		Baseline to 6-months, and baseline to 12-months.
Secondary	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.