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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854447
Other study ID # 2.68/27-02-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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