NCT04854447

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

April 18, 2021

Last Update Submit

December 7, 2021

Conditions

Myopia

Keywords

MyopiaSpectaclesFull-time correctionPart-time correctionChildhood

Outcome Measures

Primary Outcomes (2)

  • Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.

    Baseline to 6-months, and baseline to 12-months.

  • Change in axial length (AL).

    Baseline to 6-months, and baseline to 12-months.

Secondary Outcomes (2)

  • Change in choroidal thickness (ChT).

    Baseline to 6-months, and baseline to 12-months.

  • Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study.

    Baseline to 12-months.

Study Arms (2)

Study Group

EXPERIMENTAL

Part-time myopia correction with single-vision spectacles

Device: Single-Vision Spectacles

Control Group

ACTIVE COMPARATOR

Full-time myopia correction with single-vision spectacles

Device: Single-Vision Spectacles

Interventions

Single-Vision SpectaclesDEVICE

Spectacle correction for myopia treatment

Control GroupStudy Group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Papageorgiou" General Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (3)

  • 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.

    PMID: 25000870BACKGROUND

  • 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.

    PMID: 27796670BACKGROUND

  • 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.

    PMID: 31854025BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Study Record Dates

First Submitted

April 18, 2021

First Posted

April 22, 2021

Study Start

November 15, 2019

Primary Completion

June 28, 2021

Study Completion

November 25, 2021

Last Updated

December 22, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)