NCT03919396

Brief Summary

This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

April 16, 2019

Last Update Submit

February 27, 2023

Conditions

MyopiaOrthokeratology

Keywords

MyopiaMyopia ControlOrthokeratologyElectroretinogramMultifocal Electroretinogram

Outcome Measures

Primary Outcomes (1)

  • Subjective Refraction

    Refractive Error ( in Diopter )

    up to 24 months

Secondary Outcomes (1)

  • Axial Length

    up to 24 months

Study Arms (2)

OrthoK (orthokeratology)

EXPERIMENTAL

Group wearing Breath-O corrected orthokeratology lenses for 2 years

Device: Breath-O orthokeratology lenses

SV Lenses (Single vision)

NO INTERVENTION

Group wearing spectacle with single vision lenses for 2 years

Interventions

Breath-O orthokeratology lensesDEVICE

Specially designed rigid gas permeable lenses which 1. reshapes corneal profile for myopia control 2. has higher elasticity compared to traditional lens material.

OrthoK (orthokeratology)

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Refractive error: Spherical: -1.00D to -4.00D; Cylindrical: half of Sph (against-the-rule Astig.: less than -0.75D)
  • Best corrected Visual acuity: monocular ETDRS 0.1 or better

You may not qualify if:

  • Ocular abnormality
  • Contra-indicated for overnight orthokeratology lens wear
  • History of refractive surgery
  • Systemic diseases
  • History of orthokeratology lenses wearing or other myopia control methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Optometry, Hong Kong Polytechnic University

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Henry HL Chan, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 18, 2019

Study Start

April 1, 2019

Primary Completion

October 31, 2019

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)