NCT05348369

Brief Summary

Orthokeratology lens is an effective method for myopia control. This study analyzed the relationship between the relative corneal refractive power shift and change of axial length in adolescents with orthokeratology lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

April 20, 2022

Last Update Submit

April 20, 2022

Conditions

MyopiaOrthokeratology

Keywords

MyopiaOrthokeratologyAxial length

Outcome Measures

Primary Outcomes (1)

  • The change of axial length

    The axial length was measured by AL-scan, its expressed in mm

    The change of baseline and 1years

Secondary Outcomes (1)

  • Relative corneal refractive power shift(RCRPS)

    up to 1 year

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Myopia children with orthokeratology lens and complete follow-up.

You may qualify if:

  • age from 8 to 15years
  • spherical equivalent(SE) was range from -1.00D to -5.00D
  • conform to the standard of wearing orthokeratology lens

You may not qualify if:

  • ocular diseases and systemic diseases
  • visual acuity was less than 20/20
  • unable to follow visitors on time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (2)

  • Vincent SJ, Cho P, Chan KY, Fadel D, Ghorbani-Mojarrad N, Gonzalez-Meijome JM, Johnson L, Kang P, Michaud L, Simard P, Jones L. CLEAR - Orthokeratology. Cont Lens Anterior Eye. 2021 Apr;44(2):240-269. doi: 10.1016/j.clae.2021.02.003. Epub 2021 Mar 25.

    PMID: 33775379BACKGROUND

  • Guo B, Cheung SW, Kojima R, Cho P. One-year results of the Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study: a prospective randomised clinical trial. Ophthalmic Physiol Opt. 2021 Jul;41(4):702-714. doi: 10.1111/opo.12834. Epub 2021 May 15.

    PMID: 33991112BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 27, 2022

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)