NCT05365373

Brief Summary

Orthokeratology lens is an effective method for myopia control. This study analyzed the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

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

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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

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 4, 2022

Last Update Submit

May 4, 2022

Conditions

MyopiaOrthokeratology

Keywords

MyopiaOrthokeratologyAxial lengthDecentration

Outcome Measures

Primary Outcomes (1)

  • The change of axial length

    The axial length was measured by IOL-Master 500, its expressed in mm

    The change of baseline、6 months and 12months

Secondary Outcomes (1)

  • the decentration magnitudes of the treatment zone

    up to 1 year

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
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
  • stop wearing for ≥7 days for any reason during the follow-up period
  • keratoconjunctival complications, glare, diplopia, or any other symptoms during follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

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

May 4, 2022

First Posted

May 9, 2022

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)