NCT05635526

Brief Summary

The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

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

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

December 2, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

November 22, 2022

Last Update Submit

November 22, 2022

Conditions

MyopiaOrthokeratology

Keywords

Myopia prevention and controlOrthokeratologyDynamic corneal response

Outcome Measures

Primary Outcomes (1)

  • The change of dynamic corneal response (DCR)

    The axial length was measured by Corvis ST

    The change of baseline and 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months

Secondary Outcomes (1)

  • The change of axial length

    The change of baseline and 6 months

Study Arms (3)

1

8-12 years old

2

13-16 years old

3

over 16 years old

Eligibility Criteria

Age8 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Myopia with orthokeratology lens and complete follow-up.

You may qualify if:

  • age from 8 to 40 years old
  • 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)

Tiajin 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

November 22, 2022

First Posted

December 2, 2022

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

October 1, 2022

Last Updated

December 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)