NCT04910451

Brief Summary

To investigate the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors in China

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 31, 2021

Last Update Submit

May 31, 2021

Conditions

Keywords

orthokeratologymyopia control

Outcome Measures

Primary Outcomes (1)

  • axial length

    changes in axial length

    1 year

Interventions

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

myopia patients who were using orthokeratology for myopia control

You may qualify if:

  • Patients who were successfully prescribed with ortho-k lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine

You may not qualify if:

  • Patients who have ceased wearing orthokeratology or who were using other methods of myopia control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Zhiwen Bian, doctor

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiwen Bian, doctor

CONTACT

Hailing Ni, doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 2, 2021

Study Start

July 1, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations