Investigating the Safety and Effect of Overnight Orthoker... | NCT04910451

Studies
Investigating the Safety and Effect of Overnight Orthokeratology and Its Influencing Factors

NCT04910451

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jun 2, 2021Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Myopia

Interventions

No Intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jul 1, 2022Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

May 31, 2021

First Posted Date

Jun 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2021

Last Update Posted Date

Jun 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Patients who were successfully prescribed with orthokeratology lenses in Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine were enrolled in the study. Our study used two different methods to collect data. For complications and effect of orthokeratology information, data were collected by a retrospective survey. A questionnaire was used to collect influencing factors of safety and effect of orthokeratology.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
axial length	changes in axial length	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

myopia patients who were using orthokeratology for myopia control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhiwen Bian, doctor	Contact	+86 13588083734		bianzhiwen87@163.com
Hailing Ni, doctor	Contact	+86-571-87783897		2101092@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Zhiwen Bian, doctor	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided