Biometric Factors Changes Caused by Myopia Orthokeratolog... | NCT05433259

Studies
Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

NCT05433259

Sponsor

Wenzhou Medical University

Status

Unknown status

Last Update Posted

Jun 30, 2022Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Contact Lenses

Interventions

Overnight orthokeratology

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Mar 12, 2022Actual

Completion Date

Nov 1, 2023Estimated

First Submitted Date

Jun 21, 2022

First Submission Date that Met QC Criteria

Jun 21, 2022

First Posted Date

Jun 27, 2022Actual

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

Jun 25, 2022

Last Update Posted Date

Jun 30, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Wenzhou Medical UniversityOTHER

Collaborators

Not provided

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

Subjects fit with VST or CRT type lens are reviewed 1 day to 2 year after first wearing the lens. Ocular examinations were performed, including slit-lamp biomicroscope, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), corneal topography (Medmont E300W, Medmont Pty Ltd, Melbourne, Australia), corneal refractive power (autorefractometer, KR880, Topcon, JAPAN), corneal epithelial thickness (Optical Coherence Tomography, RTVue-XR), axial length using IOL-Master 700 (Carl Zeiss Meditec AG). To investigate corneal and retina changes caused by overnight OK lens.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT type lens	Experimental	Subjects fitted with CRT type lenses	Device: Overnight orthokeratology
VST type lens	Experimental	Subjects fitted with VST type lenses	Device: Overnight orthokeratology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Overnight orthokeratology	Device	Subjects require to wear the lenses every night, with a recommended time of 6-8 hours.	CRT type lens VST type lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of Corneal Epithelium	All epithelial thickness and treatment zone area record by baseline and follow up examination.	up to 1 day, 1 week,1 month

Secondary Outcomes

Measure	Description	Time Frame
Axial length	Axial length growth after lens wear	up to 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal subjects without any history of ocular surgeries or diseases (except for refractive errors) or systemic diseases that might affect contact lens wearing. The spherical error between -1.0 and -5.0 D, cylindrical error of at most 2.0 D, and a corrected distance visual acuity of 20/20 or better.

Exclusion Criteria:

Subjects who had previously worn contact lens, were also excluded

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of Wenzhou Medical College		Wenzhou	Zhejiang		China