The Effect of Treatment Zone Decentration on Axial Length... | NCT05365373

Studies
The Effect of Treatment Zone Decentration on Axial Length Elongation After Orthokeratology

NCT05365373

Sponsor

Tianjin Eye Hospital

Status

Completed

Last Update Posted

May 9, 2022Actual

Enrollment

251Actual

Phase

Not provided

Conditions

Myopia
Orthokeratology

Interventions

Not provided

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 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

May 4, 2022

First Submission Date that Met QC Criteria

May 4, 2022

First Posted Date

May 9, 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

May 4, 2022

Last Update Posted Date

May 9, 2022Actual

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

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.

Detailed Description

Orthokeratology lens is an effective method for myopia control. This study aimed to investigate the effects of treatment zone decentration on axial length elongation in adolescents with orthokeratology lens in 1 year. Other factors that may affect axial growth were also analyzed.

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

251Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
the decentration magnitudes of the treatment zone	The value of decentration magnitudes was obtained and calculated from a corneal topography	up to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age from 8 to 15years
spherical equivalent(SE) was range from -1.00D to -5.00D
conform to the standard of wearing orthokeratology lens

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Myopia children with orthokeratology lens and complete follow-up.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Eye Hospital		Tianjin	Tianjin Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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