Age-related Changes of Crystalline Lens Tilt and Decentra... | NCT04487795

Studies
Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study

NCT04487795

Sponsor

Yune Zhao

Status

Completed

Last Update Posted

Jul 27, 2020Actual

Enrollment

230Actual

Phase

Not provided

Conditions

Crystalline Cataract
Lens; Anomaly

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

Jul 2020

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

Apr 15, 2020Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

May 17, 2020Actual

First Submitted Date

Jul 23, 2020

First Submission Date that Met QC Criteria

Jul 23, 2020

First Posted Date

Jul 27, 2020Actual

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

Jul 23, 2020

Last Update Posted Date

Jul 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Yune ZhaoOTHER

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

230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the measurement. All the measurements were performed under non-mydriatic conditions in a dim examination room using the CASIA2 swept-source AS-OCT system.

Detailed Description

Not provided

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

230Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
crystalline lens tilt	magnitude and direction of crystalline lens lilt	2020.4.30
crystalline lens decentration	magnitude and direction of crystalline lens decentration	2020.4.30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria：

healthy volunteers and patients with age-related cataract

Exclusion Criteria:

aphakia or pseudophakia
any other ocular diseases with the exception of senile cataract
any history of ocular surgery
fixation difficulties caused by any reasons

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou Medical University

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology and Optometry Hospital		Wenzhou	Zhejiang	325027	China

Condition Browse Module

MeSH Terms

ID	Term
D000013	Congenital Abnormalities

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
under 18 years old
18-40 years old
41-60 years old
over 60 years old