Research of the Correlation Between Metabolic Syndrome, R... | NCT01219478

Studies
Research of the Correlation Between Metabolic Syndrome, Retinal Thickness and Visual Acuity

NCT01219478

Sponsor

Taipei Medical University WanFang Hospital

Status

Completed

Last Update Posted

Dec 21, 2010Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Visual Acuity

Interventions

Not provided

Countries

Taiwan

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

Dec 2010

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 2009

Primary Completion Date

Not provided

Completion Date

Dec 2009Actual

First Submitted Date

Oct 10, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

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

Dec 19, 2010

Last Update Posted Date

Dec 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks (MRs) in patients without retinal lesion.

Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination, optical coherence tomography was performed to measure RT.

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

Not provided

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control		0 metabloil risk
1		1 metabloil risk
2		2 metabloil risk
3		3 metabloil risk

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

We enrolled the patients included age more than 60 years old, no positive finding during dilated fundus examination.

Exclusion Criteria:

The exclusion criteria were as followed:
- systemic disease that will affect visual acuity evaluation (for example: CVA), *opaque cornea and vitreous
- glaucoma
- uvietis and other clinically established ocular disease.
According to the LOCS III11, those who had nuclear opalescence, nuclear color more than grade 3 or any grade of cortical cataract and posterior subcapsular cataract were also eliminated.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients who were over 60 y/o were divided into four groups according to their MRs of hypertension, hyperlipidemia or hyperglyceremia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hui-Chun Ho	Taipei Medical University WanFang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University - WanFang Hospital		Taipei			Taiwan