Prevalence of Angle Closure in Caucasian Hyperopes | NCT00823706

Studies
Prevalence of Angle Closure in Caucasian Hyperopes

NCT00823706

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Apr 5, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Angle Closure Glaucoma

Interventions

Not provided

Countries

Israel

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

Jan 2009

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

Jan 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 15, 2009

First Submission Date that Met QC Criteria

Jan 15, 2009

First Posted Date

Jan 16, 2009Estimated

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

Apr 4, 2011

Last Update Posted Date

Apr 5, 2011Estimated

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

The primary purpose of this study is to assess the prevalence of asymptomatic chronic angle closure in high risk Caucasian individuals, namely those with hyperopia. A secondary purpose is to assess whether specific demographic or ocular-anatomic parameters in this population are associated with a higher risk for angle closure.

Detailed Description

Caucasian subjects aged > 40 years with hyperopia will undergo complete eye examination including subjective refraction and gonioscopy. In addition we will measure axial length, anterior chamber depth and lens thickness using ultrasound biometry.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of chronic angle closure in Caucasian hyperopes		1 year

Secondary Outcomes

Measure	Description	Time Frame
relative risk for chronic angle closure measured for demographic and ocular-anatomic parameters		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 40 years
Hyperopia greater then +1.00 D spherical equivalent

Exclusion Criteria:

Any identifiable eye disease or previous eye surgery that can affect the anatomy of the irido-corneal angle

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Caucasian subjects aged 40 years or more with hyperopia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yaniv barkana, md	Contact	97289779358		yanivbarkana@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofe Medical Center Ophthalmology Department	Recruiting	Ẕerifin		70300	Israel