Choroidal Thickness Association With Primary Angle Closure | NCT03050073

Studies
Choroidal Thickness Association With Primary Angle Closure

NCT03050073

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Aug 10, 2018Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Choroidal Thickness

Interventions

Not provided

Countries

France

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

Aug 2018

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 18, 2016Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Feb 7, 2017

First Submission Date that Met QC Criteria

Feb 8, 2017

First Posted Date

Feb 10, 2017Actual

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

Aug 9, 2018

Last Update Posted Date

Aug 10, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

A chinese study shows that chinese population eyes with a primary angle closure have a greater choroidal thickness than normal eyes.The increase of choroidal thickness would be associated to this primary angle closure.

Detailed Description

Usual ophtalmic consultation for glaucoma with primary angle closure

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of choroidal thickness measurement by Imaging of the fundus oculi (OCT swept source)		Day 1 Day 30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Primary angle closure confirmed by gonioscopy
interpretable images for choroidal thickness measure
interpretable images by Ultra Bio Microscopy (UBM)

Exclusion Criteria:

Acute crisis for angle closure
Rethinopathy (diabetic or hypertensive)
Histories of intra-eye surgery
Great myopia
Hypermetropia
retinal pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Every patient consulting for glaucoma or not with primary angle closure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hélène BEAUSSIER, Pharm-D	CRC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided