NCT03050073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

February 7, 2017

Last Update Submit

August 9, 2018

Conditions

Choroidal Thickness

Outcome Measures

Primary Outcomes (1)

  • change of choroidal thickness measurement by Imaging of the fundus oculi (OCT swept source)

    Day 1 Day 30

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Every patient consulting for glaucoma or not with primary angle closure

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Hélène BEAUSSIER, Pharm-D

    CRC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 10, 2017

Study Start

April 18, 2016

Primary Completion

June 30, 2016

Study Completion

December 31, 2016

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

FR(1)