Choroidal ThicknessNCT03050073
Choroidal Thickness Association With Primary Angle Closure
An observational study of Choroidal Thickness, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Thickness
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2016to 31 Dec 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient consulting for glaucoma or not with primary angle closure
Who may be able to join
- Age >18 years
- Primary angle closure confirmed by gonioscopy
- interpretable images for choroidal thickness measure
- interpretable images by Ultra Bio Microscopy (UBM)
Who cannot join
- Acute crisis for angle closure
- Rethinopathy (diabetic or hypertensive)
- Histories of intra-eye surgery
- Great myopia
- Hypermetropia
- retinal pathology
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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.
Read the detailed description
Usual ophtalmic consultation for glaucoma with primary angle closure
- Conditions
- Choroidal Thickness
What is being measured
The primary outcome is the main question the study is designed to answer.
change of choroidal thickness measurement by Imaging of the fundus oculi (OCT swept source)
Measured: Day 1 Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start18 Apr 2016
- Primary completion30 Jun 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BEAUSSIER, Pharm-D, Study director, CRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050073
- Sponsor's protocol ID
- IRIS
- Status last verified
- Aug 2018
- First submitted
- 7 Feb 2017
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Thickness Association With Primary Angle Closure
- ClinicalTrials.gov ID
- NCT03050073
- Acronym / sponsor ID
- IRIS
- Conditions
- Choroidal Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient consulting for glaucoma or not with primary angle closure
Key inclusion criteria (4 listed)
- Age >18 years
- Primary angle closure confirmed by gonioscopy
- interpretable images for choroidal thickness measure
- interpretable images by Ultra Bio Microscopy (UBM)
Key exclusion criteria (6 listed)
- Acute crisis for angle closure
- Rethinopathy (diabetic or hypertensive)
- Histories of intra-eye surgery
- Great myopia
- Hypermetropia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of choroidal thickness measurement by Imaging of the fundus oculi (OCT swept source)
Time frame: Day 1 Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène BEAUSSIER, Pharm-D study director
CRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Thickness, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of choroidal thickness measurement by Imaging of the fundus oculi (OCT swept source) (time frame: Day 1 Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.