GlaucomaNCT02757677
Evaluation of Blood Flow Characteristics in Glaucoma Using Optical Coherence Tomography Angiography (OCT-A).
An observational study of Glaucoma, run by Swiss Vision Network at 1 site in Switzerland.
Trial summary
The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based Angiography (OCT-A) softwares in the diagnosis and management of glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Optical Coherence Tomography based Angiography
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Dec 2015to 31 Dec 2019
- 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: All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center.
Who may be able to join
- Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma.
- Documented glaucomatous visual field damage (in the previous 12 months with mean defect (MD) > 2.0 dB)
- Structural and/or functional glaucomatous damage
- Have given written informed consent, prior to any investigational procedures
Who cannot join
- Patients with allergy to corneal anesthetic
- Patients not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Other diseases that may cause visual field loss or optic disc abnormalities
- Refractive error of > +3.00D or < -7.00D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional, Prospective, Observational Study to Evaluate Blood Flow Characteristics in Glaucoma Patients Using Optical Coherence Tomography Based Angiography (OCT-A).
The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.
- Conditions
- Glaucoma
- Being tested
- Optical Coherence Tomography based Angiography
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography based AngiographyDevice
A contrast-free, noninvasive technology to identify blood vessels in the eye
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal arm | Evaluate optic nerve head blood flow using the new OCT-A software in surgically and medically treated glaucoma patients and in different types of glaucoma Receives: Device: Optical Coherence Tomography based Angiography | |
| 24-h Intraocular pressure (IOP) arm | Evaluate the correlation between circadian IOP changes and optic nerve head blood flow using the new OCT-A software Receives: Device: Optical Coherence Tomography based Angiography | |
| Surgery arm | Evaluate blood flow using the new OCT-A software in surgically treated glaucoma patients Receives: Device: Optical Coherence Tomography based Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular and optic nerve head bloodflow, as measured by OCT-A macular and optic nerve head vessel density (%)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start31 Dec 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Difficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Vision Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kaweh Mansouri, Swiss Vision Network
- Investigators
- Kaweh Mansouri, MD, Principal investigator, Glaucoma center, Montchoisi clinic, Swiss vision network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757677
- Sponsor's protocol ID
- GR-02
- Status last verified
- May 2022
- First submitted
- 13 Apr 2016
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Prospective, Observational Study to Evaluate Blood Flow Characteristics in Glaucoma Patients Using Optical Coherence Tomography Based Angiography (OCT-A).
- ClinicalTrials.gov ID
- NCT02757677
- Acronym / sponsor ID
- GR-02
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Swiss Vision NetworkUniversity, hospital or other
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Longitudinal arm | – | Device: Optical Coherence Tomography based AngiographyEvaluate optic nerve head blood flow using the new OCT-A software in surgically and medically treated glaucoma patients and in different types of glaucoma |
| 24-h Intraocular pressure (IOP) arm | – | Device: Optical Coherence Tomography based AngiographyEvaluate the correlation between circadian IOP changes and optic nerve head blood flow using the new OCT-A software |
| Surgery arm | – | Device: Optical Coherence Tomography based AngiographyEvaluate blood flow using the new OCT-A software in surgically treated glaucoma patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center.
Key inclusion criteria (4 listed)
- Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma.
- Documented glaucomatous visual field damage (in the previous 12 months with mean defect (MD) > 2.0 dB)
- Structural and/or functional glaucomatous damage
- Have given written informed consent, prior to any investigational procedures
Key exclusion criteria (5 listed)
- Patients with allergy to corneal anesthetic
- Patients not able to understand the character and individual consequences of the investigation
- Participation in other clinical research within the last 4 weeks
- Other diseases that may cause visual field loss or optic disc abnormalities
- Refractive error of > +3.00D or < -7.00D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography based AngiographyA contrast-free, noninvasive technology to identify blood vessels in the eye | Device | 24-h Intraocular pressure (IOP) arm, Longitudinal arm, Surgery arm |
Primary outcome
Macular and optic nerve head bloodflow, as measured by OCT-A macular and optic nerve head vessel density (%)
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
Kaweh Mansouri, MD principal investigator
Glaucoma center, Montchoisi clinic, Swiss vision network
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 Glaucoma, run by Swiss Vision Network at 1 site in Switzerland.
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 5 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: stopped early, as of the sponsor's last update on 10 May 2022. 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 Switzerland. 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 was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
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?
Macular and optic nerve head bloodflow, as measured by OCT-A macular and optic nerve head vessel density (%) (time frame: Up to 3 years). 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 May 2022.