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Evaluation of Blood Flow Characteristics in Glaucoma Using Optical Coherence Tomography Angiography (OCT-A).
A Cross-sectional, Prospective, Observational Study to Evaluate Blood Flow Characteristics in Glaucoma Patients Using Optical Coherence Tomography Based Angiography (OCT-A).
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMay 10, 2022
May 1, 2022
4 years
April 13, 2016
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Macular and optic nerve head bloodflow, as measured by OCT-A macular and optic nerve head vessel density (%)
Up to 3 years
Study Arms (3)
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
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
Surgery arm
Evaluate blood flow using the new OCT-A software in surgically treated glaucoma patients
Interventions
A contrast-free, noninvasive technology to identify blood vessels in the eye
Eligibility Criteria
All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glaucoma center, Montchoisi clinic
Lausanne, 1006, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaweh Mansouri, MD
Glaucoma center, Montchoisi clinic, Swiss vision network
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr. Kaweh Mansouri
Study Record Dates
First Submitted
April 13, 2016
First Posted
May 2, 2016
Study Start
December 31, 2015
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
May 10, 2022
Record last verified: 2022-05