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).

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 Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Device: Optical Coherence Tomography based Angiography

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1006
    • Glaucoma center, Montchoisi clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Optical Coherence Tomography based Angiography; A contrast-free, noninvasive technology to identify blood vessels in the eye
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	Device: Optical Coherence Tomography based Angiography; A contrast-free, noninvasive technology to identify blood vessels in the eye
Surgery arm; Evaluate blood flow using the new OCT-A software in surgically treated glaucoma patients	Device: Optical Coherence Tomography based Angiography; A contrast-free, noninvasive technology to identify blood vessels in the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Macular and optic nerve head bloodflow, as measured by OCT-A macular and optic nerve head vessel density (%)	Up to 3 years

Collaborators and Investigators

• Sponsor: Swiss Vision Network
• Investigators: Principal Investigator: Kaweh Mansouri, MD, Glaucoma center, Montchoisi clinic, Swiss vision network

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: GR-02