Evaluation of Blood Flow Characteristics in Glaucoma Using Optical Coherence Tomography Angiography (OCT-A).

Terminated

• Conditions: Glaucoma
• Interventions: Device: Optical Coherence Tomography based Angiography

• Registration Number: NCT02757677
• Lead Sponsor: Swiss Vision Network

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-31
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
24-h Intraocular pressure (IOP) arm	Optical Coherence Tomography based Angiography	Evaluate the correlation between circadian IOP changes and optic nerve head blood flow using the new OCT-A software
Surgery arm	Optical Coherence Tomography based Angiography	Evaluate blood flow using the new OCT-A software in surgically treated glaucoma patients
Longitudinal arm	Optical Coherence Tomography based Angiography	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Glaucoma center, Montchoisi clinic; 🇨🇭 Lausanne, Switzerland