- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656979
Blood Flow of Ophthalmic Artery and Glaucoma
Blood Flow of Ophthalmic Artery and Its Relationship to Structural Properties of the Optic Nerve and Intraocular Pressure in Glaucoma
Study Overview
Detailed Description
The investigators will investigate the OA blood flow, intraocular pressure (IOP) and structural properties of the optic nerve. The investigators will include glaucoma patients as they believe that glaucoma may be caused by or influenced by OA blood flow. The investigators will include also patients with intraocular hypertension with and without pseudoexfoliation in order to study how changes in IOP interact with OA blood flow and the structural properties of the optic nerve in a group that does not develop glaucoma. In addition, the investigators will investigate patients that develop glaucoma in spite of a normal IOP. Therefore, the investigators will study three fundamentally different groups (G1, G2 and G3) of patients as well as a control group of healthy subjects (G4):
G1: Newly diagnosed and untreated Glaucoma (optic and visual field damage exists).
G2: Ocular hypertension with IOP ≥ 23 mmHg (i.e. only elevated eye pressure).
G3: Normal Tension Glaucoma.
G4: Healthy subjects.
Each group will include 25 patients apart from G2 where 50 patients will be included, half of which have pseudoexfoliation syndrome. The study will be performed in accordance with the tenets of the Helsinki Declaration and is approved by the regional ethical board.
Study protocol overview:
Study protocol consists of two parts of examinations repeated with approximately one week between: Each part is divided into two examinations; one at the Department of radiology followed by one at the Department of ophthalmology. The measurements are repeated approximately one week later for G1 and G2.
Day 1: First, MRI scans on the brain to measure the blood flow of OA as well as the structural and morphological properties of the ON (see method below). Second, just after MRI examination, the patient will be examined at the Department of ophthalmology. Measurement of intraocular pressure, ocular pulse amplitude, central corneal thickness, bulb length, investigation with optical coherence tomography (OCT) and blood pressure will be performed. The patients from G3 (Normal Pressure Glaucoma) will participate only in Day 1, since most cases already has pressure-lowering treatment. Also subjects in G4 vill only participate in Day 1. All other participants will receive pressure lowering drug (Latanoprost) in one eye once daily, until the protocol is repeated at Day 2.
Day 2: The measurements at Day 1 are repeated approximately one week later. The measurements will be made in both eyes, which is why an eye can serve as a control. That way the investigators will have a good opportunity to assess how much of the change the investigators see in the treated eye that may be due to normal variations in OA blood flow and how much depends on the given treatment.
The findings will be compared between the groups and to the normal material in G4. The investigators will be able to see whether, and if so, to what extent, eyes with glaucoma differ from normal eyes in terms of blood flow through OA as compared to the IOP measurements, and different biomechanical parameters of the eye. Thus, determine the pressure dynamics and calculate ocular compliance with the three different groups of research subjects; newly diagnosed glaucoma, ocular hypertension, normal tension glaucoma.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gauti Jóhannesson, M.D., Ph.D.
- Phone Number: +46702200798
- Email: gauti.johannesson@umu.se
Study Contact Backup
- Name: Christina Lindén, M.D., Ph.D.
- Phone Number: +46907850000
- Email: christina.linden@umu.se
Study Locations
-
-
Västerbotten
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Umeå, Västerbotten, Sweden, 90187
- Recruiting
- Department of Clinical Science, Ophthalmology, Umeå University
-
Contact:
- Gauti Jóhannesson, M.D., Ph.D.
- Phone Number: +46702200798
- Email: gauti.johannesson@umu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Newly diagnosed and untreated glaucoma patients
- Treated normal tension glaucoma patients
- Untreated patients with ocular hypertension
- Subjects with healthy eyes
Exclusion Criteria:
- Heart disease except treated hypertension
- Intracranial pathology such as stroke, tumor, previous intracranial surgery
- Insulin treated diabetes mellitus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Blood flow pre&post IOP lowering
After measurement of blood flow with MRI and measurements of ocular parameters the patient receives the IOP lowering eye drop latanoprost once daily in one eye for approximately one week and then the measurements are are repeated in the same manner.
|
Between measurements on day 1 and day 2, the subjects will receive a drop of latanoprost which is an IOP lowering drug once daily in one eye.
|
No Intervention: Blood flow
The subjects will do blood flow measurements with MRI and measurements of ocular parameters only once.
No intervention with IOP lowering drops.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The blood flow (ml/min) of the ophthalmic artery in patients with different types of glaucoma/ocular hypertension and healthy individuals will be measured with MRI
Time Frame: Up to four years
|
Up to four years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of ophthalmic artery blood flow (ml/min) after a reduction in IOP in glaucoma and intraocular hypertension will be measured with MRI
Time Frame: Up to four years
|
Up to four years
|
The change of structural properties (μm) of the optic nerve after a reduction in IOP in glaucoma and intraocular hypertension will be measured with MRI
Time Frame: Up to four years
|
Up to four years
|
Difference in the ophthalmic artery blood flow (ml/min) measured with MRI in patients with ocular hypertension with and without pseudoexfoliation.
Time Frame: Up to four years
|
Up to four years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gauti Jóhannesson, M.D., Ph.D., Department of Clinical Science, Ophthalmology, Umeå University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UmeaU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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