Blood Flow of Ophthalmic Artery and Glaucoma
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Latanoprost
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, Blood flow, Pseudoexfoliation, Intraocular pressure, Brain perfusion, Magnetic Resonance Imaging
Eligibility Criteria
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
Sites / Locations
- Department of Clinical Science, Ophthalmology, Umeå UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Blood flow pre&post IOP lowering
Blood flow
Arm Description
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.
The subjects will do blood flow measurements with MRI and measurements of ocular parameters only once. No intervention with IOP lowering drops.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The change of ophthalmic artery blood flow (ml/min) after a reduction in IOP in glaucoma and intraocular hypertension will be measured with MRI
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
Difference in the ophthalmic artery blood flow (ml/min) measured with MRI in patients with ocular hypertension with and without pseudoexfoliation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02656979
Brief Title
Blood Flow of Ophthalmic Artery and Glaucoma
Official Title
Blood Flow of Ophthalmic Artery and Its Relationship to Structural Properties of the Optic Nerve and Intraocular Pressure in Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this project is to investigate the blood flow of the ophthalmic artery (OA) in patients with ocular hypertension, high tension glaucoma and normal tension glaucoma. It is also to study the influence of the intraocular pressure difference on OA blood flow in the two first groups. Furthermore, the investigators want to understand the relationship between ocular dynamics, blood flow and structural alternations of the optic nerve head (ONH). The rationale behind the study is to improve knowledge of the pathogenesis of glaucoma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Blood flow, Pseudoexfoliation, Intraocular pressure, Brain perfusion, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood flow pre&post IOP lowering
Arm Type
Other
Arm Description
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.
Arm Title
Blood flow
Arm Type
No Intervention
Arm Description
The subjects will do blood flow measurements with MRI and measurements of ocular parameters only once. No intervention with IOP lowering drops.
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gauti Jóhannesson, M.D., Ph.D.
Phone
+46702200798
Email
gauti.johannesson@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Lindén, M.D., Ph.D.
Phone
+46907850000
Email
christina.linden@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauti Jóhannesson, M.D., Ph.D.
Organizational Affiliation
Department of Clinical Science, Ophthalmology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Science, Ophthalmology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90187
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gauti Jóhannesson, M.D., Ph.D.
Phone
+46702200798
Email
gauti.johannesson@umu.se
12. IPD Sharing Statement
Learn more about this trial
Blood Flow of Ophthalmic Artery and Glaucoma
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