Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
125 participants
INTERVENTIONAL
2013-12-31
2019-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
Latanoprost
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.
Blood flow
The subjects will do blood flow measurements with MRI and measurements of ocular parameters only once. No intervention with IOP lowering drops.
No interventions assigned to this group
Interventions
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Latanoprost
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.
Eligibility Criteria
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Inclusion Criteria
* Treated normal tension glaucoma patients
* Untreated patients with ocular hypertension
* Subjects with healthy eyes
Exclusion Criteria
* Intracranial pathology such as stroke, tumor, previous intracranial surgery
* Insulin treated diabetes mellitus
55 Years
85 Years
ALL
Yes
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Gauti Jóhannesson, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Science, Ophthalmology, Umeå University
Locations
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Department of Clinical Science, Ophthalmology, Umeå University
Umeå, Västerbotten County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UmeaU
Identifier Type: -
Identifier Source: org_study_id
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