NCT02656979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 2, 2019

Status Verified

February 1, 2019

Enrollment Period

5.8 years

First QC Date

December 15, 2015

Last Update Submit

August 1, 2019

Conditions

Glaucoma

Keywords

GlaucomaBlood flowPseudoexfoliationIntraocular pressureBrain perfusionMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to four years

Secondary Outcomes (3)

  • The change of ophthalmic artery blood flow (ml/min) after a reduction in IOP in glaucoma and intraocular hypertension will be measured with MRI

    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

    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.

    Up to four years

Study Arms (2)

Blood flow pre&post IOP lowering

OTHER

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.

Drug: Latanoprost

Blood flow

NO INTERVENTION

The subjects will do blood flow measurements with MRI and measurements of ocular parameters only once. No intervention with IOP lowering drops.

Interventions

LatanoprostDRUG

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 pre&post IOP lowering

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed and untreated glaucoma patients
  • Treated normal tension glaucoma patients
  • Untreated patients with ocular hypertension
  • Subjects with healthy eyes

You may not qualify if:

  • Heart disease except treated hypertension
  • Intracranial pathology such as stroke, tumor, previous intracranial surgery
  • Insulin treated diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Science, Ophthalmology, Umeå University

Umeå, Västerbotten County, 90187, Sweden

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Gauti Jóhannesson, M.D., Ph.D.

    Department of Clinical Science, Ophthalmology, Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gauti Jóhannesson, M.D., Ph.D.

CONTACT

+46702200798gauti.johannesson@umu.se

Christina Lindén, M.D., Ph.D.

CONTACT

+46907850000christina.linden@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 15, 2016

Study Start

December 1, 2013

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

August 2, 2019

Record last verified: 2019-02

Locations

SE(1)