Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00707226
First received: June 26, 2008
Last updated: June 27, 2008
Last verified: June 2008

June 26, 2008
June 27, 2008
November 2000
Not Provided
fundus pulsation amplitude choroidal blood flow IOP [ Time Frame: 13 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00707226 on ClinicalTrials.gov Archive Site
blood pressure, pulse rate [ Time Frame: 13 hours ] [ Designated as safety issue: No ]
Same as current
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Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes
Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes

After focusing many years only on intraocular pressure (IOP) as the primary risk factor, recently the impact of ocular blood flow is getting more consideration for the pathophysiology of glaucoma. The circadian change of intraocular pressure (IOP) is well investigated, but diurnal variations in ocular blood flow are yet to be evaluated, especially in glaucomatous eyes.

This study is performed to investigate circadian variation of ocular blood flow assessed by laser interferometric fundus pulsation amplitude (FPA) and laser Doppler flowmetry (LDF) in glaucomatous eyes during topical antiglaucoma therapy at 8:00, 12:00, 17:00 and 21:00, to compare these circadian variation of ocular blood flow in glaucomatous eyes with variations in healthy eyes and to relate blood flow variations with IOP variations.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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  • Glaucoma, Open-Angle
  • Circadian Rhythm
  • Intraocular Pressure
  • Regional Blood Flow
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  • 1
    15 patients with primary open angle glaucoma
  • 2
    15 age matched healthy subjects
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2001
Not Provided

Inclusion Criteria:

For the glaucoma patients:

  • Medical controlled Primary Open Angle Glaucoma with a history of more than 2 years
  • Topical medication with beta-blockers (timolol, betaxolol, levobunol)
  • IOP with medication < 22 mmHg (with a medical history of IOP > 22 mmHg)
  • Visual field testing: mild glaucomatous defects (Humphrey 30-2 with MD>10)
  • Optic nerve head: C/D-ratio between 0.4 and 0.9
  • ametropy < 3 dpt
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

For the age matched control subjects:

  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropy < 3 dpt.

Exclusion Criteria:

For the glaucoma patients:

  • History of trabeculectomy or laser trabeculoplasty
  • Any other ocular disease with possible vascular involvement such as diabetic retinopathy, age related macular disease, retinal vein or artery occlusion.
  • Uncontrolled systemic hypertension (defined as systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg)
  • Diabetes mellitus

For the age matched control subjects:

  • abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease
  • Ametropy > 3 dpt
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00707226
OPHT-171000
Not Provided
Michael Georgopoulos, Medical University of Vienna
Medical University of Vienna
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Principal Investigator: Michael Georgopoulos, MD Department of Clinical Ophthalmology, Medical University of Vienna
Medical University of Vienna
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP