Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00707226

Enrollment

Registered

2008-06-30

Start date

2000-11-30

Completion date

2001-12-31

Last updated

2008-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm, Glaucoma, Open-Angle, Intraocular Pressure, Regional Blood Flow

Keywords

Laser Doppler flowmetry, Choroidal blood flow, Fundus pulsation amplitude, Intraocular Pressure

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
fundus pulsation amplitude choroidal blood flow IOP	13 hours

Secondary

Measure	Time frame
blood pressure, pulse rate	13 hours

Countries

Austria

Outcome results