Glaucoma, Open-AngleNCT00707226
Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes
An observational study of Glaucoma, Open-Angle and Circadian Rhythm, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle, Circadian Rhythm, Intraocular Pressure
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2000to Dec 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
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.
- Keywords
- Laser Doppler flowmetry, Choroidal blood flow, Fundus pulsation amplitude, Intraocular Pressure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 15 patients with primary open angle glaucoma | |
| 2 | 15 age matched healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
fundus pulsation amplitude choroidal blood flow IOP
Measured: 13 hours
Secondary outcomes (1)
blood pressure, pulse rate
Measured: 13 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startNov 2000
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Michael Georgopoulos, MD, Principal investigator, Department of Clinical Ophthalmology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707226
- Sponsor's protocol ID
- OPHT-171000
- Status last verified
- Jun 2008
- First submitted
- 26 Jun 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Variations in Ocular Blood Flow in Glaucomatous and Normal Eyes
- ClinicalTrials.gov ID
- NCT00707226
- Acronym / sponsor ID
- OPHT-171000
- Keywords
- Laser Doppler flowmetry, Choroidal blood flow, Fundus pulsation amplitude, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2000
- Study completion
- Dec 2001 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –15 patients with primary open angle glaucoma |
| 2 | – | –15 age matched healthy subjects |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fundus pulsation amplitude choroidal blood flow IOP
Time frame: 13 hours
1 secondary outcome
blood pressure, pulse rate
Time frame: 13 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Georgopoulos, MD principal investigator
Department of Clinical Ophthalmology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Circadian Rhythm, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fundus pulsation amplitude choroidal blood flow IOP (time frame: 13 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2008.