Open Angle GlaucomaNCT01304264
Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations in Glaucoma Patients
An observational study of Open Angle Glaucoma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Color Doppler Imaging
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteLithuania
- Study dates
- Mar 2011to Nov 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Regular visitors of Eye Clinic of Lithuania University of Health Science hospital
Who may be able to join
- Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes
Who cannot join
- younger than 18 years old
- women of child bearing potential
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Eye Clinic Lithuania Health Science Hospital Kaunas Clinics
Kaunas, 50009
About this study
Official title: Comparison of Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations During the Addition of Dorzolamid vs Timolol in Glaucoma Subjects Treated With Prostaglandin Analogue Monotherapy
To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow
Read the detailed description
Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation
- Conditions
- Open Angle Glaucoma
- Being tested
- Color Doppler Imaging
- Keywords
- glaucoma, ocular, blood flow, fluctuations
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Doppler ImagingDevice
Also called timololum maleate, dorzolamidum, latanoprostum
Color Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV).
| Study group | Role | What they receive |
|---|---|---|
| combination topical glaucoma treatment | timolol or dorzolamide add on latanoprost monotherapy Receives: Device: Color Doppler Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Color Doppler Imaging
Color Doppler Imaging
- Nasal post ciliary artery (NPCA)
- Temporal posterior ciliary artery (TPCA)
- Ophthalmic artery (OA)
- Central retinal artery (CRA)
Measured: 8 AM; 8 PM
Secondary outcomes (1)
IOP, BP, OPP (mean, fluctuations, amplitude)
IOP, BP, OPP (mean, fluctuations, amplitude) Goldmann applanation tonometry Brachial artery pressure and radial pulse
Measured: 8 AM-12AM-4PM-8PM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Ingrida Januleviciene, Lithuanian University of Health Sciences
- Investigators
- Ingrida Januleviciene, MD, Principal investigator, Lithuania University of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304264
- Sponsor's protocol ID
- 37552
- Status last verified
- Jan 2012
- First submitted
- 24 Feb 2011
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraocular Pressure, Blood Pressure, Ocular Perfusion and Blood Flow Fluctuations During the Addition of Dorzolamid vs Timolol in Glaucoma Subjects Treated With Prostaglandin Analogue Monotherapy
- ClinicalTrials.gov ID
- NCT01304264
- Acronym / sponsor ID
- 37552
- Conditions
- Open Angle Glaucoma
- Keywords
- glaucoma, ocular, blood flow, fluctuations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Indiana University, Merck Sharp & Dohme LLC
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Feb 2011 (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.
To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow
Detailed description
Hypotensive treatments for glaucomatous optic neuropathy (GON), depending on their chemical composition can influence the ocular circulation independent of intraocular pressure (IOP) reduction. It is therefore important not only to identify ocular blood flow deficits in GON, but also document the influence of GON treatments on the ocular circulation
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination topical glaucoma treatment | – | Device: Color Doppler Imagingtimolol or dorzolamide add on latanoprost monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Regular visitors of Eye Clinic of Lithuania University of Health Science hospital
Key inclusion criteria (1 listed)
- Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes
Key exclusion criteria (2 listed)
- younger than 18 years old
- women of child bearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Color Doppler ImagingAlso: timololum maleate, dorzolamidum, latanoprostumColor Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV). | Device | combination topical glaucoma treatment |
Primary outcome
Ocular Color Doppler Imaging
Time frame: 8 AM; 8 PM
Color Doppler Imaging * Nasal post ciliary artery (NPCA) * Temporal posterior ciliary artery (TPCA) * Ophthalmic artery (OA) * Central retinal artery (CRA)
1 secondary outcome
IOP, BP, OPP (mean, fluctuations, amplitude)
Time frame: 8 AM-12AM-4PM-8PM
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 12 Jan 2012.
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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.
Ingrida Januleviciene, MD principal investigator
Lithuania University of Health Science
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 Open Angle Glaucoma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 1 inclusion and 2 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 12 Jan 2012. 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 Lithuania. 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?
Ocular Color Doppler Imaging (time frame: 8 AM; 8 PM). 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 12 Jan 2012.