GlaucomaNCT02548676
Optical Angiography in Glaucoma
An observational study of Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Optical angiography based on OCT
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteAustria
- Study dates
- 11 Sep 2015to 25 Nov 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 open angle glaucoma patients 30 healthy age- and sex matched controls
Who may be able to join
- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test < 10dB
Who cannot join
- Normal ophthalmic findings, IOP ≤ 20mmHg
- No history of elevated IOP
- No signs of glaucomatous disc damage
Trial locations and contacts
1 site in 1 country.
About this study
Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. It has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. In the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. This is of importance because it may clarify the degree of vascular involvement in glaucoma.
- Conditions
- Glaucoma
- Being tested
- Optical angiography based on OCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical angiography based on OCTDevice
This measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Patients | Patients with primary open angle glaucoma Receives: Device: Optical angiography based on OCT | |
| Healthy controls | age- and sex matched controls Receives: Device: Optical angiography based on OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel diameter as extracted from the angiograms
Measured: during the four weeks after the first screening day
Secondary outcomes (3)
Systemic hemodynamics (Blood pressure)
Measured: during the four weeks after the first screening day
Intraocular pressure
Measured: during the four weeks after the first screening day
pulse
Measured: during the four weeks after the first screening day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start11 Sep 2015
- Primary completionNov 2016
- Study completion25 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548676
- Sponsor's protocol ID
- OPHT - 110414
- Status last verified
- Apr 2022
- First submitted
- 4 Sep 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Angiography in Glaucoma
- ClinicalTrials.gov ID
- NCT02548676
- Acronym / sponsor ID
- OPHT - 110414
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 11 Sep 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 25 Nov 2016 (actual)
- First posted
- 14 Sep 2015 (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.
Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. It has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. In the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. This is of importance because it may clarify the degree of vascular involvement in glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Patients | – | Device: Optical angiography based on OCTPatients with primary open angle glaucoma |
| Healthy controls | – | Device: Optical angiography based on OCTage- and sex matched controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 open angle glaucoma patients 30 healthy age- and sex matched controls
Key inclusion criteria (1 listed)
- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated IOP ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test < 10dB
Key exclusion criteria (3 listed)
- Normal ophthalmic findings, IOP ≤ 20mmHg
- No history of elevated IOP
- No signs of glaucomatous disc damage
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 |
|---|---|---|
| Optical angiography based on OCTThis measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner. | Device | Glaucoma Patients, Healthy controls |
Primary outcome
Retinal vessel diameter as extracted from the angiograms
Time frame: during the four weeks after the first screening day
3 secondary outcomes
Systemic hemodynamics (Blood pressure)
Time frame: during the four weeks after the first screening day
Intraocular pressure
Time frame: during the four weeks after the first screening day
pulse
Time frame: during the four weeks after the first screening day
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 7 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 1 inclusion and 3 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 7 Apr 2022. 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?
Retinal vessel diameter as extracted from the angiograms (time frame: during the four weeks after the first screening day). 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 7 Apr 2022.