GlaucomaNCT02865473
Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and PEX - a Pilot Study
A study testing Pilocarpine in people with Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the present study is to develop a measurement protocol for optimal imaging of the anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering bleb and pseudoexfoliation deposits on the lens based on measurements in patients with glaucoma and PEX. 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?
- Pilocarpine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- 20 Apr 2016to Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Men and women aged over 18 years
- For patients with primary open angle glaucoma:
- Diagnosed primary open angle glaucoma
- Visual field defects and optic nerve head appearance characteristic for glaucoma
- Open anterior chamber angle as evidenced by gonioscopy
- No previous glaucoma surgery
Show all 24Show fewer
- No previous cataract surgery
- For patients with primary angle closure:
- Angle closure predisposition as evidenced from goniosocopy
- No previous glaucoma surgery
- For patients with neovascular glaucoma:
- Neovascularization in the anterior chamber angle
- For patients with pseudoexfolation deposits on the lens:
- PEX glaucoma as evidenced from slit lamp examination
- Visual field defects and optic nerve head appearance characteristic for glaucoma
- Open anterior chamber angle as evidenced by gonioscopy
- No previous glaucoma or cataract surgery
- For glaucoma patients with filtering bleb after trabeculectomy:
- Patients with history of trabeculectomy secondary to open angle glaucoma in the previous three months
- No cataract surgery
- For healthy volunteers:
- No evidence of ocular disease
- No degenerative changes in the retina in funduscopy after mydriasis
- Ametropia less than 3 dpt.
Who cannot join
- Presence of any abnormalities preventing reliable measurements as judged by the investigator
- Pregnancy, planned pregnancy or lactating
- Ocular inflammation and ocular disease interfering with the study aims as judged by the investigator
Trial locations and contacts
1 site in 1 country.
Gerhard Garhöfer, Assoc. Prof. PD Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhöfer, Assoc. Prof. PD Dr., 0043140400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at
Sabina Sapeta, MD
About this study
Official title: Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and Pseudoexfoliation Syndrome - a Pilot Study
The aim of the present study is to develop a measurement protocol for optimal imaging of the anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering bleb and pseudoexfoliation deposits on the lens based on measurements in patients with glaucoma and PEX. In glaucoma the structures of the anterior chamber are important for classification, therapy, progression and prognosis and imaging of the angle between the iris and the cornea is the key for open angle and closed angle glaucoma differential diagnosis. For this purpose, a customized ultrahigh resolution Spectral Domain OCT will be used to validate whether the protocol can also be more widely applied in these patients. Based on the obtained measurement protocol, further studies investigating anatomy and pathophysiology of the anterior segment of the eye as well as surgical outcome in patients with glaucoma and PEX can be planned.
The aim of the study is to develop a measurement protocol for OCT imaging and characterization of the anterior chamber in glaucoma patients.
- Conditions
- Glaucoma
- Being tested
- Pilocarpine
- Keywords
- Schlemm's canal lumen area, PEX
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilocarpineDrug
topical instillation into the study eye
| Study group | Role | What they receive |
|---|---|---|
| primary open angle glaucoma patients | No intervention | Not described |
| patients with primary angle closure | No intervention | Not described |
| patients with neovascular glaucoma | No intervention | Not described |
| PEX glaucoma patients | No intervention | Not described |
| glaucoma patients with filtering bleb | No intervention | Not described |
| healthy volunteers | Experimental | instillation of antiglaucoma treatment in the study eye Receives: Drug: Pilocarpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-dimensional imaging of the anterior eye segment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start20 Apr 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
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
- NCT02865473
- Sponsor's protocol ID
- OPHT-010915
- Status last verified
- Apr 2022
- First submitted
- 9 Aug 2016
- 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
- Anterior Segment Imaging With Ultrahigh-resolution OCT in Patients With Glaucoma and Pseudoexfoliation Syndrome - a Pilot Study
- ClinicalTrials.gov ID
- NCT02865473
- Acronym / sponsor ID
- OPHT-010915
- Conditions
- Glaucoma
- Keywords
- Schlemm's canal lumen area, PEX
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Aug 2016 (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.
The aim of the present study is to develop a measurement protocol for optimal imaging of the anterior segment of the eye, including anterior chamber angle, Schlemm's canal, filtering bleb and pseudoexfoliation deposits on the lens based on measurements in patients with glaucoma and PEX. In glaucoma the structures of the anterior chamber are important for classification, therapy, progression and prognosis and imaging of the angle between the iris and the cornea is the key for open angle and closed angle glaucoma differential diagnosis. For this purpose, a customized ultrahigh resolution Spectral Domain OCT will be used to validate whether the protocol can also be more widely applied in these patients. Based on the obtained measurement protocol, further studies investigating anatomy and pathophysiology of the anterior segment of the eye as well as surgical outcome in patients with glaucoma and PEX can be planned.
The aim of the study is to develop a measurement protocol for OCT imaging and characterization of the anterior chamber in glaucoma patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| primary open angle glaucoma patients | No intervention | – |
| patients with primary angle closure | No intervention | – |
| patients with neovascular glaucoma | No intervention | – |
| PEX glaucoma patients | No intervention | – |
| glaucoma patients with filtering bleb | No intervention | – |
| healthy volunteers | Experimental | Drug: Pilocarpineinstillation of antiglaucoma treatment in the study eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Men and women aged over 18 years
- Diagnosed primary open angle glaucoma
- Visual field defects and optic nerve head appearance characteristic for glaucoma
- Open anterior chamber angle as evidenced by gonioscopy
- No previous glaucoma surgery
Key exclusion criteria (3 listed)
- Presence of any abnormalities preventing reliable measurements as judged by the investigator
- Pregnancy, planned pregnancy or lactating
- Ocular inflammation and ocular disease interfering with the study aims as judged by the investigator
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 |
|---|---|---|
| Pilocarpinetopical instillation into the study eye | Drug | healthy volunteers |
Primary outcome
3-dimensional imaging of the anterior eye segment
Time frame: 1 day
Results and safety
Results are not available in the source record.
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.
Gerhard Garhöfer, Assoc. Prof. PD Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilocarpine in people with 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 24 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, Assoc. Prof. PD Dr. (0043140400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-dimensional imaging of the anterior eye segment (time frame: 1 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.