GlaucomaNCT02544646
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
A study testing Changes in Ocular rigidity in people with Glaucoma and Primary Open Angle Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- Changes in Ocular rigidity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteAustria
- Study dates
- 13 Oct 2011to 8 Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years
- Normal ophthalmic findings except POAG or Pseudoexfoliation glaucoma (PEX)
- Patients scheduled for trabeculectomy
Who cannot join
- Participation in a clinical trial in the 3 weeks preceeding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- Other types of glaucoma, such as pigmentary glaucoma, history of acute angle closure
- History of previous glaucoma surgery
- Postoperative IOP ≤ 8 mmHg
- Ocular inflammation or infection within the past 3 months
- Topical treatment with any ophthalmic drug except anti-glaucomatous medication
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Official title: Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX
It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume relationship. This equation represents the so called ocular rigidity, which expresses the elasticity of the globe.
In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA) with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude (PA) have to be performed.
Read more
In addition choroidal thickness will be assessed with OCT before and after trabeculectomy, since results in choroidal thickness measurements in patients with glaucoma are controversial.
The focus of this study lies on the changes of ocular rigidity and choroidal thickness after surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or pseudoexfoliation glaucoma (PEX).
- Being tested
- Changes in Ocular rigidity
- Keywords
- trabeculectomy
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in Ocular rigidityOther
measured before the operation and 28±7 days after the operation
| Study group | Role | What they receive |
|---|---|---|
| trabeculectomy | Other | Not described Receives: Other: Changes in Ocular rigidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular rigidity
Change in ocular rigidity after surgery
Measured: Baseline and 28±7 days postoperative
Secondary outcomes (6)
Fundus pulsation amplitude
Measured: Baseline and 28±7 days postoperative
Ocular pulse amplitude
Measured: Baseline and 28±7 days postoperative
Mean arterial pressure
Measured: Baseline and 28±7 days postoperative
Pulse rate
Measured: Baseline and 28±7 days postoperative
Axial eye length
Measured: Baseline and 28±7 days postoperative
choroidal thickness
Measured: Baseline and 28±7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start13 Oct 2011
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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
- NCT02544646
- Sponsor's protocol ID
- OPHT-040411
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2014
- Last updated
- 20 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX
- ClinicalTrials.gov ID
- NCT02544646
- Acronym / sponsor ID
- OPHT-040411
- Keywords
- trabeculectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 13 Oct 2011 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 9 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.
It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume relationship. This equation represents the so called ocular rigidity, which expresses the elasticity of the globe.
In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA) with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude (PA) have to be performed.
In addition choroidal thickness will be assessed with OCT before and after trabeculectomy, since results in choroidal thickness measurements in patients with glaucoma are controversial.
The focus of this study lies on the changes of ocular rigidity and choroidal thickness after surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or pseudoexfoliation glaucoma (PEX).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trabeculectomy | Other | Other: Changes in Ocular rigidity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged over 18 years
- Normal ophthalmic findings except POAG or Pseudoexfoliation glaucoma (PEX)
- Patients scheduled for trabeculectomy
Key exclusion criteria (8 listed)
- Participation in a clinical trial in the 3 weeks preceeding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
- Other types of glaucoma, such as pigmentary glaucoma, history of acute angle closure
- History of previous glaucoma surgery
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 |
|---|---|---|
| Changes in Ocular rigiditymeasured before the operation and 28±7 days after the operation | Other | trabeculectomy |
Primary outcome
Change in ocular rigidity
Time frame: Baseline and 28±7 days postoperative
Change in ocular rigidity after surgery
6 secondary outcomes
Fundus pulsation amplitude
Time frame: Baseline and 28±7 days postoperative
Ocular pulse amplitude
Time frame: Baseline and 28±7 days postoperative
Mean arterial pressure
Time frame: Baseline and 28±7 days postoperative
Pulse rate
Time frame: Baseline and 28±7 days postoperative
Axial eye length
Time frame: Baseline and 28±7 days postoperative
choroidal thickness
Time frame: Baseline and 28±7 days postoperative
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 20 Feb 2020.
Related trials for Glaucoma
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
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.
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?
A study testing Changes in Ocular rigidity in people with Glaucoma and Primary Open Angle 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 3 inclusion and 8 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 20 Feb 2020. 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?
Change in ocular rigidity (time frame: Baseline and 28±7 days postoperative). 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 20 Feb 2020.