GlaucomaNCT01315340
Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes
A study testing Ocular rigidity, outflow facility and intraocular pressure measurement in people with Glaucoma, run by Larissa University Hospital at 1 site in Greece.
Trial summary
Ocular rigidity characterizes the relationship between pressure and volume changes in the human eye and is expressed as a macroscopic coefficient. Outflow facility is a measure of the resistance of the conventional outflow pathway and represents a parameter that is of interest in glaucoma. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ocular rigidity, outflow facility and intraocular pressure measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to Jul 2024
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with primary open or pseudoexfoliation glaucoma that are undergoing cataract surgery
- Patients undergoing cataract surgery without evidence of other ocular disease.
Who cannot join
- Evidence of any ocular disease, other than specified in the inclusion criteria
- Previous ophthalmic surgery or trauma
- Significant visual field defect (MD<-12dB) or an increased cup to disc ratio (>0.9).
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Ophthalmology Department, University Hospital of Larissa
Larissa, 41110
Anna Dastiridou, MD, anna.dastiridou@gmail.com
Anna Dastiridou, MD
About this study
Official title: Measurement of Ocular Rigidity, Outflow Facility and Ocular Blood Flow in Glaucomatous and Normal Eyes
Ocular rigidity characterizes the relationship between pressure and volume changes in the human eye and is expressed as a macroscopic coefficient. Outflow facility is a measure of the resistance of the conventional outflow pathway and represents a parameter that is of interest in glaucoma.
Difficulties in the measurement of ocular rigidity in the living human eye have limited our knowledge on this parameter. However, ocular biomechanics have been implicated in the pathogenesis of this disease. The aim of this study is to characterize the pressure volume relation and quantify ocular rigidity and outflow facility in glaucomatous and normal eyes. For this purpose, the investigators have recently developed a manometric method for the measurement of ocular rigidity and outflow facility.
- Conditions
- Glaucoma
- Being tested
- Ocular rigidity, outflow facility and intraocular pressure measurement
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular rigidity, outflow facility and intraocular pressure measurementProcedure or surgery
The measurement procedure includes cannulation of the anterior chamber of the eye, under sterile conditions. Infusion of the eye with microvolumes of a saline solution is performed, followed by manometric measurement of intraocular pressure, in order to quantify ocular rigidity. Outflow facility is estimated from recordings of intraocular pressure after the infusion is stopped.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Patients | Experimental | Not described Receives: Procedure: Ocular rigidity, outflow facility and intraocular pressure measurement |
| Control subjects | Active comparator | Not described Receives: Procedure: Ocular rigidity, outflow facility and intraocular pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular rigidity coefficient
Measured: 2 minutes measurement of ocular rigidity
Outflow facility coefficient
Measured: 3-4 minutes measurement of outflow facility
Secondary outcomes (2)
Ocular pulse amplitude
Measured: 6 minutes
Pulsatile ocular blood flow
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Crete
- Responsible party
- Principal investigator, Anna Dastiridou, Larissa University Hospital
- Investigators
- Ioannis Pallikaris, MD, Principal investigator, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315340
- Sponsor's protocol ID
- 8068
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2011
- Last updated
- 16 Aug 2022
- Results posted
- No
Publications
Dastiridou AI, Ginis HS, De Brouwere D, Tsilimbaris MK, Pallikaris IG. Ocular rigidity, ocular pulse amplitude, and pulsatile ocular blood flow: the effect of intraocular pressure. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5718-22. doi: 10.1167/iovs.09-3760. Epub 2009 Jul 15.
PubMed 19608534Pallikaris IG, Kymionis GD, Ginis HS, Kounis GA, Christodoulakis E, Tsilimbaris MK. Ocular rigidity in patients with age-related macular degeneration. Am J Ophthalmol. 2006 Apr;141(4):611-5. doi: 10.1016/j.ajo.2005.11.010.
PubMed 16564793Pallikaris IG, Kymionis GD, Ginis HS, Kounis GA, Tsilimbaris MK. Ocular rigidity in living human eyes. Invest Ophthalmol Vis Sci. 2005 Feb;46(2):409-14. doi: 10.1167/iovs.04-0162.
PubMed 15671262Dastiridou AI, Ginis H, Tsilimbaris M, Karyotakis N, Detorakis E, Siganos C, Cholevas P, Tsironi EE, Pallikaris IG. Ocular rigidity, ocular pulse amplitude, and pulsatile ocular blood flow: the effect of axial length. Invest Ophthalmol Vis Sci. 2013 Mar 1;54(3):2087-92. doi: 10.1167/iovs.12-11576.
PubMed 23462745Dastiridou AI, Tsironi EE, Tsilimbaris MK, Ginis H, Karyotakis N, Cholevas P, Androudi S, Pallikaris IG. Ocular rigidity, outflow facility, ocular pulse amplitude, and pulsatile ocular blood flow in open-angle glaucoma: a manometric study. Invest Ophthalmol Vis Sci. 2013 Jul 10;54(7):4571-7. doi: 10.1167/iovs.13-12303.
PubMed 23761082Karyotakis NG, Ginis HS, Dastiridou AI, Tsilimbaris MK, Pallikaris IG. Manometric measurement of the outflow facility in the living human eye and its dependence on intraocular pressure. Acta Ophthalmol. 2015 Aug;93(5):e343-e348. doi: 10.1111/aos.12652. Epub 2015 Feb 1.
PubMed 25645503
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Ocular Rigidity, Outflow Facility and Ocular Blood Flow in Glaucomatous and Normal Eyes
- ClinicalTrials.gov ID
- NCT01315340
- Acronym / sponsor ID
- 8068
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Crete
- Study start
- Mar 2011
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Mar 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.
Ocular rigidity characterizes the relationship between pressure and volume changes in the human eye and is expressed as a macroscopic coefficient. Outflow facility is a measure of the resistance of the conventional outflow pathway and represents a parameter that is of interest in glaucoma.
Difficulties in the measurement of ocular rigidity in the living human eye have limited our knowledge on this parameter. However, ocular biomechanics have been implicated in the pathogenesis of this disease. The aim of this study is to characterize the pressure volume relation and quantify ocular rigidity and outflow facility in glaucomatous and normal eyes. For this purpose, the investigators have recently developed a manometric method for the measurement of ocular rigidity and outflow facility.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Patients | Experimental | Procedure: Ocular rigidity, outflow facility and intraocular pressure measurement |
| Control subjects | Active comparator | Procedure: Ocular rigidity, outflow facility and intraocular pressure measurement |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary open or pseudoexfoliation glaucoma that are undergoing cataract surgery
- Patients undergoing cataract surgery without evidence of other ocular disease.
Key exclusion criteria (3 listed)
- Evidence of any ocular disease, other than specified in the inclusion criteria
- Previous ophthalmic surgery or trauma
- Significant visual field defect (MD<-12dB) or an increased cup to disc ratio (>0.9).
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 |
|---|---|---|
| Ocular rigidity, outflow facility and intraocular pressure measurementThe measurement procedure includes cannulation of the anterior chamber of the eye, under sterile conditions. Infusion of the eye with microvolumes of a saline solution is performed, followed by manometric measurement of intraocular pressure, in order to quantify ocular rigidity. Outflow facility is estimated from recordings of intraocular pressure after the infusion is stopped. | Procedure or surgery | Control subjects, Glaucoma Patients |
Primary outcome
Ocular rigidity coefficient
Time frame: 2 minutes measurement of ocular rigidity
Outflow facility coefficient
Time frame: 3-4 minutes measurement of outflow facility
2 secondary outcomes
Ocular pulse amplitude
Time frame: 6 minutes
Pulsatile ocular blood flow
Time frame: 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 19608534Dastiridou AI, Ginis HS, De Brouwere D, Tsilimbaris MK, Pallikaris IG. Ocular rigidity, ocular pulse amplitude, and pulsatile ocular blood flow: the effect of intraocular pressure. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5718-22. doi: 10.1167/iovs.09-3760. Epub 2009 Jul 15.
- Background: PubMed 16564793Pallikaris IG, Kymionis GD, Ginis HS, Kounis GA, Christodoulakis E, Tsilimbaris MK. Ocular rigidity in patients with age-related macular degeneration. Am J Ophthalmol. 2006 Apr;141(4):611-5. doi: 10.1016/j.ajo.2005.11.010.
- Background: PubMed 15671262Pallikaris IG, Kymionis GD, Ginis HS, Kounis GA, Tsilimbaris MK. Ocular rigidity in living human eyes. Invest Ophthalmol Vis Sci. 2005 Feb;46(2):409-14. doi: 10.1167/iovs.04-0162.
- Background: PubMed 23462745Dastiridou AI, Ginis H, Tsilimbaris M, Karyotakis N, Detorakis E, Siganos C, Cholevas P, Tsironi EE, Pallikaris IG. Ocular rigidity, ocular pulse amplitude, and pulsatile ocular blood flow: the effect of axial length. Invest Ophthalmol Vis Sci. 2013 Mar 1;54(3):2087-92. doi: 10.1167/iovs.12-11576.
- Background: PubMed 23761082Dastiridou AI, Tsironi EE, Tsilimbaris MK, Ginis H, Karyotakis N, Cholevas P, Androudi S, Pallikaris IG. Ocular rigidity, outflow facility, ocular pulse amplitude, and pulsatile ocular blood flow in open-angle glaucoma: a manometric study. Invest Ophthalmol Vis Sci. 2013 Jul 10;54(7):4571-7. doi: 10.1167/iovs.13-12303.
- Background: PubMed 25645503Karyotakis NG, Ginis HS, Dastiridou AI, Tsilimbaris MK, Pallikaris IG. Manometric measurement of the outflow facility in the living human eye and its dependence on intraocular pressure. Acta Ophthalmol. 2015 Aug;93(5):e343-e348. doi: 10.1111/aos.12652. Epub 2015 Feb 1.
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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.
Ioannis Pallikaris, MD principal investigator
University of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular rigidity, outflow facility and intraocular pressure measurement in people with Glaucoma, run by Larissa University Hospital at 1 site in Greece.
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 2 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 16 Aug 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 Greece. 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 Ioannis Pallikaris, MD (2810392351 ext. +30, ioanpall@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular rigidity coefficient (time frame: 2 minutes measurement of ocular rigidity). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315340, which also lists 6 linked publications.
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 16 Aug 2022.