- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315340
Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ioannis Pallikaris, MD
- Phone Number: +30 2810392351
- Email: ioanpall@gmail.com
Study Locations
-
-
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Larissa, Greece, 41110
- Recruiting
- Ophthalmology Department, University Hospital of Larissa
-
Contact:
- Anna Dastiridou, MD
- Email: anna.dastiridou@gmail.com
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Principal Investigator:
- Anna Dastiridou, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with primary open or pseudoexfoliation glaucoma that are undergoing cataract surgery
- Patients undergoing cataract surgery without evidence of other ocular disease.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Glaucoma Patients
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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.
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Active Comparator: Control subjects
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ocular rigidity coefficient
Time Frame: 2 minutes measurement of ocular rigidity
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2 minutes measurement of ocular rigidity
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Outflow facility coefficient
Time Frame: 3-4 minutes measurement of outflow facility
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3-4 minutes measurement of outflow facility
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ocular pulse amplitude
Time Frame: 6 minutes
|
6 minutes
|
Pulsatile ocular blood flow
Time Frame: 6 minutes
|
6 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ioannis Pallikaris, MD, University of Crete
Publications and helpful links
General 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.
- Pallikaris 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.
- Pallikaris 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.
- Dastiridou 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.
- Dastiridou 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.
- Karyotakis 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):e343-8. doi: 10.1111/aos.12652. Epub 2015 Feb 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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