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NCT01315340 Clinical Trial

Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

Glaucoma Clinical Trial

Official title:
Measurement of Ocular Rigidity, Outflow Facility and Ocular Blood Flow in Glaucomatous and Normal Eyes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01315340
Other study ID # 8068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2011
Est. completion date July 2024

Study information
Verified date August 2022
Source Larissa University Hospital
Contact Ioannis Pallikaris, MD
Phone 2810392351
Email ioanpall@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date July 2024
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ocular rigidity, outflow facility and intraocular pressure measurement
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.

Locations
Country Name City State
Greece Ophthalmology Department, University Hospital of Larissa Larissa

Sponsors (2)
Lead Sponsor Collaborator
Larissa University Hospital University of Crete

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular rigidity coefficient 2 minutes measurement of ocular rigidity
Primary Outflow facility coefficient 3-4 minutes measurement of outflow facility
Secondary Ocular pulse amplitude 6 minutes
Secondary Pulsatile ocular blood flow 6 minutes
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