Clinical trial NCT01315340: Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes
Official title: Measurement of Ocular Rigidity, Outflow Facility and Ocular Blood Flow in Glaucomatous and Normal Eyes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Crete
First posted: 2011-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Ocular rigidity coefficient
timeFrame: 2 minutes measurement of ocular rigidity
measure: Outflow facility coefficient
timeFrame: 3-4 minutes measurement of outflow facility
Secondary outcomes:
measure: Ocular pulse amplitude
timeFrame: 6 minutes
measure: Pulsatile ocular blood flow
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Ophthalmology Department, University Hospital of Larissa
Study officials:
affiliation: University of Crete
name: Ioannis Pallikaris, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/j.ajo.2005.11.010.
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. doi: 10.1167/iovs.04-0162.
citation: 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.
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.
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-e348. doi: 10.1111/aos.12652. Epub 2015 Feb 1.