Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

NCT01315340 | Unknown

• 1 other identifier: 8068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Ocular rigidity coefficient

  2 minutes measurement of ocular rigidity

• Outflow facility coefficient

  3-4 minutes measurement of outflow facility

Secondary Outcomes (2)

• Ocular pulse amplitude

  6 minutes

• Pulsatile ocular blood flow

  6 minutes

Study Arms (2)

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

Interventions

Ocular rigidity, outflow facility and intraocular pressure measurement PROCEDURE

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.

Control subjects; Glaucoma Patients

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary open or pseudoexfoliation glaucoma that are undergoing cataract surgery
• Patients undergoing cataract surgery without evidence of other ocular disease.

You may not qualify if:

• Previous ophthalmic surgery or trauma
• Significant visual field defect (MD\<-12dB) or an increased cup to disc ratio (\>0.9).

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Crete: collaborator

Study Sites (1)

Ophthalmology Department, University Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

Related Publications (6)

• 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.

  PMID: 19608534 BACKGROUND

• 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.

  PMID: 16564793 BACKGROUND

• 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.

  PMID: 15671262 BACKGROUND

• 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.

  PMID: 23462745 BACKGROUND

• 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.

  PMID: 23761082 BACKGROUND

• 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.

  PMID: 25645503 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Intraocular Pressure

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

• Ioannis Pallikaris, MD

  University of Crete

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioannis Pallikaris, MD

CONTACT

2810392351; ioanpall@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 15, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

GR (1)