Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Larissa University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Crete
Information provided by:
Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01315340
First received: March 9, 2011
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Glaucoma
Procedure: Ocular rigidity, outflow facility and intraocular pressure measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Measurement of Ocular Rigidity, Outflow Facility and Ocular Blood Flow in Glaucomatous and Normal Eyes

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Ocular rigidity coefficient [ Time Frame: 2 minutes measurement of ocular rigidity ] [ Designated as safety issue: No ]
  • Outflow facility coefficient [ Time Frame: 3-4 minutes measurement of outflow facility ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular pulse amplitude [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
  • Pulsatile ocular blood flow [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glaucoma Patients 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.
Active Comparator: Control subjects 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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315340

Contacts
Contact: Ioannis Pallikaris, MD 2810392351 ext +30 ioanpall@gmail.com

Locations
Greece
Ophthalmology Department, University Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact: Anna Dastiridou, MD       anna.dastiridou@gmail.com   
Sub-Investigator: Anna Dastiridou, MD         
Sponsors and Collaborators
Larissa University Hospital
University of Crete
Investigators
Principal Investigator: Ioannis Pallikaris, MD University of Crete