Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

August 15, 2022 updated by: Anna Dastiridou, Larissa University Hospital

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Larissa, Greece, 41110
        • Recruiting
        • Ophthalmology Department, University Hospital of Larissa
        • Contact:
        • Principal Investigator:
          • Anna Dastiridou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular rigidity coefficient
Time Frame: 2 minutes measurement of ocular rigidity
2 minutes measurement of ocular rigidity
Outflow facility coefficient
Time Frame: 3-4 minutes measurement of outflow facility
3-4 minutes measurement of outflow facility

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

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Collaborators

University of Crete

Investigators

  • Principal Investigator: Ioannis Pallikaris, MD, University of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

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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