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Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

Primary Purpose

Glaucoma

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Ocular rigidity, outflow facility and intraocular pressure measurement

About this trial

This is an interventional basic science trial for Glaucoma

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Ophthalmology Department, University Hospital of LarissaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glaucoma Patients

Control subjects

Arm Description

Outcomes

Primary Outcome Measures

Ocular rigidity coefficient

Outflow facility coefficient

Secondary Outcome Measures

Ocular pulse amplitude

Pulsatile ocular blood flow

Full Information

NCT ID

NCT01315340

First Posted

March 9, 2011

Last Updated

August 15, 2022

Sponsor

Larissa University Hospital

Collaborators

University of Crete

1. Study Identification

Unique Protocol Identification Number

NCT01315340

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Larissa University Hospital

Collaborators

University of Crete

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Glaucoma Patients

Arm Type

Experimental

Arm Title

Control subjects

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Ocular rigidity, outflow facility and intraocular pressure measurement

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ocular rigidity coefficient

Time Frame

2 minutes measurement of ocular rigidity

Title

Outflow facility coefficient

Time Frame

3-4 minutes measurement of outflow facility

Secondary Outcome Measure Information:

Title

Ocular pulse amplitude

Time Frame

6 minutes

Title

Pulsatile ocular blood flow

Time Frame

6 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ioannis Pallikaris, MD

Phone

2810392351

Ext

+30

ioanpall@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ioannis Pallikaris, MD

Organizational Affiliation

University of Crete

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmology Department, University Hospital of Larissa

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Dastiridou, MD

anna.dastiridou@gmail.com

First Name & Middle Initial & Last Name & Degree

Anna Dastiridou, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19608534

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.

Results Reference

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PubMed Identifier

16564793

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.

Results Reference

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PubMed Identifier

15671262

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.

Results Reference

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PubMed Identifier

23462745

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.

Results Reference

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PubMed Identifier

23761082

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.

Results Reference

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PubMed Identifier

25645503

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.

Results Reference

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Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

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