Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

Not Applicable

• Conditions: Glaucoma
• Interventions: Procedure: Ocular rigidity, outflow facility and intraocular pressure measurement

• Registration Number: NCT01315340
• Lead Sponsor: Larissa University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Primary Completion: 2023-03
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucoma Patients	Ocular rigidity, outflow facility and intraocular pressure measurement	-
Control subjects	Ocular rigidity, outflow facility and intraocular pressure measurement	-

Primary Outcome Measures

Name	Time	Method
Ocular rigidity coefficient	2 minutes measurement of ocular rigidity
Outflow facility coefficient	3-4 minutes measurement of outflow facility

Secondary Outcome Measures

Name	Time	Method
Pulsatile ocular blood flow	6 minutes
Ocular pulse amplitude	6 minutes

Trial Locations

Locations (1)

Ophthalmology Department, University Hospital of Larissa; 🇬🇷 Larissa, Greece