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Ocular Rigidity and Outflow Facility in Glaucomatous and Normal Eyes

Measurement of Ocular Rigidity, Outflow Facility and Ocular Blood Flow in Glaucomatous and Normal Eyes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01315340
Enrollment
50
Registered
2011-03-15
Start date
2011-03-31
Completion date
2024-07-31
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

PROCEDUREOcular 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.

Sponsors

University of Crete
CollaboratorOTHER
Larissa University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Ocular rigidity coefficient2 minutes measurement of ocular rigidity
Outflow facility coefficient3-4 minutes measurement of outflow facility

Secondary

MeasureTime frame
Ocular pulse amplitude6 minutes
Pulsatile ocular blood flow6 minutes

Countries

Greece

Contacts

Primary ContactIoannis Pallikaris, MD
ioanpall@gmail.com2810392351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026