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
Recruitment status was Recruiting
Sponsor:
Larissa University Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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
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 |
More Information
Publications:
| Responsible Party: | Ioannis Pallikaris, University of Crete |
| ClinicalTrials.gov Identifier: | NCT01315340 History of Changes |
| Other Study ID Numbers: | 8068 |
| Study First Received: | March 9, 2011 |
| Last Updated: | March 16, 2011 |
| Health Authority: | Greece: National Organization of Medicines |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013