Central Corneal Thickness in Glaucoma

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Completed

CT.gov ID

NCT01023997

Collaborator

(none)

700

Enrollment

Location

Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Exfoliation Syndrome

Detailed Description

To compare the central corneal thickness measurement in patients with exfoliation, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma. Prospective study in progress. Randomly selected patients undergo a comprehensive ophthalmic exam which includes 2 separate pachymetry measurements in 2 different examinations at the same time of the day (10:00 am) with 3 different pachymeters. The values obtained are correlated with a number of other glaucoma parameters. A thinner cornea may represent a specific attribute and an additional risk factor for patients with exfoliation. Evaluation of corneal thickness is an important exam in the management of patients with exfoliation.

Study Design

Study Type:

Observational

Actual Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Central Corneal Thickness in Patients With Exfoliation Syndrome, Exfoliative Glaucoma, Exfoliative Glaucoma, Primary Open-angle Glaucoma and Ocular Hypertension

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
primary open-angle glaucoma
ocular hypertension patients
normal controls
Exfoliation patients patients with exfoliation syndrome or exfoliative glaucoma

Outcome Measures

Primary Outcome Measures

central corneal thickness [Morning measurement (10:00-11:00)]

Secondary Outcome Measures

Visual field, scanning laser polarimetry [10:00-11:00]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Exfoliation material on pupil
Intraocular pressure below 21 mm Hg without glaucomatous damage
Intraocular pressure above 21 mm Hg without glaucomatous damage
Raised intraocular pressure with glaucomatous damage

Exclusion Criteria:

Corneal disorders
History of trauma
Evidence of corneal abnormality that may influence IOP
Contact lens use
Corneal surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki		Greece	546 36

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Investigators

Study Director: Kostantinos Kaltsos, MD, PhD, 1st University Dept of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT01023997

Other Study ID Numbers:

A3502

First Posted:

Dec 2, 2009

Last Update Posted:

May 12, 2014

Last Verified:

May 1, 2014

Keywords provided by AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki

corneal thickness

exfoliation

Additional relevant MeSH terms:

Glaucoma

Exfoliation Syndrome

Syndrome

Study Results

No Results Posted as of May 12, 2014