Central Corneal Thickness in Glaucoma

Exfoliation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023997
• Other study ID #: A3502
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: May 9, 2014
• Start date: January 2008
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 89 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exfoliation Syndrome

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central corneal thickness		Morning measurement (10:00-11:00)	No
Secondary	Visual field, scanning laser polarimetry		10:00-11:00	No