Early Diagnosis in Glaucoma With GDxVcc

Evaluation of Scanning Laser Polarimetry Findings in Individuals With Exfoliation Syndrome Compared With Normal Controls

To compare the Retina Nerve Fiber Layer thickness, measured with Scanning Laser Polarimetry in subjects with exfoliation syndrome and normal controls and to evaluate the value of scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma

Study Overview

• Status: Completed
• Conditions: Exfoliation Syndrome

Detailed Description

To compare the Scanning Laser Polarimetry findings in subjects with exfoliation syndrome and normal controls and to evaluate the value of scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma. Prospective study in progress. The investigators compare and analyze the scanning laser polarimetry parameters in consecutive subjects with exfoliation syndrome and normal intraocular pressure and compared them with consecutive normal controls. Randomly selected patients with exfoliation syndrome and normal controls undergo a comprehensive ophthalmic exam which includes 3 IOP measurements, corneal pachymetry, automated perimetry and assessment of the retina nerve fiber layer with scanning laser polarimetry. The investigators hypothesize that patients with exfoliation syndrome may show worse scanning laser polarimetry parameters than normal controls and this may prove to be an early sign of exfoliative glaucoma development. Evaluation of retina nerve fiber layer thickness may help us in identifying earlier those individuals with exfoliation syndrome that will develop exfoliative glaucoma.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Glaucoma Unit, 1st University Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals with and without exfoliation

Description

Inclusion Criteria:

• Exfoliation material on pupil
• Intraocular pressure below 21 mm Hg without therapy
• No glaucomatous damage
• Age between 60-75
• Open angle

Exclusion Criteria:

• Other Ophthalmic diseases
• Dry eye
• Corneal disorders
• Diabetic Retinopathy
• Optic Neuropathy (other than glaucomatous neuropathy)
• Ocular surgery or laser

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Normal Controls; Normal age matched controls without exfoliation
Exfoliation Syndrome; Patients with exfoliation syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Scanning laser polarimetry parameters, evaluation of retina nerve fiber layer thickness	Morning measurement (10:00 - 13:00)

Secondary Outcome Measures

Outcome Measure	Time Frame
Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma	10:00-13:00

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Director: Antonios T Dimopoulos, MD, 1st University Department of Ophthalmogy

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 1, 2009

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Exfoliation; Scanning Laser Polarimetry; Corneal Thickness
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Uveal Diseases; Iris Diseases; Syndrome; Exfoliation Syndrome
• Other Study ID Numbers: A3631