Early Diagnosis in Glaucoma With GDxVcc

Completed

• Conditions: Exfoliation Syndrome

• Registration Number: NCT01022281
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2010-12
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma	10:00-13:00

Trial Locations

Locations (1)

Glaucoma Unit, 1st University Department of Ophthalmology; 🇬🇷 Thessaloniki, Greece