Early Diagnosis in Glaucoma With GDxVcc

Exfoliation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022281
• Other study ID #: A3631
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: May 9, 2014
• Start date: September 2007
• Est. completion date: December 2012

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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

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	Scanning laser polarimetry parameters, evaluation of retina nerve fiber layer thickness		Morning measurement (10:00 - 13:00)	No
Secondary	Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma		10:00-13:00	No