Early Diagnosis in Glaucoma With GDxVcc

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01022281

Enrollment

Registered

2009-12-01

Start date

2007-09-30

Completion date

2012-12-31

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exfoliation Syndrome

Keywords

Exfoliation, Scanning Laser Polarimetry, Corneal Thickness

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Greece

Outcome results