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Early Diagnosis in Glaucoma With GDxVcc

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT01022281
Collaborator
(none)
82
Enrollment
1
Location
63
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    82 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Scanning Laser Polarimetry Findings in Individuals With Exfoliation Syndrome Compared With Normal Controls
    Study Start Date :
    Sep 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Normal Controls

    Normal age matched controls without exfoliation
    Exfoliation Syndrome

    Patients with exfoliation syndrome

    Outcome Measures

    Primary Outcome Measures

    1. Scanning laser polarimetry parameters, evaluation of retina nerve fiber layer thickness [Morning measurement (10:00 - 13:00)]

    Secondary Outcome Measures

    1. Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma [10:00-13:00]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glaucoma Unit, 1st University Department of Ophthalmology Thessaloniki Greece

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

    • Study Director: Antonios T Dimopoulos, MD, 1st University Department of Ophthalmogy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT01022281
    Other Study ID Numbers:
    • A3631
    First Posted:
    Dec 1, 2009
    Last Update Posted:
    May 12, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
    Exfoliation
    Scanning Laser Polarimetry
    Corneal Thickness
    Additional relevant MeSH terms:
    Exfoliation Syndrome
    Syndrome

    Study Results

    No Results Posted as of May 12, 2014