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Trial record 3 of 83 for:    PEELING SKIN SYNDROME

Early Diagnosis in Glaucoma With GDxVcc

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ClinicalTrials.gov Identifier: NCT01022281
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
AGP Konstas, 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

Condition or disease
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.

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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 : September 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


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



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

Secondary Outcome Measures :
  1. Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma [ Time Frame: 10:00-13:00 ]


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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals with and without exfoliation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022281


Locations
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Greece
Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Study Director: Antonios T Dimopoulos, MD 1st University Department of Ophthalmogy

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Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01022281     History of Changes
Other Study ID Numbers: A3631
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by AGP Konstas, Aristotle University Of Thessaloniki:
Exfoliation
Scanning Laser Polarimetry
Corneal Thickness

Additional relevant MeSH terms:
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Syndrome
Exfoliation Syndrome
Disease
Pathologic Processes
Iris Diseases
Uveal Diseases
Eye Diseases