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OpenTrials
Completed

NCT Number: NCT01022281

Early Diagnosis in Glaucoma With GDxVcc

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

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Scanning laser polarimetry parameters, evaluation of retina nerve fiber layer thickness

    Time frame: Morning measurement (10:00 - 13:00)

Secondary outcomes

  1. Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma

    Time frame: 10:00-13:00

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Dec 1, 2009
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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