Early Diagnosis in Glaucoma With GDxVcc

NCT ID: NCT01022281

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Exfoliation Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal Controls

Normal age matched controls without exfoliation

No interventions assigned to this group

Exfoliation Syndrome

Patients with exfoliation syndrome

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

AGP Konstas

Professor in Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonios T Dimopoulos, MD

Role: STUDY_DIRECTOR

1st University Department of Ophthalmogy

Locations

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

A3631

Identifier Type: -

Identifier Source: org_study_id