NCT01022281

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

3.3 years

First QC Date

November 30, 2009

Last Update Submit

May 9, 2014

Conditions

Exfoliation Syndrome

Keywords

ExfoliationScanning Laser PolarimetryCorneal Thickness

Outcome Measures

Primary Outcomes (1)

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

    Morning measurement (10:00 - 13:00)

Secondary Outcomes (1)

  • Corneal thickness, exfoliation syndrome subjects that will develop exfoliation glaucoma

    10:00-13:00

Study Arms (2)

Normal Controls

Normal age matched controls without exfoliation

Exfoliation Syndrome

Patients with exfoliation syndrome

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with and without exfoliation

You may qualify if:

  • Exfoliation material on pupil
  • Intraocular pressure below 21 mm Hg without therapy
  • No glaucomatous damage
  • Age between 60-75
  • Open angle

You may not qualify if:

  • Other Ophthalmic diseases
  • Dry eye
  • Corneal disorders
  • Diabetic Retinopathy
  • Optic Neuropathy (other than glaucomatous neuropathy)
  • Ocular surgery or laser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye Diseases

Study Officials

  • Antonios T Dimopoulos, MD

    1st University Department of Ophthalmogy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Ophthalmology

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

September 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)