NCT01023997

Brief Summary

The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

5 years

First QC Date

December 1, 2009

Last Update Submit

May 9, 2014

Conditions

Exfoliation Syndrome

Keywords

corneal thicknessexfoliation

Outcome Measures

Primary Outcomes (1)

  • central corneal thickness

    Morning measurement (10:00-11:00)

Secondary Outcomes (1)

  • Visual field, scanning laser polarimetry

    10:00-11:00

Study Arms (4)

primary open-angle glaucoma

ocular hypertension patients

normal controls

Exfoliation patients

patients with exfoliation syndrome or exfoliative glaucoma

Eligibility Criteria

Age25 Years - 89 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 glaucomatous damage
  • Intraocular pressure above 21 mm Hg without glaucomatous damage
  • Raised intraocular pressure with glaucomatous damage

You may not qualify if:

  • Corneal disorders
  • History of trauma
  • Evidence of corneal abnormality that may influence IOP
  • Contact lens use
  • Corneal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, 546 36, Greece

Location

MeSH Terms

Conditions

Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye Diseases

Study Officials

  • Kostantinos Kaltsos, MD, PhD

    1st University Dept of Ophthalmology

    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

December 1, 2009

First Posted

December 2, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

GR(1)