NCT00804063

Brief Summary

Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

4 years

First QC Date

December 5, 2008

Last Update Submit

January 7, 2015

Conditions

Glaucoma

Keywords

glaucomacitrate

Outcome Measures

Primary Outcomes (1)

  • serum citrate level

    1

Secondary Outcomes (1)

  • urine citrate

    1

Study Arms (2)

1

glaucoma patients

Procedure: drawing blood sample

2

non-glaucoma controls

Procedure: drawing blood sample

Interventions

drawing blood samplePROCEDURE

fasting blood sample

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

tertiary university center

You may qualify if:

  • age\> 18 years
  • glaucoma

You may not qualify if:

  • Active ocular inflammation
  • Ocular Hypertension
  • Nephropathy
  • Alcohol-, Drug abuse
  • Mitochondriopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, serum, aqueous

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • David Goldblum, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Josef Flammer, MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

  • Selim Orguel, MD

    University Hospital, Basel, Switzerland

    STUDY DIRECTOR

  • Stephan Fraenkl, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Fabrizio Branca, MD

    University Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

CH(1)