NCT00327509

Brief Summary

The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A secondary objective is to analyze the impact of different forms of glaucoma or of a vasospastic propensity on the findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

3.9 years

First QC Date

May 17, 2006

Last Update Submit

August 19, 2009

Conditions

Keywords

mRNAglaucoma

Study Arms (6)

1-HTG

high tension glaucoma highest IOP \> 21 mmHg

2-NTG

normal tension glaucoma highest measured IOP \< 21 mmHg

3-PEX

pseudoexfoliation glaucoma PEX material visible

4-Juvenile

juvenile glaucoma

5-Control1

healthy subjects (age group 1)

6-Control2

healthy subjects (age group 2)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

glaucoma patients, healthy subjects

You may qualify if:

  • Glaucoma patients
  • diagnosis of chronic glaucoma with typical glaucomatous disc and visual field damage
  • a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment HTG)
  • a present or past diurnal tension curve with an average intraocular pressure below 21 mmHg without treatment (NTG)
  • a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment and signs of pseudoexfoliation in the anterior segment (PEX)
  • a juvenile-onset open-angle glaucoma with a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment (Juvenile Glaucoma)
  • Healthy subjects
  • no history of ocular disease
  • no history of systemic disease
  • no history of alcohol/drug abuse
  • normal blood pressure (100-140 / 60-90 mmHg)
  • best corrected visual acuity above 20/25 in both eyes
  • no pathological findings upon a slit-lamp examination and indirect fundoscopy
  • IOP \< 20 mmHg in both eyes

You may not qualify if:

  • Ametropia \> 3 dpt
  • Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
  • Pigmentary dispersion
  • any abnormality which in the physician's view would prevent reliable applanation tonometry
  • History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis
  • History of ocular trauma or intraocular surgery within the past 6 months
  • History of infection or inflammation within the past 3 months
  • History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment
  • Need for any concomitant medications that may interfere with the evaluation of ocular blood flow
  • significant history and/or active alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Eye Clinic

Basel, Canton of Basel-City, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

white cells

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Selim Orgül, MD

    University Hospital, Basel, Switzerland

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

January 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations