NCT00570362

Brief Summary

The purpose of this study is to evaluate whether systemic glutathione level is decreased in patients with normal tension glaucoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 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

First Submitted

Initial submission to the registry

December 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 10, 2010

Completed
Last Updated

August 10, 2010

Status Verified

December 1, 2007

Enrollment Period

7 months

First QC Date

December 7, 2007

Results QC Date

June 11, 2010

Last Update Submit

July 14, 2010

Conditions

Keywords

Normal tension glaucomaGlutathioneAntioxidant

Outcome Measures

Primary Outcomes (1)

  • Total Glutathione Levels

    Subjects were instructed to fast from midnight to 8 AM on the morning of the test. All blood samples were obtained by a qualified registered nurse in the morning, between 8 and 10 AM.

    Once in the morning.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of tertiary referred center

You may qualify if:

  • Clinical Diagnosis of Normal Tension Glaucoma: Patients underwent diurnal IOP phasing and were diagnosed as having normal tension glaucoma(IOP always lesser than 22 mm Hg by applanation tonometry), glaucomatous optic disc cupping on fundoscopic examination, open anterior chamber angles by gonioscopy(Schaffer grade III or more), and repeatable VF defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer.
  • Must be able to provide intravenous blood sampling

You may not qualify if:

  • Narrow iridocorneal angles
  • Any evidence of secondary open-angle glaucoma
  • Any other ocular disease except cataract
  • History of previous intraocular surgery including cataract
  • Any other systemic disease except hypertension
  • The control group was composed of age-matched healthy volunteers who had neither glaucoma nor other ocular diseases such as cataract, diabetic retinopathy or age related macular degeneration. The control group did not show any glaucomatous optic disc cupping on fundoscopic examination or visual field defects with program 24-2 of the Humphrey Field Analyzer. The healthy volunteers in the control group must be able to provide intravenous blood sampling.
  • Smoking
  • History of any chronic systemic disease with presumed low glutathione levels, including autoimmune diseases, alcoholic liver disease, cancer, and diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine, The Catholic University of Korea, St. Mary's Hospital

Seoul, 150-713, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Results Point of Contact

Title
Jung-Il Moon
Organization
St.Mary's Hospital, College of Medicine, The Catholic University of Korea

Study Officials

  • Jung-Il Moon, Professor

    Department of Ophthalmology, St.Mary's Hospital, College of Medicine, The Catholic University of Korea

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 10, 2007

Study Start

March 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 10, 2010

Results First Posted

August 10, 2010

Record last verified: 2007-12

Locations