Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Systemic Glutathione Level in Normal Tension Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00570362
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : August 10, 2010
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
The Catholic University of Korea

Tracking Information
First Submitted Date December 7, 2007
First Posted Date December 10, 2007
Results First Submitted Date June 11, 2010
Results First Posted Date August 10, 2010
Last Update Posted Date August 10, 2010
Study Start Date March 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2010)
Total Glutathione Levels [ Time Frame: Once in the morning. ]
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00570362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Systemic Glutathione Level in Normal Tension Glaucoma
Official Title Evaluation of Systemic Glutathione Level in Patients With Normal Tension Glaucoma
Brief Summary The purpose of this study is to evaluate whether systemic glutathione level is decreased in patients with normal tension glaucoma.
Detailed Description

Normal tension glaucoma is one of the most common cause of primary open angle glaucoma in Korea. Even though, we still do not know what the cause is. Only IOP-lowering drugs are the currently available therapeutic method. Glutathione is one of the mostly high concentrated intracellular antioxidants. We find apoptosis of neuronal cell in the mouse retina by systemic depletion of glutathione using buthionine sulfoximine. Glutathione is also known to be reduced in primary open angle glaucoma with high IOP. So we are planning to evaluate systemic glutathione level in normal tension glaucoma.

Blood samples will be obtained by venipuncture to the antecubital vein of normal tension glaucoma patients and age-matched normal controls. Five milliliters of blood will be collected in EDTA-treated tubes (to prevent oxidation). Thirty microliters of blood will be then transferred into centrifuge tubes, and will be added 33.3 microliter of 5-sulfosalicylic acid (SSA), 100mg/mL within 10 minutes from the blood collection.Each sample will be then diluted with 936.7 microliter sodium phosphate buffer (pH 7.5), and the content of each tube will be mixed rapidly in a centrifuge at 13,000 rpm for 5 minutes. A portion of supernatant (150 microliter) will be then collected into clean centrifuge tubes and immediately cooled at -70°C. To each well of a 96-well plate, 150 microliter of daily buffer (3 mg NADPH into 10 mL sodium phosphate buffer), 50microliter of DTNB solution, and 25 microliter of standards or samples will be added in quadruplicate, and the plate will be incubated at 37 °C for 3 minutes.Finally, 25 microliter GSSGR will be added to the previous mixture, and the plate will be read at 410 nm using a 96-well plate reader(UV spectrophotometer).

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum
Sampling Method Non-Probability Sample
Study Population patients of tertiary referred center
Condition Normal Tension Glaucoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2010)
49
Original Estimated Enrollment
 (submitted: December 7, 2007)
60
Actual Study Completion Date October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Patients were included in the normal tension glaucoma group according to the following criteria.

Inclusion Criteria (normal tension glaucoma group):

  • 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

Exclusion Criteria (normal tension glaucoma group):

  • 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.

Exclusion criteria for both groups:

  • Smoking
  • History of any chronic systemic disease with presumed low glutathione levels, including autoimmune diseases, alcoholic liver disease, cancer, and diabetes mellitus.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00570362
Other Study ID Numbers Merck-001
CMCEYE-GSH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jung-Il Moon, St.Mary's Hospital, College of Medicine, The Catholic University of Korea
Study Sponsor The Catholic University of Korea
Collaborators Not Provided
Investigators
Study Director: Jung-Il Moon, Professor Department of Ophthalmology, St.Mary's Hospital, College of Medicine, The Catholic University of Korea
PRS Account The Catholic University of Korea
Verification Date December 2007