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Systemic Glutathione Level in Normal Tension Glaucoma

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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

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition Normal Tension Glaucoma
Enrollment 49
Recruitment Details Patients with normal tension glaucoma attending the glaucoma clinic of the Catholic Eye Center at the St. Mary’ Hospital (Seoul, Korea) between June 2008 and October 2008, were recruited for this study. The control group was recruited from other age-gender-matched volunteers.
Pre-assignment Details Only subjects who voluntarily wanted to participate in this study were recruited.
Arm/Group Title Normal Tension Glaucoma Group Control Group
Hide Arm/Group Description Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA). The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
Period Title: Overall Study
Started 19 30
Completed 19 30
Not Completed 0 0
Arm/Group Title Normal Tension Glaucoma Group Control Group Total
Hide Arm/Group Description Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA). The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration. Total of all reporting groups
Overall Number of Baseline Participants 19 30 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 30 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  78.9%
29
  96.7%
44
  89.8%
>=65 years
4
  21.1%
1
   3.3%
5
  10.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 30 participants 49 participants
56.26  (8.48) 52.70  (6.70) 54.08  (7.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 30 participants 49 participants
Female
9
  47.4%
10
  33.3%
19
  38.8%
Male
10
  52.6%
20
  66.7%
30
  61.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 19 participants 30 participants 49 participants
19 30 49
1.Primary Outcome
Title Total Glutathione Levels
Hide Description 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.
Time Frame Once in the morning.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Tension Glaucoma Group Control Group
Hide Arm/Group Description:
Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
Overall Number of Participants Analyzed 19 30
Mean (Standard Deviation)
Unit of Measure: nmol
524.02  (231.09) 586.06  (156.08)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Tension Glaucoma Group Control Group
Hide Arm/Group Description Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA). The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
All-Cause Mortality
Normal Tension Glaucoma Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Tension Glaucoma Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normal Tension Glaucoma Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jung-Il Moon
Organization: St.Mary's Hospital, College of Medicine, The Catholic University of Korea
Phone: 82-2-3779-2114 ext 1243
EMail: jimoon@catholic.ac.kr
Layout table for additonal information
Responsible Party: Jung-Il Moon, St.Mary's Hospital, College of Medicine, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT00570362     History of Changes
Other Study ID Numbers: Merck-001
CMCEYE-GSH
First Submitted: December 7, 2007
First Posted: December 10, 2007
Results First Submitted: June 11, 2010
Results First Posted: August 10, 2010
Last Update Posted: August 10, 2010