Trial Outcomes & Findings for Systemic Glutathione Level in Normal Tension Glaucoma (NCT NCT00570362)
NCT ID: NCT00570362
Last Updated: 2010-08-10
Results Overview
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.
COMPLETED
49 participants
Once in the morning.
2010-08-10
Participant Flow
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.
Only subjects who voluntarily wanted to participate in this study were recruited.
Participant milestones
| Measure |
Normal Tension Glaucoma Group
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).
|
Control Group
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 Study
STARTED
|
19
|
30
|
|
Overall Study
COMPLETED
|
19
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Systemic Glutathione Level in Normal Tension Glaucoma
Baseline characteristics by cohort
| Measure |
Normal Tension Glaucoma Group
n=19 Participants
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).
|
Control Group
n=30 Participants
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
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
56.26 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
52.70 years
STANDARD_DEVIATION 6.70 • n=7 Participants
|
54.08 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
19 participants
n=5 Participants
|
30 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Normal Tension Glaucoma Group
n=19 Participants
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).
|
Control Group
n=30 Participants
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 Glutathione Levels
|
524.02 nmol
Standard Deviation 231.09
|
586.06 nmol
Standard Deviation 156.08
|
Adverse Events
Normal Tension Glaucoma Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jung-Il Moon
St.Mary's Hospital, College of Medicine, The Catholic University of Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place