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Systemic Glutathione Level in Normal Tension Glaucoma

Evaluation of Systemic Glutathione Level in Patients With Normal Tension Glaucoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00570362
Enrollment
49
Registered
2007-12-10
Start date
2008-03-31
Completion date
2008-10-31
Last updated
2010-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Tension Glaucoma

Keywords

Normal tension glaucoma, Glutathione, Antioxidant

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).

Interventions

None listed

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Total Glutathione LevelsOnce 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.

Countries

South Korea

Participant flow

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.

Participants by arm

ArmCount
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).
19
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.
30
Total49

Baseline characteristics

CharacteristicControl GroupNormal Tension Glaucoma GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants4 Participants5 Participants
Age, Categorical
Between 18 and 65 years
29 Participants15 Participants44 Participants
Age Continuous52.70 years
STANDARD_DEVIATION 6.7
56.26 years
STANDARD_DEVIATION 8.48
54.08 years
STANDARD_DEVIATION 7.43
Region of Enrollment
Korea, Republic of
30 participants19 participants49 participants
Sex: Female, Male
Female
10 Participants9 Participants19 Participants
Sex: Female, Male
Male
20 Participants10 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 190 / 30
serious
Total, serious adverse events
0 / 190 / 30

Outcome results

Primary

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.

Time frame: Once in the morning.

ArmMeasureValue (MEAN)Dispersion
Normal Tension Glaucoma GroupTotal Glutathione Levels524.02 nmolStandard Deviation 231.09
Control GroupTotal Glutathione Levels586.06 nmolStandard Deviation 156.08

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026