Normal Tension GlaucomaNCT00570362
Systemic Glutathione Level in Normal Tension Glaucoma
An observational study of Normal Tension Glaucoma, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether systemic glutathione level is decreased in patients with normal tension glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Tension Glaucoma
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Oct 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients of tertiary referred center
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
College of Medicine, The Catholic University of Korea, St. Mary's Hospital
Seoul, 150-713
About this study
Official title: Evaluation of Systemic Glutathione Level in Patients With Normal Tension Glaucoma
The purpose of this study is to evaluate whether systemic glutathione level is decreased in patients with normal tension glaucoma.
Read the 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).
- Conditions
- Normal Tension Glaucoma
- Keywords
- Normal tension glaucoma, Glutathione, Antioxidant
- Medical subject headings
- Low Tension Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once in the morning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Jung-Il Moon, Professor, Study director, Department of Ophthalmology, St.Mary's Hospital, College of Medicine, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570362
- Sponsor's protocol ID
- Merck-001
- Other IDs
- CMCEYE-GSH
- Status last verified
- Dec 2007
- First submitted
- 7 Dec 2007
- Last updated
- 10 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Glutathione Level in Patients With Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT00570362
- Acronym / sponsor ID
- Merck-001
- Conditions
- Normal Tension Glaucoma
- Keywords
- Normal tension glaucoma, Glutathione, Antioxidant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Dec 2007 (estimated)
- Results
- Posted 10 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients of tertiary referred center
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Normal Tension Glaucoma
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Active, not recruitingPhase 2
Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
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Active, not recruiting
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Il Moon, Professor study director
Department of Ophthalmology, St.Mary's Hospital, College of Medicine, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Tension Glaucoma, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Glutathione Levels (time frame: Once in the morning.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.