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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Systemic Glutathione Level in Normal Tension Glaucoma

NCTNCT00570362 (opens ClinicalTrials.gov in a new tab)Other idMerck-001Other idCMCEYE-GSH
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glutathione, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
49 participants (actual)
Sponsor
The Catholic University of Korea · Other
Design
Not stated
Countries
1 country

South Korea

Start
Mar 2008
Primary completion
Oct 2008
Completion
Oct 2008
First posted
10 Dec 2007 (estimated)
Last update posted
10 Aug 2010 (estimated)
Conditions
Normal Tension Glaucoma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph –

    Systemic Glutathione Level in Normal Tension Glaucoma

    NCT00570362

    Mar 2008 to Oct 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate whether systemic glutathione level is decreased in patients with normal tension glaucoma.

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total Glutathione Levels

    Time frame · Once in the morning.

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Once in the morning.

Total Glutathione Levels

GroupValue (nmol)Spread
Normal Tension Glaucoma Group524.02231.09
Control Group586.06156.08

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Normal Tension Glaucoma GroupPatients 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).–0 / 190 / 19
Control GroupThe 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.–0 / 300 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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