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The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Meiji University of Oriental Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Kyoto Prefectural University of Medicine
Information provided by:
Meiji University of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00718926
First received: July 18, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

Dry eye disease is related with oxidative stress at the ocular surface. GSH is one of the key factor of protect from oxidative stress. To evaluate thiol status of ocular surface cells by monitoring GSH concentration, we can evaluate the severity of dry eye.


Condition
Dry Eye Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients

Resource links provided by NLM:


Further study details as provided by Meiji University of Oriental Medicine:

Primary Outcome Measures:
  • Tear amount, tear break up time, and so on are measured clinically. The thiol redox status is measured by staining the membrane. [ Time Frame: Once a month (totally 2-4 times) at the clinic ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

After application of anethesia eyedrops, nitrocel membrane is put ocular surface. Then, removed the membrane. This method is commonly used clinically.


Estimated Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sjogren
Sjogren syndrome with dry eye
non-Sjogren
dry eye without Sjogren syndrome
Short-BUT
Dry eye by shortened tear break up time
control
normal patients

Detailed Description:

The conjunctival cells are collected by impression cytology. Those cells are stained with 100 mM of monochlorobimane (MCB, M-1381, Molecular Probes, Eugene, OR) and propidium iodide (PI). Fluorescent intensity, reflecting the amount of icGSH, was inspected under a confocal laser scan microscope. To detect the GSH levels we used a fluorescent MCB probe with excitation and emission wavelengths of 405 nm and 410-480 nm, respectively. The cell-permeating MCB probe is non-fluorescent but forms a fluorescent adduct with GSH in a reaction catalyzed by glutathione-S-transferase.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The dry eye patients at the clinic of Kyoto Prefectural University of Medicine hospital

Criteria

Inclusion Criteria:

  • dry eye patients
  • control volunteers

Exclusion Criteria:

  • Young (less than 20) patients
  • The patients who rejected this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718926

Contacts
Contact: Jun Yamada, MD, PhD. +81-75-251-5663 jyamada@koto.kpu-m.ac.jp
Contact: Norihiko Yokoi, MD, PhD. +81-75-251-5663 nyokoi@koto.kpu-m.ac.jp

Locations
Japan
Kyoto Prefectural University of Medicine hospital Recruiting
Kyoto, Japan
Contact: Shigeru Kinoshita, MD, PhD.    +81-75-251-5577    shigeruk@koto.kpu-m.ac.jp   
Sponsors and Collaborators
Meiji University of Oriental Medicine
Kyoto Prefectural University of Medicine
  More Information

No publications provided

Responsible Party: Jun Yamada MD. PhD., Meiji University of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00718926     History of Changes
Other Study ID Numbers: C244
Study First Received: July 18, 2008
Last Updated: July 18, 2008
Health Authority: Japan: Institutional Review Board

Keywords provided by Meiji University of Oriental Medicine:
dry eye
Thiol redox
Oxidative stress

Additional relevant MeSH terms:
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on November 23, 2014