The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 18, 2008 | ||||||||
| Last Updated Date | July 18, 2008 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients | ||||||||
| Official Title ICMJE | The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: After application of anethesia eyedrops, nitrocel membrane is put ocular surface. Then, removed the membrane. This method is commonly used clinically. |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | The dry eye patients at the clinic of Kyoto Prefectural University of Medicine hospital |
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| Condition ICMJE | Dry Eye Disease | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | March 2010 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00718926 | ||||||||
| Other Study ID Numbers ICMJE | C244 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jun Yamada MD. PhD., Meiji University of Oriental Medicine | ||||||||
| Study Sponsor ICMJE | Meiji University of Oriental Medicine | ||||||||
| Collaborators ICMJE | Kyoto Prefectural University of Medicine | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Meiji University of Oriental Medicine | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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