- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817245
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR) (ICSCR)
January 5, 2009 updated by: Tabriz University
Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)
Etiology of ICSCR is not known however recent studies regard the role of immunologic and infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have positive effect on the remission of ICSCR.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
we will choose 50 cases of patients with ICSCR who are infected with h.pylori.25 cases will receive anti h.pylori regiment and 25 cases as controls will receive no medication.then
we will compare the time of submacular fluid resorption and macular thickness and visual acuity among these two groups.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tabriz, Iran, Islamic Republic of
- Alireza JavadzadehTabriz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the persons who are infected with helicobacter pylori and have ICSCR
Exclusion Criteria:
- history of previous eye surgery ,to have indication of laser therapy,corticosteroid therapy,pregnancy,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule
|
we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR
Other Names:
|
No Intervention: 2
No medical treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Subretinal fluid level
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Secondary Outcome Measures
Outcome Measure |
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time of sub macular fluid absorption
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Alireza Javadzadeh, Alireza Javadzadeh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
January 1, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 6, 2009
Study Record Updates
Last Update Posted (Estimate)
January 6, 2009
Last Update Submitted That Met QC Criteria
January 5, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Diseases
- Central Serous Chorioretinopathy
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Metronidazole
- Amoxicillin
- Omeprazole
Other Study ID Numbers
- 86-47
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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