Back to resultsEffect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR) (ICSCR)
Primary Purpose
Central Serous Chorioretinopathy
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
omeprazole, Amoxicillin, metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring CSR, Helicobacter pylori
Eligibility Criteria
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,
Sites / Locations
- Alireza JavadzadehTabriz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule
No medical treatment
Outcomes
Primary Outcome Measures
Subretinal fluid level
Secondary Outcome Measures
time of sub macular fluid absorption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00817245
Brief Title
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)
Acronym
ICSCR
Official Title
Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tabriz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
CSR, Helicobacter pylori
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule
Arm Title
2
Arm Type
No Intervention
Arm Description
No medical treatment
Intervention Type
Drug
Intervention Name(s)
omeprazole, Amoxicillin, metronidazole
Other Intervention Name(s)
treatment of Central serous chorioretinopathy
Intervention Description
we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR
Primary Outcome Measure Information:
Title
Subretinal fluid level
Secondary Outcome Measure Information:
Title
time of sub macular fluid absorption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Javadzadeh
Organizational Affiliation
Alireza Javadzadeh
Official's Role
Study Chair
Facility Information:
Facility Name
Alireza JavadzadehTabriz
City
Tabriz
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)
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