Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)

This study has been completed.

Sponsor:

Information provided by:

Tabriz University

ClinicalTrials.gov Identifier:

NCT00817245

First received: January 1, 2009

Last updated: January 5, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 1, 2009

Last Updated Date

January 5, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Subretinal fluid level [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00817245 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

time of sub macular fluid absorption [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)

Official Title ^ICMJE

Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Central Serous Chorioretinopathy

Intervention ^ICMJE

Drug: omeprazole, Amoxicillin, metronidazole

we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR

Other Name: treatment of Central serous chorioretinopathy

Study Arm (s)

Active Comparator: 1
Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule

Intervention: Drug: omeprazole, Amoxicillin, metronidazole
No Intervention: 2
No medical treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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,

Gender

Both

Ages

28 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT00817245

Other Study ID Numbers ^ICMJE

86-47

Has Data Monitoring Committee

Yes

Responsible Party

Alireza Javadzadeh, Tabriz University of Medical Sciences

Study Sponsor ^ICMJE

Tabriz University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Alireza Javadzadeh

Information Provided By

Tabriz University

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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