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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
  Purpose

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.


Condition Intervention Phase
Central Serous Chorioretinopathy
 Drug: omeprazole, Amoxicillin, metronidazole
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • Subretinal fluid level [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time of sub macular fluid absorption [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2008
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule
 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
No Intervention: 2
No medical 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.

  Eligibility

Ages Eligible for Study:   28 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817245

Locations
Iran, Islamic Republic of
Alireza JavadzadehTabriz
Tabriz, Iran, Islamic Republic of
Sponsors and Collaborators
Tabriz University
Investigators
Study Chair: Alireza Javadzadeh Alireza Javadzadeh
  More Information

No publications provided

Responsible Party: Alireza Javadzadeh, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00817245     History of Changes
Other Study ID Numbers: 86-47
Study First Received: January 1, 2009
Last Updated: January 5, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Tabriz University:
CSR
Helicobacter pylori

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Amoxicillin
Metronidazole
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013