Helicobacter Pylori and Dry Eye
Pilot Study of Helicobacter Pylori and Ocular Surface Disease
2 other identifiers
observational
10
1 country
1
Brief Summary
This study will examine whether infection with Helicobacter pylori bacteria may cause inflammation of the eye's surface. Although most people who are infected with H. pylori do not have symptoms, the bacteria can cause several diseases, including gastritis-stomach inflammation, stomach ulcers or, rarely, stomach cancer, and certain types of lymphoma. H. pylori has also been associated with autoimmune disorders, in which the patient's immune system attacks the body's own tissues. People who have been infected with H. pylori, with and without dry eye, may be eligible for this study. Candidates are screened with a medical history, a blood test to determine H. pylori infection, and an eye examination. The examination includes measurements of visual acuity, eye pressure, and tear production. To measure the amount of tear production, a small piece of filter paper is inserted over the eyelid on the side and collects tears over a 5-minute period. Drops of two colored dyes (orange and green) are placed in the eyes to see if there are any dry areas. Screening also includes examination of the pupils and eye movements, the lens, and the back of the eye, including the retina. Participants will also have a few cells collected from the surface of the eye. After the eyes are numbed with anesthetic eye drops, a swab (like a Q-tip) is rolled over the surface of the white part of the eye to collect small samples of the superficial layer of the conjunctiva - a transparent membrane covering the eyeball. The specimens are analyzed by special laboratory techniques to determine whether H. pylori has infected the eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2004
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 18, 2004
CompletedFirst Posted
Study publicly available on registry
May 18, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedMarch 4, 2008
March 1, 2005
May 18, 2004
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patients with ocular surface disease including aqueous or evaporative tear deficiency who are seropositive for H. pylori will be eligible. Controls will be adults without ocular surface disease who are seropositve for H. pylori.
You may not qualify if:
- None listed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Eye Institute (NEI)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Patel P, Mendall MA, Carrington D, Strachan DP, Leatham E, Molineaux N, Levy J, Blakeston C, Seymour CA, Camm AJ, et al. Association of Helicobacter pylori and Chlamydia pneumoniae infections with coronary heart disease and cardiovascular risk factors. BMJ. 1995 Sep 16;311(7007):711-4. doi: 10.1136/bmj.311.7007.711.
PMID: 7549683BACKGROUNDWeger M, Haas A, Stanger O, El-Shabrawi Y, Temmel W, Maier R, Berghold A, Haller-Schober EM. Chlamydia pneumoniae seropositivity and the risk of nonarteritic ischemic optic neuropathy. Ophthalmology. 2002 Apr;109(4):749-52. doi: 10.1016/s0161-6420(01)01031-4.
PMID: 11927434BACKGROUNDKalayoglu MV, Galvan C, Mahdi OS, Byrne GI, Mansour S. Serological association between Chlamydia pneumoniae infection and age-related macular degeneration. Arch Ophthalmol. 2003 Apr;121(4):478-82. doi: 10.1001/archopht.121.4.478.
PMID: 12695244BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 18, 2004
First Posted
May 18, 2004
Study Start
May 1, 2004
Study Completion
March 1, 2005
Last Updated
March 4, 2008
Record last verified: 2005-03