Helicobacter Infections Clinical Trial
Official title:
Pilot Study of Helicobacter Pylori and Ocular Surface Disease
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: None listed. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Eye Institute (NEI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Kalayoglu 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. — View Citation
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. Erratum in: BMJ 1995 Oct 14;311(7011):985. — View Citation
Weger 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. — View Citation
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