NCT00083291

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

May 18, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2005

First QC Date

May 18, 2004

Last Update Submit

March 3, 2008

Conditions

Keywords

Dry EyesConjunctivaInfectionAntibodiesInflammationOcular Surface DiseaseHelicobacter Pylori

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 7549683BACKGROUND
  • 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. doi: 10.1016/s0161-6420(01)01031-4.

    PMID: 11927434BACKGROUND
  • 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. doi: 10.1001/archopht.121.4.478.

    PMID: 12695244BACKGROUND

MeSH Terms

Conditions

Helicobacter InfectionsDry Eye SyndromesInfectionsInflammation

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesLacrimal Apparatus DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations