- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02321722
The Effect of Colonoscopy on Intralocular Pressure
May 8, 2018 updated by: Ilan Kent, Meir Medical Center
Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed and treated properly.
The major risk factor for the development and progression of glaucoma is increased intraocular pressure.
Colonoscopy is one of the most preformed world wide screening exam.
It is used to detect colon cancer at its early stages.
As part of this examination, the examiner inflates the inspected colon with air in order to increase the colon lumen for better visualization of the colon.
As a consequence of the insufflation the intrabdominal pressure increases as well.
the increase in intrabdominal pressure could increase intraocular pressure.
The aim of this study is to evaluate the intraocular pressure increase while preforming colonoscopy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kfar Saba, Israel
- Meir Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population are healthy examinees, undergoing routine colonsocopy examination.
All have no ocular disese and family history of glucoma.
Description
Inclusion Criteria:
- Age >18.
- Patients referred by a gastroenterologist for a colonoscopy examination.
- Patients the are interested in participating in this study and who are able to sign an informed consent.
Exclusion Criteria:
- Family history of Glaucoma - first degree relatives.
- Patients with known ocular disease, excluding refraction.
- Patients receiving eye pharmacologic treatment.
- Patients with known allergies to Oxybuprocaine Hydrochloride drops.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase of Intraocular pressure
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
December 17, 2014
First Submitted That Met QC Criteria
December 19, 2014
First Posted (Estimate)
December 22, 2014
Study Record Updates
Last Update Posted (Actual)
May 9, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MMC-0125-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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