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The Effects of Virtual Colonoscopy on Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT03090243
Recruitment Status : Unknown
Verified March 2017 by Shlomo gavrielli, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Shlomo gavrielli, Rabin Medical Center

Brief Summary:
Our trial examined the intraocular pressure measurements differences, before and after virtual colonoscopy examination.

Condition or disease Intervention/treatment
Intraocular Pressure Disorder Device: Virtual colonoscopy

Detailed Description:

Glaucoma is a complicated disease in which damage to the optic nerve leads to progressive, irreversible vision loss. Glaucoma is the second leading cause of blindness and associated with elevated intraocular pressure (IOP) as a major risk factor.

IOP is influenced by many factors, including ethnicity, heredity, various chemical substances (existing body and external body like drugs), physical changes (postures, neural and vascular autoregulation) and more.

Virtual colonoscopy is a common screening test for the early detection and diagnosis of colon cancer. The test is performed by computed tomography (CT) after inflating the colon with carbon dioxide (CO2) gas. The procedure is performed by inserting a Foley catheter through the anus. As a result of gas inflating of the bowel, consequently, there is an increase in the abdominal pressure.

Raising intra-abdominal pressure may cause a rise in intraocular pressure. The aim of this research is to examine the changes in IOP before and after the virtual colonoscopy, with the aim to improve the understanding of the relationship between intra-abdominal pressure and IOP.

The study will include 100 patients, men and women, that are scheduled for virtual colonoscopy test both in a hospital and in ambulatory.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Virtual Colonoscopy on Intraocular Pressure
Estimated Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 28, 2018
Estimated Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Study Group
measurements of IOP before and after virtual colonoscopy
Device: Virtual colonoscopy
Inserting a Foley catheter through the anus, and gas inflating of the bowel.




Primary Outcome Measures :
  1. Intra ocular measurements differences [ Time Frame: 3 years ]
    Raising intra-abdominal pressure may cause a rise in intraocular pressure. The aim of this research is to examine the changes in IOP before and after the virtual colonoscopy, with the aim to improve the understanding of the relationship between intra-abdominal pressure and IOP.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients in the study include:

Participants: men and women. Age ≥ 18 years. directed by a gastroenterologist to examine colonoscopy for diagnosing colon pathology (either screening, follow-up routine or after surgery).

patients who want to participate which are able to understand and sign, an informed consent to participate in research.

Exclusion recruitment criteria:

Family History of Glaucoma first-degree relatives. patients suffering from known eye diseases, except for refractive disorders, strabismus or amblyopia, and do not take any eye care on a regular basis.

patients with a known allergy for Localin drops. patients who do not want to participate or are unable to understand or sign an informed consent to participate in research.

Exclusion criteria from the study: The researcher doctor may remove a participant from the study if he impressed, of strong health impairments resulting from the research.

Criteria

Inclusion Criteria:

  • Participants: men and women.
  • Age ≥ 18 years.
  • directed by a gastroenterologist to examine colonoscopy for diagnosing colon pathology (either screening, follow-up routine or after surgery).
  • patients who want to participate which are able to understand and sign, an informed consent to participate in research.

Exclusion Criteria:

  • Exclusion recruitment criteria:
  • Family History of Glaucoma first-degree relatives.
  • patients suffering from known eye diseases, except for refractive disorders, strabismus or amblyopia, and do not take any eye care on a regular basis.
  • patients with a known allergy for Localin drops.
  • patients who do not want to participate or are unable to understand or sign an informed consent to participate in research.

Exclusion criteria from the study:

  • The researcher doctor may remove a participant from the study if he impressed, of strong health impairments resulting from the research.

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Responsible Party: Shlomo gavrielli, Doctor of medicine, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03090243     History of Changes
Other Study ID Numbers: 0543-16-RMC
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shlomo gavrielli, Rabin Medical Center:
Glaucoma
Intraocular pressure
Colonoscopy
Virtual Colonoscopy
Valsalva