The Effects of Virtual Colonoscopy on Intraocular Pressure

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

Study Overview

• Status: Unknown
• Conditions: Intraocular Pressure Disorder
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra ocular measurements differences	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.	3 years

Collaborators and Investigators

• Sponsor: Shlomo gavrielli

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): March 28, 2018
• Study Completion (Anticipated): March 28, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 25, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Intraocular pressure; Colonoscopy; Glaucoma; Virtual Colonoscopy; Valsalva
• Other Study ID Numbers: 0543-16-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: there is no plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No