The Effects of Virtual Colonoscopy on Intraocular Pressure

Intraocular Pressure Disorder Clinical Trial

Official title:

The Effects of Virtual Colonoscopy on Intraocular Pressure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03090243
• Other study ID #: 0543-16-RMC
• Status: Not yet recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 25, 2017
• Start date: April 1, 2017
• Est. completion date: March 28, 2018

Study information

• Verified date: March 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 28, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Pressure Disorder

Intervention

Device:
• Virtual colonoscopy
Inserting a Foley catheter through the anus, and gas inflating of the bowel.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shlomo gavrielli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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