The Effects of Virtual Colonoscopy on Intraocular Pressure

NCT ID: NCT03090243

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-03-28

Brief Summary

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

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.

Conditions

Intraocular Pressure Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

measurements of IOP before and after virtual colonoscopy

Virtual colonoscopy

Intervention Type: DEVICE

Inserting a Foley catheter through the anus, and gas inflating of the bowel.

Interventions

Virtual colonoscopy

Inserting a Foley catheter through the anus, and gas inflating of the bowel.

Intervention Type: DEVICE

Eligibility 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shlomo gavrielli

OTHER

Sponsor Role: lead

Responsible Party

Shlomo gavrielli

Doctor of medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

0543-16-RMC

Identifier Type: -

Identifier Source: org_study_id