The Effects of Virtual Colonoscopy on Intraocular Pressure

NCT03090243 | Unknown FDA Device

• 1 other identifier: 0543-16-RMC
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intraocular Pressure Disorder

Keywords

Glaucoma; Intraocular pressure; Colonoscopy; Virtual Colonoscopy; Valsalva

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Group

measurements of IOP before and after virtual colonoscopy

Device: Virtual colonoscopy

Interventions

Virtual colonoscopy DEVICE

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shlomo gavrielli: lead

MeSH Terms

Conditions

Glaucoma

Interventions

Colonography, Computed Tomographic

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Diagnostic Techniques, Digestive System

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of medicine

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: April 1, 2017
• Primary Completion: March 28, 2018
• Study Completion: March 28, 2018
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share