NCT02321722

Brief Summary

Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed and treated properly. The major risk factor for the development and progression of glaucoma is increased intraocular pressure. Colonoscopy is one of the most preformed world wide screening exam. It is used to detect colon cancer at its early stages. As part of this examination, the examiner inflates the inspected colon with air in order to increase the colon lumen for better visualization of the colon. As a consequence of the insufflation the intrabdominal pressure increases as well. the increase in intrabdominal pressure could increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure increase while preforming colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

December 17, 2014

Last Update Submit

May 8, 2018

Conditions

Intraocular Pressure

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Increase of Intraocular pressure

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population are healthy examinees, undergoing routine colonsocopy examination. All have no ocular disese and family history of glucoma.

You may qualify if:

  • Age \>18.
  • Patients referred by a gastroenterologist for a colonoscopy examination.
  • Patients the are interested in participating in this study and who are able to sign an informed consent.

You may not qualify if:

  • Family history of Glaucoma - first degree relatives.
  • Patients with known ocular disease, excluding refraction.
  • Patients receiving eye pharmacologic treatment.
  • Patients with known allergies to Oxybuprocaine Hydrochloride drops.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

IL(1)