Intraocular PressureNCT02321722
The Effect of Colonoscopy on Intralocular Pressure
An observational study of Intraocular Pressure, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population are healthy examinees, undergoing routine colonsocopy examination. All have no ocular disese and family history of glucoma.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Intraocular Pressure
- Keywords
- Colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of Intraocular pressure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilan Kent, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321722
- Sponsor's protocol ID
- MMC-0125-14
- Status last verified
- May 2018
- First submitted
- 17 Dec 2014
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colonoscopy on Intralocular Pressure
- ClinicalTrials.gov ID
- NCT02321722
- Acronym / sponsor ID
- MMC-0125-14
- Conditions
- Intraocular Pressure
- Keywords
- Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are healthy examinees, undergoing routine colonsocopy examination. All have no ocular disese and family history of glucoma.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase of Intraocular pressure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
Related trials for Intraocular Pressure
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of Intraocular pressure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.