Intraocular Pressure DisorderNCT03090243
The Effects of Virtual Colonoscopy on Intraocular Pressure
An observational study of Intraocular Pressure Disorder, run by Shlomo gavrielli.
Trial summary
Our trial examined the intraocular pressure measurements differences, before and after virtual colonoscopy examination. 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 Disorder
- What is being tested?
- Virtual colonoscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 28 Mar 2018
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Our trial examined the intraocular pressure measurements differences, before and after virtual colonoscopy examination.
Read the 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
- Being tested
- Virtual colonoscopy
- Keywords
- Glaucoma, Intraocular pressure, Colonoscopy, Virtual Colonoscopy, Valsalva
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual colonoscopyDevice
Inserting a Foley catheter through the anus, and gas inflating of the bowel.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | measurements of IOP before and after virtual colonoscopy Receives: Device: Virtual colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Apr 2017 (estimated)
- Primary completion28 Mar 2018 (estimated)
- Study completion28 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure DisorderStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shlomo gavrielli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shlomo gavrielli, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090243
- Sponsor's protocol ID
- 0543-16-RMC
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: there is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Colonoscopy on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT03090243
- Acronym / sponsor ID
- 0543-16-RMC
- Conditions
- Intraocular Pressure Disorder
- Keywords
- Glaucoma, Intraocular pressure, Colonoscopy, Virtual Colonoscopy, Valsalva
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shlomo gavrielliUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 28 Mar 2018 (estimated)
- Study completion
- 28 Mar 2018 (estimated)
- First posted
- 24 Mar 2017 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Virtual colonoscopymeasurements of IOP before and after virtual colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual colonoscopyInserting a Foley catheter through the anus, and gas inflating of the bowel. | Device | Study Group |
Primary outcome
Intra ocular measurements differences
Time frame: 3 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Individual participant dataSharing planned: No. there is no plan to share individual participant data
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure Disorder, run by Shlomo gavrielli.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Intra ocular measurements differences (time frame: 3 years). 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 28 Mar 2017.