Intraocular PressureNCT02646033
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
An observational study of Intraocular Pressure, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Intraocular Pressure
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2016to Apr 2019
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing robotic surgeries in steep trendelenburg position
Who may be able to join
- American Society of Anaesthesiologists (ASA) status 1-3
- without any ophthalmic complains or interventions
Who cannot join
- lasix given during preoperative or intraoperative period
- cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG)
- pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded
Trial locations and contacts
1 site in 1 country.
India1 site
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, National Capital Territory of Delhi, 110085
About this study
This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.
Read the detailed description
Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries.
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular Pressure, Trendelenburg position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| robotic surgery | all those patients aged 40 - 60 years undergoing robotic surgeries, who does not have any ophthalmic complains. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
change in pressure with the position during surgery
Measured: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018
- Study completionApr 2019
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nitesh Goel, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Nitesh Goel, MBBS,DA, DNB, Principal investigator, Rajiv Gandhi Cancer Institute & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646033
- Sponsor's protocol ID
- RajivGCIRC
- Status last verified
- Mar 2020
- First submitted
- 4 Jan 2016
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
- ClinicalTrials.gov ID
- NCT02646033
- Acronym / sponsor ID
- RajivGCIRC
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular Pressure, Trendelenburg position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 5 Jan 2016 (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.
This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.
Detailed description
Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| robotic surgery | – | –all those patients aged 40 - 60 years undergoing robotic surgeries, who does not have any ophthalmic complains. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing robotic surgeries in steep trendelenburg position
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists (ASA) status 1-3
- without any ophthalmic complains or interventions
Key exclusion criteria (3 listed)
- lasix given during preoperative or intraoperative period
- cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG)
- pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded
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
Intraocular pressure
Time frame: 7-8 months
change in pressure with the position during surgery
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 17 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Recruiting
Glaucoma Screening to Enhance At-Risk Californians' Health
Glaucoma
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
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.
Nitesh Goel, MBBS,DA, DNB principal investigator
Rajiv Gandhi Cancer Institute & Research Centre
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 Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 2 inclusion and 3 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 17 Mar 2020. 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 India. 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?
Intraocular pressure (time frame: 7-8 months). 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 17 Mar 2020.