Urological CancerNCT02818530
Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound
A study testing IOP by tonometer and Anterior chamber depth measurement by ultrasound in people with Urological Cancer and Gastrointestinal Cancer, run by Tata Memorial Centre at 1 site in India.
Trial summary
Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urological Cancer, Gastrointestinal Cancer, Malignant Female Reproductive System Neoplasm
- What is being tested?
- IOP by tonometer and Anterior chamber depth measurement by ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jun 2017to 7 May 2018
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-III
- Urological cancer patients under going robotic assisted surgeries.
- Gastrointestinal cancer patients under going robotic assisted surgeries,
- Gynecological cancer patients under going robotic assisted surgeries,
Who cannot join
- ASA class IV and above
- Patients with a history of glaucoma.
- Patients with corneal disease, retinal vascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound in Steep Trendelenberg Position During Robotic Assisted Surgery
Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone.
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes.
Read the detailed description
Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone. During the robotic surgery there are two theories explaining the increase of IOP, first, gravitational forces increase central venous pressure which in turn affect orbital venous pressure and increase IOP. Second, intraperitoneal carbon dioxide causes increased choroidal blood volume which may result in IOP increase. One study reported that low end tidal carbon dioxide was a significant predictor of the IOP increase. Continuous absorption of carbon dioxide from peritoneum and increased pressure on diaphragm results in lower delivered tidal volumes and subsequently increased arterial carbon dioxide levels leading to increased choroidal blood flow and increased IOP.
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes. It can also be used for serial examination and follow-up of treatment success. They also mentioned that, it is necessary to conduct a prospective study with a larger sample size, to evaluate if there is agreement between measurements using a tonometer and measurements of the ACD using ultrasound. In addition, it is essential to determine the cut off normal ACD for evaluation of IOP.
- Being tested
- IOP by tonometer, Anterior chamber depth measurement by ultrasound
- Medical subject headings
- Urologic Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP by tonometerDevice
Electronic tonometer will be used as gold standard for intraocular pressure measurement in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery.
Anterior chamber depth measurement by ultrasoundDevice
Anterior chamber depth will be measured by ultrasound in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| IOP by tomoneter and ultrasound | Experimental | Intraocular pressure will be measured by electronic tomometer (tonopen) at different point of time after induction of anaesthesia in patients undergoing robotic assisted surgery under steep Trendelenberg position. Anterior chamber depth will be measured by ultrasound at the same time intervals. Receives: Device: IOP by tonometer; Device: Anterior chamber depth measurement by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intraocular pressure measured by tonometer
Intra operative recordings of IOP will be after induction and thereafter will be measured every 2 hours and at the end of surgery.
Measured: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Changes in anterior chamber depth measured by ultrasound.
Intra operative recordings of anterior chamber depth will be measured after induction of anaesthesia, every 2 hours intraoperatively and at end of surgery.
Measured: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Secondary outcomes (2)
Time dependent changes in IOP during prolonged steep Trendelenberg position.
Measured: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Time dependent changes in anterior chamber depth during prolonged trendelenberg position.
Measured: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start21 Jun 2017
- Primary completion7 May 2018
- Study completion7 May 2018
Why it stopped: Two patients developed corneal laceration and hence study re-reviewed by IEC and decided to terminate the study prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological CancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohan Lal Solanki, Tata Memorial Centre
- Investigators
- Sohan L Solanki, MD, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818530
- Sponsor's protocol ID
- PN 1690
- Status last verified
- May 2018
- First submitted
- 18 Jun 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound in Steep Trendelenberg Position During Robotic Assisted Surgery
- ClinicalTrials.gov ID
- NCT02818530
- Acronym / sponsor ID
- PN 1690
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Two patients developed corneal laceration and hence study re-reviewed by IEC and decided to terminate the study prematurely
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 29 Jun 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.
Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone.
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes.
Detailed description
Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone. During the robotic surgery there are two theories explaining the increase of IOP, first, gravitational forces increase central venous pressure which in turn affect orbital venous pressure and increase IOP. Second, intraperitoneal carbon dioxide causes increased choroidal blood volume which may result in IOP increase. One study reported that low end tidal carbon dioxide was a significant predictor of the IOP increase. Continuous absorption of carbon dioxide from peritoneum and increased pressure on diaphragm results in lower delivered tidal volumes and subsequently increased arterial carbon dioxide levels leading to increased choroidal blood flow and increased IOP.
Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes. It can also be used for serial examination and follow-up of treatment success. They also mentioned that, it is necessary to conduct a prospective study with a larger sample size, to evaluate if there is agreement between measurements using a tonometer and measurements of the ACD using ultrasound. In addition, it is essential to determine the cut off normal ACD for evaluation of IOP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOP by tomoneter and ultrasound | Experimental | Device: IOP by tonometer, Device: Anterior chamber depth measurement by ultrasoundIntraocular pressure will be measured by electronic tomometer (tonopen) at different point of time after induction of anaesthesia in patients undergoing robotic assisted surgery under steep Trendelenberg position. Anterior chamber depth will be measured by ultrasound at the same time intervals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA class I-III
- Urological cancer patients under going robotic assisted surgeries.
- Gastrointestinal cancer patients under going robotic assisted surgeries,
- Gynecological cancer patients under going robotic assisted surgeries,
Key exclusion criteria (3 listed)
- ASA class IV and above
- Patients with a history of glaucoma.
- Patients with corneal disease, retinal vascular disease.
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 |
|---|---|---|
| IOP by tonometerElectronic tonometer will be used as gold standard for intraocular pressure measurement in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery. | Device | IOP by tomoneter and ultrasound |
| Anterior chamber depth measurement by ultrasoundAnterior chamber depth will be measured by ultrasound in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery. | Device | IOP by tomoneter and ultrasound |
Primary outcome
Changes in intraocular pressure measured by tonometer
Time frame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Intra operative recordings of IOP will be after induction and thereafter will be measured every 2 hours and at the end of surgery.
Changes in anterior chamber depth measured by ultrasound.
Time frame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Intra operative recordings of anterior chamber depth will be measured after induction of anaesthesia, every 2 hours intraoperatively and at end of surgery.
2 secondary outcomes
Time dependent changes in IOP during prolonged steep Trendelenberg position.
Time frame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Time dependent changes in anterior chamber depth during prolonged trendelenberg position.
Time frame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Results and safety
The study was stopped early (reason given: Two patients developed corneal laceration and hence study re-reviewed by IEC and decided to terminate the study prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sohan L Solanki, MD principal investigator
Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOP by tonometer and Anterior chamber depth measurement by ultrasound in people with Urological Cancer and Gastrointestinal Cancer, run by Tata Memorial Centre 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 4 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: stopped early, as of the sponsor's last update on 14 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 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 was stopped early (reason given: Two patients developed corneal laceration and hence study re-reviewed by IEC and decided to terminate the study prematurely). 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?
Changes in intraocular pressure measured by tonometer (time frame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery). The study lists 2 primary outcomes in all. 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 14 May 2018.