search
Back to results

Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound

Primary Purpose

Urological Cancer, Gastrointestinal Cancer, Malignant Female Reproductive System Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
IOP by tonometer
Anterior chamber depth measurement by ultrasound
Sponsored by
Tata Memorial Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urological Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA class I-III
  2. Urological cancer patients under going robotic assisted surgeries.
  3. Gastrointestinal cancer patients under going robotic assisted surgeries,
  4. Gynecological cancer patients under going robotic assisted surgeries,

Exclusion Criteria:

  1. ASA class IV and above
  2. Patients with a history of glaucoma.
  3. Patients with corneal disease, retinal vascular disease.

Sites / Locations

  • Sohan Lal solanki

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IOP by tomoneter and ultrasound

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Time dependent changes in IOP during prolonged steep Trendelenberg position.
Time dependent changes in anterior chamber depth during prolonged trendelenberg position.

Full Information

First Posted
June 18, 2016
Last Updated
May 8, 2018
Sponsor
Tata Memorial Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT02818530
Brief Title
Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound
Official Title
Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound in Steep Trendelenberg Position During Robotic Assisted Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Two patients developed corneal laceration and hence study re-reviewed by IEC and decided to terminate the study prematurely
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
May 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urological Cancer, Gastrointestinal Cancer, Malignant Female Reproductive System Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOP by tomoneter and ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IOP by tonometer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Anterior chamber depth measurement by ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in intraocular pressure measured by tonometer
Description
Intra operative recordings of IOP will be after induction and thereafter will be measured every 2 hours and at the end of surgery.
Time Frame
Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Title
Changes in anterior chamber depth measured by ultrasound.
Description
Intra operative recordings of anterior chamber depth will be measured after induction of anaesthesia, every 2 hours intraoperatively and at end of surgery.
Time Frame
Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, Exclusion Criteria: ASA class IV and above Patients with a history of glaucoma. Patients with corneal disease, retinal vascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohan L Solanki, MD
Organizational Affiliation
Tata Memorial Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohan Lal solanki
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400088
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound

We'll reach out to this number within 24 hrs