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

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.

Study Overview

• Status: Terminated
• Conditions: Gastrointestinal Cancer; Malignant Female Reproductive System Neoplasm; Urological Cancer
• Intervention / Treatment: Device: IOP by tonometer; Device: Anterior chamber depth measurement by ultrasound

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400088
      • Sohan Lal solanki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: IOP by tomoneter and ultrasound; 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.

Device: IOP by tonometer; 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.; Device: Anterior chamber depth measurement by ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Time dependent changes in IOP during prolonged steep Trendelenberg position.	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.	Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery

Collaborators and Investigators

• Sponsor: Tata Memorial Centre
• Investigators: Principal Investigator: Sohan L Solanki, MD, Tata Memorial Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2017
• Primary Completion (ACTUAL): May 7, 2018
• Study Completion (ACTUAL): May 7, 2018

Study Registration Dates

• First Submitted: June 18, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (ESTIMATE): June 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Genital Neoplasms, Female; Urologic Neoplasms
• Other Study ID Numbers: PN 1690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No