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

Gastrointestinal Cancer Clinical Trial

Official title:

Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound in Steep Trendelenberg Position During Robotic Assisted Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02818530
• Other study ID #: PN 1690
• Status: Terminated
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: May 7, 2018

Study information

• Verified date: May 2018
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Urologic Neoplasms
• Urological Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Sohan Lal solanki	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time dependent changes in IOP during prolonged steep Trendelenberg position.		Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Secondary	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