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

Not Applicable

Terminated

• Conditions: Gastrointestinal Cancer; Malignant Female Reproductive System Neoplasm; Urological Cancer
• Interventions: Device: IOP by tonometer; Device: Anterior chamber depth measurement by ultrasound

• Registration Number: NCT02818530
• Lead Sponsor: Tata Memorial Centre

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.

Study Timeline

• Study First Submitted: 2016-06-18
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Study Start: 2017-06-21
• Status Verified: 2018-05
• Primary Completion: 2018-05-07
• Study Completion: 2018-05-07
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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,

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IOP by tomoneter and ultrasound	IOP by tonometer	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.
IOP by tomoneter and ultrasound	Anterior chamber depth measurement by 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.

Primary Outcome Measures

Name	Time	Method
Changes in intraocular pressure measured by tonometer	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.	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sohan Lal solanki; 🇮🇳 Mumbai, Maharashtra, India