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

NCT ID: NCT02818530

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2018-05-07

Brief Summary

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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

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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.

Conditions

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Urological Cancer Gastrointestinal Cancer Malignant Female Reproductive System Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IOP by tonometer

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tata Memorial Centre

OTHER

Sponsor Role lead

Responsible Party

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Sohan Lal Solanki

Assistant Professor, Department of Anesthesiology, Critical Care and Pain

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sohan L Solanki, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Centre

Locations

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Sohan Lal solanki

Mumbai, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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PN 1690

Identifier Type: -

Identifier Source: org_study_id

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