Intraocular Pressure Versus Optic Nerve Sheath Diameter

February 26, 2016 updated by: Dr. Nitesh Goel, Rajiv Gandhi Cancer Institute & Research Center, India

Correlation Between Intraocular Pressure and Optic Nerve Sheath Diameter

This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath Diameter in steep trendelenburg position. Both observations will be done in same patient over the surgical duration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Steep trendelenburg position is required for various robotic surgical procedures like hysterectomy, radical prostatectomy etc. Both Intraocular Pressure and Optic Nerve Sheath Diameter are found to get increased while in this position.

Intraocular Pressure will be measured by schiotz tonometer over an hourly interval whereas Optic nerve sheath diameter will be measured with use of ultrasound using a probe of 7.5 Mega hertz. Both values will be measured in both the eyes and will be compared statistically to find any correlation which may exist between the two.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute & Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • robotic surgeries
  • surgical duration upto 4 hours
  • american society of anaesthesiologists 1 to 3

Exclusion Criteria:

  • any history of opthalmic intervention
  • patient suffering from glaucoma
  • patients taking any diuretics for cardiac problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: changes in eye
Changes in both intraocular pressure and optic nerve sheath diameter will be correlated in robotic surgeries to find out any statistical relation existing between two.
Procedure: Schiotz tonometer for Intraocular Pressure
Both Values will be corelated
Other Names:
  • Ultrasound for Optic nerve sheath diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between rise of intraocular pressure and optic nerve sheath diameter
Time Frame: 9 months
Intraocular pressure will be measured using schiotz tonometer whereas optic nerve sheath diameter will be assessed using ultrasound in same patient at same intervals. This will give us both the values of intraocular pressure and optic nerve sheath diameter at same time which as per previous studies increases and are statistically significant. After compilation of results it will be analyzed that whether both values increases in a correlated manner or not which will give us our results that whether increase of one value can tell the increase of other value.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

  • Principal Investigator: Nitesh Goel, MBBS,DA, DNB, Rajiv Gandhi Cancer Institute & Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

February 20, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RajivGCIRC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It will be decide only after the completion of study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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