Intraocular Pressure Versus Optic Nerve Sheath Diameter

Intraocular Pressure Clinical Trial

Official title:

Correlation Between Intraocular Pressure and Optic Nerve Sheath Diameter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02697825
• Other study ID #: RajivGCIRC1
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2016
• Last updated: February 26, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: Nitesh Goel, MBBS,DA,DNB
• Phone: 01147022222
• Email: drniteshgoel[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intraocular Pressure
• Optic Nerve Sheath Diameter

Intervention

Procedure:
• Schiotz tonometer for Intraocular Pressure
Both Values will be corelated

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute & Research Centre	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between rise of intraocular pressure and optic nerve sheath diameter	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	No