Intraocular PressureNCT02697825
Intraocular Pressure Versus Optic Nerve Sheath Diameter
A study testing Schiotz tonometer for Intraocular Pressure in people with Intraocular Pressure and Optic Nerve Sheath Diameter, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Optic Nerve Sheath Diameter
- What is being tested?
- Schiotz tonometer for Intraocular Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- robotic surgeries
- surgical duration upto 4 hours
- american society of anaesthesiologists 1 to 3
Who cannot join
- any history of opthalmic intervention
- patient suffering from glaucoma
- patients taking any diuretics for cardiac problems
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Nitesh Goel, MBBS,DA,DNB, 09717773292, drniteshgoel@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Pressure, Optic Nerve Sheath Diameter
- Being tested
- Schiotz tonometer for Intraocular Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schiotz tonometer for Intraocular PressureProcedure or surgery
Also called Ultrasound for Optic nerve sheath diameter
Both Values will be corelated
| Study group | Role | What they receive |
|---|---|---|
| changes in eye | Other | 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. Receives: Procedure: Schiotz tonometer for Intraocular Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nitesh Goel, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Nitesh Goel, MBBS,DA, DNB, Principal investigator, Rajiv Gandhi Cancer Institute & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697825
- Sponsor's protocol ID
- RajivGCIRC1
- Status last verified
- Feb 2016
- First submitted
- 20 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: It will be decide only after the completion of study
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intraocular Pressure and Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT02697825
- Acronym / sponsor ID
- RajivGCIRC1
- Conditions
- Intraocular Pressure, Optic Nerve Sheath Diameter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| changes in eye | Other | Procedure: Schiotz tonometer for Intraocular PressureChanges in both intraocular pressure and optic nerve sheath diameter will be correlated in robotic surgeries to find out any statistical relation existing between two. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- robotic surgeries
- surgical duration upto 4 hours
- american society of anaesthesiologists 1 to 3
Key exclusion criteria (3 listed)
- any history of opthalmic intervention
- patient suffering from glaucoma
- patients taking any diuretics for cardiac problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schiotz tonometer for Intraocular PressureAlso: Ultrasound for Optic nerve sheath diameterBoth Values will be corelated | Procedure or surgery | changes in eye |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Individual participant dataSharing planned: Undecided. It will be decide only after the completion of study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitesh Goel, MBBS,DA, DNB principal investigator
Rajiv Gandhi Cancer Institute & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schiotz tonometer for Intraocular Pressure in people with Intraocular Pressure and Optic Nerve Sheath Diameter, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitesh Goel, MBBS,DA,DNB (01147022222 ext. 2323, drniteshgoel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between rise of intraocular pressure and optic nerve sheath diameter (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016; AzTrials last refreshed its copy on 26 Oct 2026.