Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness

March 26, 2017 updated by: Orna Geyer, Carmel Medical Center

The Effect of Steep Trendelenburg Position Used During Laparoscopic Surgery on Intraocular Pressure During Surgery and on the Retinal Nerve Fiber Thickness After Surgery

The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES

Exclusion Criteria:

  • SUBJECT WITH EYES DISEASE
  • PREGNANCY DURING THE STUDY PERIOD

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: IOP and OCT RNFL measurements
all subjects will undergo ophthalmological exams including IOP and RNFL OCT measurements
Diagnostic test: OCT (Optical coherence tomography)
RNFL AND IOP MEASUREMNTS
Other Names:
  • CARE (ICARE FINLAND Oy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra Ocular Pressure (IOP)
Time Frame: Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery
IOP measurement will be taken before, during and after surgery using ICARE tonometer
Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery
Retinal Nerve Fiber Layer Thickness (RNFL) using OCT
Time Frame: Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery
RNFL measurement will be taken before and after surgery using spectralis OCT
Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery

Collaborators and Investigators

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

Sponsor

Carmel Medical Center

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 (Anticipated)

April 20, 2017

Primary Completion (Anticipated)

September 12, 2017

Study Completion (Anticipated)

March 12, 2018

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 26, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 26, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CMC-17-0026-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Intraocular Pressure

Clinical Trials on OCT (Optical coherence tomography)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe