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NCT03097705 Clinical Trial

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

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03097705
Other study ID # CMC-17-0026-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 8, 2017
Last updated March 26, 2017
Start date April 20, 2017
Est. completion date March 12, 2018

Study information
Verified date March 2017
Source Carmel Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date March 12, 2018
Est. primary completion date September 12, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• OCT (Optical coherence tomography)
RNFL AND IOP MEASUREMNTS

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Carmel Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Intra Ocular Pressure (IOP) 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
Primary Retinal Nerve Fiber Layer Thickness (RNFL) using OCT 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
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