NCT03097705

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

March 8, 2017

Last Update Submit

March 26, 2017

Conditions

Intraocular PressureRetinal Nerve Fiber Bundle Deficiency

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

IOP and OCT RNFL measurements

OTHER

all subjects will undergo ophthalmological exams including IOP and RNFL OCT measurements

Diagnostic Test: OCT (Optical coherence tomography)

Interventions

OCT (Optical coherence tomography)DIAGNOSTIC_TEST

RNFL AND IOP MEASUREMNTS

Also known as: CARE (ICARE FINLAND Oy)
IOP and OCT RNFL measurements

Eligibility Criteria

Age40 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • SUBJECT WITH EYES DISEASE
  • PREGNANCY DURING THE STUDY PERIOD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 31, 2017

Study Start

April 20, 2017

Primary Completion

September 12, 2017

Study Completion

March 12, 2018

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share