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

NCT ID: NCT03097705

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraocular Pressure Retinal Nerve Fiber Bundle Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IOP and OCT RNFL measurements

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

Group Type OTHER

OCT (Optical coherence tomography)

Intervention Type DIAGNOSTIC_TEST

RNFL AND IOP MEASUREMNTS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCT (Optical coherence tomography)

RNFL AND IOP MEASUREMNTS

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CARE (ICARE FINLAND Oy)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* SUBJECT WITH EYES DISEASE
* PREGNANCY DURING THE STUDY PERIOD
Minimum Eligible Age

40 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Orna Geyer

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMC-17-0026-CTIL

Identifier Type: -

Identifier Source: org_study_id