Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes

April 27, 2022 updated by: Elbit Systems LTD
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18.
  • Pseudophakia patients with silicone oil in the vitreous cavity.
  • Silicone oil density of 1500 centistoke or 5500 CS.
  • Good corrected visual acuity (> 6/10) in the second eye.
  • Lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).

Exclusion Criteria:

  • Additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
  • The presence of heavy silicone oil (OXANE) in the vitreous cavity.
  • Posterior segment pathology in the second eye.
  • Special populations (children under the age of 18, pregnant women)

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silicon oil removal 3D visualization
Device: GlasScope Surgical Microscope
3D visualization of the poterior chamber for silicon oil removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Field of view of GlasScope surgical microscope
Time Frame: Up to 3 days after surgery
Up to 3 days after surgery
Depth of field of GlasScope surgical microscope
Time Frame: Up to 3 days after surgery
Up to 3 days after surgery
3D perception of GlasScope surgical microscope
Time Frame: Up to 3 days after surgery
3D perception of GlasScope surgical microscope is assessed by the surgeon ability to perform surgical gentle procedures using the surgical tools on the eye tissues - both inner and posterior parts of the eye.
Up to 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon fatigue and neck strain (questionnaire)
Time Frame: Up to 7 days after surgery
Questioning the surgeons after surgery on the pain and stress during the use of Glasscope causing decreased performance/lack of concentration/fatigue, the complexity on keeping the eye-piece image in the surgeon sight, how the instrument prevents the surgeon situation awareness in the operating room, the stress and fatigue on the surgeon eyes for long duration of observation in the image
Up to 7 days after surgery

Collaborators and Investigators

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

Sponsor

Elbit Systems LTD

Investigators

  • Principal Investigator: Adiel Barak, Prof, Head of Retina Department, Sourasky 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

January 1, 2016

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0389-15-TLV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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