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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715388
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Elbit Systems LTD

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Device: GlasScope Surgical Microscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Field of view of GlasScope surgical microscope [ Time Frame: Up to 3 days after surgery ]
  2. Depth of field of GlasScope surgical microscope [ Time Frame: Up to 3 days after surgery ]
  3. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715388


Contacts
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Contact: Ron Schneider, Msc 972-4-8318899 ron.schneider@elbitsystems.com

Locations
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Israel
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Adiel Barak, MD    972-3-6973408    adielb@tlvmc.gov.il   
Sponsors and Collaborators
Elbit Systems LTD
Investigators
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Principal Investigator: Adiel Barak, Prof Head of Retina Department, Sourasky Medical Center
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Responsible Party: Elbit Systems LTD
ClinicalTrials.gov Identifier: NCT02715388    
Other Study ID Numbers: 0389-15-TLV
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Diseases
Eye Diseases