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Clinical Trials/NCT02715388
NCT02715388CompletedNot Applicable

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

Elbit Systems LTD1 site in 1 country72 target enrollmentStarted: January 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
Depth of field of GlasScope surgical microscope
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients older than
  • •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)

Arms & Interventions

Silicon oil removal 3D visualization

Experimental

Intervention: GlasScope Surgical Microscope (Device)

Outcomes

Primary Outcomes

Depth of field of GlasScope surgical microscope

Time Frame: Up to 3 days after surgery

Field of view of GlasScope surgical microscope

Time Frame: 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.

Secondary Outcomes

  • Surgeon fatigue and neck strain (questionnaire)(Up to 7 days after surgery)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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