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

NCT ID: NCT02715388

Last Updated: 2022-04-28

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retinal Detachment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Silicon oil removal 3D visualization

Group Type EXPERIMENTAL

GlasScope Surgical Microscope

Intervention Type DEVICE

3D visualization of the poterior chamber for silicon oil removal

Interventions

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GlasScope Surgical Microscope

3D visualization of the poterior chamber for silicon oil removal

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elbit Systems LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adiel Barak, Prof

Role: PRINCIPAL_INVESTIGATOR

Head of Retina Department, Sourasky Medical Center

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0389-15-TLV

Identifier Type: -

Identifier Source: org_study_id

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