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

Elbit Systems LTD72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinal Detachment

Interventions

GlasScope Surgical MicroscopeDEVICE

3D visualization of the poterior chamber for silicon oil removal

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Sourasky Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

Field of view of GlasScope surgical microscope

Time frame: Up to 3 days after surgery

Depth of field of GlasScope surgical microscope

Time frame: Up to 3 days after surgery

3D perception of GlasScope surgical microscope

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.

Time frame: Up to 3 days after surgery

Secondary Outcomes

Surgeon fatigue and neck strain (questionnaire)

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

Time frame: Up to 7 days after surgery

Data from ClinicalTrials.gov

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