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

Study Overview
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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.

Conditions
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Retinal Detachment

Intervention / Treatment
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* Device: GlasScope Surgical Microscope


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Field of view of GlasScope surgical microscope |  | Up to 3 days after surgery | 
| Depth of field of GlasScope surgical microscope |  | 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. | Up to 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 7 days after surgery |