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

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Device: GlasScope Surgical Microscope

• Registration Number: NCT02715388
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-22
• Primary Completion: 2022-01
• Study Completion: 2022-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silicon oil removal 3D visualization	GlasScope Surgical Microscope	-

Primary Outcome Measures

Name	Time	Method
Depth of field of GlasScope surgical microscope	Up to 3 days after surgery
Field of view of GlasScope surgical microscope	Up to 3 days after surgery
3D perception of GlasScope surgical microscope	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

Name	Time	Method
Surgeon fatigue and neck strain (questionnaire)	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

Trial Locations

Locations (1)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel