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

Sponsor

Elbit Systems LTD (Industry)

Overall Status

Completed

CT.gov ID

NCT02715388

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	Device: GlasScope Surgical Microscope	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silicon oil removal 3D visualization	Device: GlasScope Surgical Microscope 3D visualization of the poterior chamber for silicon oil removal

Arm

Intervention/Treatment

Experimental: Silicon oil removal 3D visualization

Device: GlasScope Surgical Microscope

3D visualization of the poterior chamber for silicon oil removal

Outcome Measures

Primary Outcome Measures

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 [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sourasky Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

Elbit Systems LTD

Investigators

Principal Investigator: Adiel Barak, Prof, Head of Retina Department, Sourasky Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elbit Systems LTD

ClinicalTrials.gov Identifier:

NCT02715388

Other Study ID Numbers:

0389-15-TLV

First Posted:

Mar 22, 2016

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Retinal Detachment

Study Results

No Results Posted as of Apr 28, 2022