Back to resultsProof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
Primary Purpose
Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
GlasScope Surgical Microscope
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment
Eligibility Criteria
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)
Sites / Locations
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Silicon oil removal 3D visualization
Arm Description
Outcomes
Primary Outcome Measures
Field of view of GlasScope surgical microscope
Depth of field of GlasScope surgical microscope
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02715388
Brief Title
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elbit Systems LTD
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silicon oil removal 3D visualization
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
GlasScope Surgical Microscope
Intervention Description
3D visualization of the poterior chamber for silicon oil removal
Primary Outcome Measure Information:
Title
Field of view of GlasScope surgical microscope
Time Frame
Up to 3 days after surgery
Title
Depth of field of GlasScope surgical microscope
Time Frame
Up to 3 days after surgery
Title
3D perception of GlasScope surgical microscope
Description
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 Outcome Measure Information:
Title
Surgeon fatigue and neck strain (questionnaire)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adiel Barak, Prof
Organizational Affiliation
Head of Retina Department, Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
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