Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedApril 28, 2022
April 1, 2022
6 years
March 15, 2016
April 27, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Surgeon fatigue and neck strain (questionnaire)
Up to 7 days after surgery
Study Arms (1)
Silicon oil removal 3D visualization
EXPERIMENTALInterventions
3D visualization of the poterior chamber for silicon oil removal
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sourasky Medical Center
Tel Aviv, 64239, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adiel Barak, Prof
Head of Retina Department, Sourasky Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2016
First Posted
March 22, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share