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

Retinal Detachment Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715388
• Other study ID #: 0389-15-TLV
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2022

Study information

• Verified date: April 2022
• Source: Elbit Systems LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Device:
• GlasScope Surgical Microscope
3D visualization of the poterior chamber for silicon oil removal

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Elbit Systems LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Field of view of GlasScope surgical microscope		Up to 3 days after surgery
Primary	Depth of field of GlasScope surgical microscope		Up to 3 days after surgery
Primary	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	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