Retinal Detachment
Conditions
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.
Interventions
DEVICEGlasScope Surgical Microscope
3D visualization of the poterior chamber for silicon oil removal
Sponsors
Elbit Systems LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Outcome results
None listed