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Completed

NCT Number: NCT02715388

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

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GlasScope Surgical Microscope

Device

3D visualization of the poterior chamber for silicon oil removal

Primary outcomes

  1. Field of view of GlasScope surgical microscope

    Time frame: Up to 3 days after surgery

  2. Depth of field of GlasScope surgical microscope

    Time frame: Up to 3 days after surgery

  3. 3D perception of GlasScope surgical microscope

    Time frame: 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 outcomes

  1. Surgeon fatigue and neck strain (questionnaire)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Elbit Systems LTD

Industry

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2016
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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