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

E

Elbit Systems

Status

Completed

Conditions

Retinal Detachment

Treatments

Device: GlasScope Surgical Microscope

Study type

Interventional

Funder types

Industry

Identifiers

NCT02715388
0389-15-TLV

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

72 participants in 1 patient group

Silicon oil removal 3D visualization
Experimental group
Treatment:
Device: GlasScope Surgical Microscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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