EVA Nexus Vitrectomy Device Field Observation Study

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Vitreous Disorder; Retina Disorder

Treatments: Device: Eva Nexus

Study type: Observational

Funder types: Other

Identifiers

NCT05229094

64913

Details and patient eligibility

About

determine the safety and effectiveness of the device.

Full description

To perform a field observation study using the newly developed EVA Nexus vitrectomy device.

Patients that are scheduled for intra-ocular surgery regardless of the indication:

• Vitrectomy surgery
• Cataract surgery
• Vitrectomy combined with cataract surgery

Enrollment: 250 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that are scheduled for intra-ocular surgery regardless of the indication:
• Vitrectomy surgery
• Cataract surgery
• Vitrectomy combined with cataract surgery
• In case of (combined) vitrectomy: primary or repeat vitrectomy
• General or retrobulbar anesthesia, the latter can be combined with sedation
• Patients aged ≥ 18 years

Exclusion criteria

• Patients aged < 18 years

Trial design