IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Vitrectomy

Treatments: Device: IRIS

Study type: Interventional

Funder types: Other

Identifiers

NCT04409808

S62660

Details and patient eligibility

About

To perform a safety study on the prototype IRIS vitrectomy device.

Full description

to determine the safety and effectiveness of the device.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that are scheduled for vitrectomy surgery, regardless of the indication
• Both vitrectomy-only and combined phaco-vitrectomy surgeries
• Primary or repeat vitrectomy
• General or local anesthesia, or combination
• All ages
• Informed consent (from parents in patients <18 years old)

Exclusion criteria

• Unable to obtain informed consent from patient (or from parents in children)
• No post-operative 8 week visit is anticipated

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

IRIS vitrectomy device

Experimental group

Description:

all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device

Treatment:

Device: IRIS