Zeiss RESIGHT Disposable Lenses Evaluation Study

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Vitreomacular Traction

Retinal Detachment

Macular Pucker

Macular Holes

Treatments

Device: ZEISS disposable

Study type

Interventional

Funder types

Other

Identifiers

NCT05860985

S67415

Details and patient eligibility

About

To evaluate the intra-operative efficacy of a new intra-operative viewing device.

Full description

This study is designed to obtain more information on the efficacy of the disposable RESIGHT lenses in routine vitrectomy surgery. This information can lead to adjustments to these surgical lenses to further fine tune a device which can be used by other surgeons.

Theoretically, both the improved lens design and better resistance to fogging should improve the visualization of the retina hence facilitate the surgery, increasing the surgical safety.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
Patients that are scheduled for primary vitrectomy surgery to treat retinal detachment or macular disease (pucker, macular hole, vitreomacular traction).
Both vitrectomy-only and combined phaco-vitrectomy surgeries
General or local anesthesia, or combination

Exclusion criteria

Patient who do not have sufficient command of the Dutch language to read and understand the informed consent form
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Repeat vitrectomy surgery