Performance and Safety of Routine Cataract Surgery With Visiol

TRB Chemedica

Status: Completed

Conditions: Following Cataract Surgery

Treatments: Device: Visiol

Study type: Observational

Funder types: Industry

Identifiers

NCT04866706

SVS18-CT-1901

Details and patient eligibility

About

In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 years and older;
• Candidate for cataract surgery via phacoemulsification;
• Ophthalmic surgeon's recommendation to use VISIOL prior to recruitment;
• Eligible for the use of VISIOL as indicated in the instructions for use;
• Written informed consent.

Exclusion criteria

• Known allergy or hypersensitivity to any of VISIOL components;
• Known pregnancy or breast feeding;
• Participation in any other clinical research study within the last 90 days;
• Patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection);
• Incapacity to understand the informed consent and/or to comply with the Clinical Investigation Plan (CIP), per investigator's appreciation.