Status:
COMPLETED
Performance and Safety of Routine Cataract Surgery With Visiol
Lead Sponsor:
TRB Chemedica
Conditions:
Following Cataract Surgery
Eligibility:
All Genders
18+ years
Brief Summary
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04866706
Start Date
January 27 2022
End Date
October 27 2023
Last Update
November 22 2023
Active Locations (1)
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1
Rajavithi Hospital
Bangkok, Thailand, 10400