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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Page 1 of 1 (1 locations)

1

Rajavithi Hospital

Bangkok, Thailand, 10400