Performance and Safety of Routine Cataract Surgery With Visiol

Completed

• Conditions: Following Cataract Surgery

• Registration Number: NCT04866706
• Lead Sponsor: TRB Chemedica

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-30
• Study Start: 2022-01-27
• Primary Completion: 2022-12-09
• Status Verified: 2023-04
• Study Completion: 2023-10-27
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal endothelial cells density in percent	Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90	The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%)

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand