Performance and Safety of Routine Cataract Surgery With Visiol

NCT04866706 | Completed

• 1 other identifier: SVS18-CT-1901
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Following Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Corneal endothelial cells density in percent

  The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%)

  Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90

Other Outcomes (26)

• Corneal endothelial cells area

  Change from pre-surgery Corneal endothelial cells area at Day 1, Day 7, Day 30, Day 90

• Corneal endothelial cells density

  Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90

• Corneal endothelial cells regularity

  Change from pre-surgery Corneal endothelial cells regularity at Day 1, Day 7, Day 30, Day 90

Interventions

Visiol DEVICE

VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery.

Also known as: Sodium hyaluronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Over 18 years cataract patients whom investigator routine considered to treat by surgery with Visiol before recruit to study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TRB Chemedica: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 30, 2021
• Study Start: January 27, 2022
• Primary Completion: December 9, 2022
• Study Completion: October 27, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-04

Locations

TH (1)