Performance and Safety of Routine Cataract Surgery With Visiol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-27

Study Completion Date

2023-10-27

Brief Summary

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

Detailed Description

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Conditions

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Following Cataract Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Visiol

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

Intervention Type DEVICE

Other Intervention Names

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Sodium hyaluronate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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SVS18-CT-1901

Identifier Type: -

Identifier Source: org_study_id