Following Cataract SurgeryNCT04866706
Performance and Safety of Routine Cataract Surgery With Visiol
An observational study of Following Cataract Surgery, run by TRB Chemedica at 1 site in Thailand.
Trial summary
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Following Cataract Surgery
- What is being tested?
- Visiol
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 27 Jan 2022to 27 Oct 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 years cataract patients whom investigator routine considered to treat by surgery with Visiol before recruit to study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed
- Conditions
- Following Cataract Surgery
- Being tested
- Visiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisiolDevice
Also called Sodium hyaluronate
VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial cells density in percent
The variation of corneal endothelial cells density (cells/mm2) as compared to baseline (pre-surgery) will be calculated (%)
Measured: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start27 Jan 2022
- Primary completion9 Dec 2022
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Following Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- TRB Chemedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866706
- Sponsor's protocol ID
- SVS18-CT-1901
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rojananuangnit K, Somkijrungroj T, Hongyok T, Thatsnarong D, Panyayingyong N, Collaud Basset S. Real-World Performance and Safety of VISIOL in Modern Routine Cataract Surgery. Ophthalmol Ther. 2026 Apr;15(4):1389-1405. doi: 10.1007/s40123-026-01345-w. Epub 2026 Mar 5.
PubMed 41787207
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety of Routine Cataract Surgery With Visiol
- ClinicalTrials.gov ID
- NCT04866706
- Acronym / sponsor ID
- SVS18-CT-1901
- Conditions
- Following Cataract Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TRB ChemedicaIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 years cataract patients whom investigator routine considered to treat by surgery with Visiol before recruit to study
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisiolAlso: Sodium hyaluronateVISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery. | Device | – |
Primary outcome
Corneal endothelial cells density in percent
Time frame: 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 (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 41787207Rojananuangnit K, Somkijrungroj T, Hongyok T, Thatsnarong D, Panyayingyong N, Collaud Basset S. Real-World Performance and Safety of VISIOL in Modern Routine Cataract Surgery. Ophthalmol Ther. 2026 Apr;15(4):1389-1405. doi: 10.1007/s40123-026-01345-w. Epub 2026 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Following Cataract Surgery, run by TRB Chemedica at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal endothelial cells density in percent (time frame: Change from pre-surgery Corneal endothelial cells density at Day 1, Day 7, Day 30, Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.