CataractNCT02394379
Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL
An observational study of Cataract, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- Trulign™ Toric IOL
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2015to 5 Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be chosen from 30-50 clinical sites in the US. All subjects who meet Eligibility Criteria (below) will be consecutively offered enrollment until the site meets the maximum number of enrollees.
Who may be able to join
- Subjects who are able and willing to comply with the follow-up schedule
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction
- Subjects must require a lens power from 4 to 33 D
- Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source
Who cannot join
- Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery
- Subjects with associated ocular conditions which could affect the stability of the IOL
- Subjects with clinically significant irregular corneal astigmatism in the study eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Bausch & Lomb Incorporated
Rochester, New York, 14609
About this study
Official title: A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL)
To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.
Read the detailed description
The objective of this post approval safety study is to evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to three years post implantation.
- Conditions
- Cataract
- Being tested
- Trulign™ Toric IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trulign™ Toric IOLDevice
Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens
| Study group | Role | What they receive |
|---|---|---|
| Trulign™ Toric IOL | Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens Receives: Device: Trulign™ Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant IOL vaulting
IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start19 Mar 2015
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Valeant Pharmaceuticals NA / Bausch & Lomb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394379
- Sponsor's protocol ID
- 858
- Status last verified
- Nov 2019
- First submitted
- 9 Mar 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT02394379
- Acronym / sponsor ID
- 858
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 20 Mar 2015 (estimated)
- 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.
To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery.
Detailed description
The objective of this post approval safety study is to evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to three years post implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trulign™ Toric IOL | – | Device: Trulign™ Toric IOLTrulign™ Toric Posterior Chamber IOL is a modified plate haptic lens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be chosen from 30-50 clinical sites in the US. All subjects who meet Eligibility Criteria (below) will be consecutively offered enrollment until the site meets the maximum number of enrollees.
Key inclusion criteria (4 listed)
- Subjects who are able and willing to comply with the follow-up schedule
- Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction
- Subjects must require a lens power from 4 to 33 D
- Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than 20/40, with or without a glare source
Key exclusion criteria (3 listed)
- Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery
- Subjects with associated ocular conditions which could affect the stability of the IOL
- Subjects with clinically significant irregular corneal astigmatism in the study eye
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 |
|---|---|---|
| Trulign™ Toric IOLTrulign™ Toric Posterior Chamber IOL is a modified plate haptic lens | Device | Trulign™ Toric IOL |
Primary outcome
Incidence of clinically significant IOL vaulting
Time frame: Up to 3 years
IOL vaulting is position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting. The proportion of study eyes experiencing vaulting will be estimated by Kaplan-Meier method.
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 13 Nov 2019.
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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.
Anya Loncaric study director
Valeant Pharmaceuticals NA / Bausch & Lomb
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 Cataract, run by Bausch & Lomb Incorporated at 1 site in United States.
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 4 inclusion and 3 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 13 Nov 2019. 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 United States. 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?
Incidence of clinically significant IOL vaulting (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.