Corneal AstigmatismNCT05075746
Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
An observational study of Corneal Astigmatism, run by Bausch & Lomb Incorporated at 3 sites in Canada.
Trial summary
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Astigmatism
- What is being tested?
- enVista Toric and enVista non-Toric (spherical)
- Type of treatment
- Medical device
- How many people
- 302 participants
- Where
- 3 sitesCanada
- Study dates
- 8 Mar 2022to 3 Jan 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL in patients with pre-op corneal astigmatism <1.0D. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.
Who may be able to join
- Males and Females subjects age 18 or older on the date of surgery
- Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye
- Data available at least 4 weeks after IOL implantation
- Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator)
- Study eyes were implanted with the 0.9D toric lens
- Control eyes were not implanted with the 0.9D toric lens and implanted with a spherical (non-toric) equivalent instead
Who cannot join
- History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.)
- BCDVA of 20/25 or worse for the treated eye(s) after the surgery
- Excessive IOL rotation > 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Bausch Site 01
Calgary, Alberta, T2N 1N4
Bausch Site 03
Langley, British Columbia, V2Y 1N4
Bausch Site 02
Toronto, Ontario, M2P 2B7
About this study
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.
Read the detailed description
The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.
This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.
- Conditions
- Corneal Astigmatism
- Being tested
- enVista Toric, enVista non-Toric (spherical)
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enVista ToricDevice
enVista Toric IOL
enVista non-Toric (spherical)Device
enVista non-Toric (spherical) IOL
| Study group | Role | What they receive |
|---|---|---|
| enVista Toric 0.9D intra ocular lens | Not described Receives: Device: enVista Toric | |
| enVista non-Toric (spherical) intra ocular lens | Not described Receives: Device: enVista non-Toric (spherical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reduction in Cylindrical Power of the Eye
Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane).
Measured: 4 weeks after IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start8 Mar 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal AstigmatismStudies 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
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075746
- Sponsor's protocol ID
- BHC-RCR-001
- Status last verified
- Sep 2023
- First submitted
- 30 Sep 2021
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review of enVista Toric 0.9D Intraocular Lenses
- ClinicalTrials.gov ID
- NCT05075746
- Acronym / sponsor ID
- BHC-RCR-001
- Conditions
- Corneal Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the performance of the enVista Toric 0.9D vs non-Toric IOL.
Detailed description
The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.
This is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after IOL implantation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enVista Toric 0.9D intra ocular lens | – | Device: enVista Toric |
| enVista non-Toric (spherical) intra ocular lens | – | Device: enVista non-Toric (spherical) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The performance of the enVista Toric IOLs will be compared with that of enVista non-Toric (spherical) IOL in patients with pre-op corneal astigmatism <1.0D. At least 384 eyes (n= 192 per lens type) from 3-4 Canadian centers will be investigated.
Key inclusion criteria (6 listed)
- Males and Females subjects age 18 or older on the date of surgery
- Implant of enVista Toric IOL and/or enVista non-Toric (spherical) IOL in at least one eye
- Data available at least 4 weeks after IOL implantation
- Eyes must qualify for the 0.9D toric lens based on the Barrett Toric Calculator (flipped axis must be less than 0.2D) (https://ascrs.org/tools/barrett-toric-calculator)
Key exclusion criteria (3 listed)
- History of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.)
- BCDVA of 20/25 or worse for the treated eye(s) after the surgery
- Excessive IOL rotation > 10 degrees (Toric IOLs only) for the treated eye(s) after the surgery
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 |
|---|---|---|
| enVista ToricenVista Toric IOL | Device | enVista Toric 0.9D intra ocular lens |
| enVista non-Toric (spherical)enVista non-Toric (spherical) IOL | Device | enVista non-Toric (spherical) intra ocular lens |
Primary outcome
Mean Reduction in Cylindrical Power of the Eye
Time frame: 4 weeks after IOL implantation
Reduction in the cylindrical power of the eye is defined as the difference between the magnitudes of the preoperative keratometric cylinder and the residual refractive cylinder (referenced to the corneal plane).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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
Bausch Health Americas, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Astigmatism, run by Bausch & Lomb Incorporated at 3 sites in Canada.
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 6 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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Reduction in Cylindrical Power of the Eye (time frame: 4 weeks after IOL implantation). 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 27 Mar 2024.