CataractNCT05119127
Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
A study testing Alcon Vivity toric intra ocular lens in people with Cataract, run by Kevin Barber at 1 site in United States.
Trial summary
The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Alcon Vivity toric intra ocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 19 Aug 2021
- Phase
- Interventional
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects undergoing cataract extraction with intraocular lens implantation.
- Age: 45 years and older.
- Willing and able to comply with scheduled visits and other study procedures.
- Subjects who require an IOL power in the range of +15.0 D to +25.0 D.
- Subjects with regular corneal astigmatism that can be treated with T3-T5.
- Have good ocular health, with no pathology that compromises visual acuity (Outside of residual refractive error and cataract)
- Potential postoperative visual acuity of 0.2 logMAR/ETDRS (20/32 Snellen) or better in both eyes.
Who cannot join
- Glaucoma.
- Clinically significant corneal dystrophy.
- Previous corneal refractive surgery (i.e LASIK, PRK, RK)
- Pupil abnormalities.
- Concurrent infectious/non-infectious uveitis.
- History of chronic intraocular inflammation.
- Visually significant macular disease.
- History of retinal detachment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Florida Eye Specialists
DeLand, Florida, 32720
About this study
Official title: The Purpose of This Research is to Assess Vivity Toric IOL Rotational Stability at the End of Surgery, Post op 1 Day, Post op 1 Week and Post op 4 Weeks. Participants in This Research Study Are 45 Years of Age or Older and Have Planned Implantation in at Least One Eye With an Acrysof IQ Vivity Extended Vision Toric IOL.
The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.
Read the detailed description
Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one eye.
- Conditions
- Cataract
- Being tested
- Alcon Vivity toric intra ocular lens
- Keywords
- Vivity, Cataract, Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon Vivity toric intra ocular lensDevice
implanting vivity toric IOL to asses rotational stability. IOL is already FDA approved for implantation at time of cataract surger. Intervention is to assess rotational stability and visual outcome.
| Study group | Role | What they receive |
|---|---|---|
| vivity toric IOL implantation arm | Experimental | vivity toric intraocular lens will be implanted in one eye and undergo digital imaging intra op and post op to evaluate for toric intraocular lens rotational stability. Receives: Device: Alcon Vivity toric intra ocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational stability of Vivity Toric IOL.
Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks.
Measured: Five months
Secondary outcomes (1)
Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.
Percentage of eyes with post op rotation of five degrees or less, absolute prediction of error ≤ 0.5 D, residual astigmatism ≤ 0.5 D, residual astigmatism 1.00 D.
Monocular and Binocular UDVA, UIVA, UNVA, CDVA, DCIVA and DCNVA.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start30 Sep 2020
- Primary completion5 May 2021
- Study completion19 Aug 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study will include adults (45 years and older) who plan to have cataract extraction and subsequent implantation of AcrySof® IQ Vivity™Extended Vision Toric IOL in at least one eye. Approximately 40 eye will be screened to identify 35 qualified eyes. Within 40 days of screening, qualified subjects will receive cataract surgery followed by implantation of the AcrySof® IQ Vivity™Extended Vision Toric IOL at the surgery visit. If the second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the Screening visit 0. Four postoperative follow up visits are planned to occur at 1-2 days, 7-14 days, and 28-35 days for each enrolled eye. Subject participation in this study is expected to last up to 2 months, including a total of 5 study visits for subjects implanted in one eye and up to 9 visits for subjects implanted in both eyes. Upon completion of the 35 day follow up visit subjects will be exited from the study.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Barber
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research, Eric Rosenberg, D.O.,M.Sc.Eng.
- Responsible party
- Sponsor-investigator, Kevin Barber, Central Florida Eye Specialists, LLC
- Investigators
- Kevin Barber, MD, Principal investigator, Ophthalmologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119127
- Sponsor's protocol ID
- 63171943
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber KM, O'Connor S, Mackinder P, Chih A, Jones B. Rotational stability and refractive outcomes of the DFT/DATx15 toric, extended depth of focus intraocular lens. Int Ophthalmol. 2023 Aug;43(8):2737-2747. doi: 10.1007/s10792-023-02673-7. Epub 2023 Mar 10.
PubMed 36894823
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purpose of This Research is to Assess Vivity Toric IOL Rotational Stability at the End of Surgery, Post op 1 Day, Post op 1 Week and Post op 4 Weeks. Participants in This Research Study Are 45 Years of Age or Older and Have Planned Implantation in at Least One Eye With an Acrysof IQ Vivity Extended Vision Toric IOL.
- ClinicalTrials.gov ID
- NCT05119127
- Acronym / sponsor ID
- 63171943
- Conditions
- Cataract
- Keywords
- Vivity, Cataract, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kevin BarberUniversity, hospital or other
- Collaborators
- Alcon Research, Eric Rosenberg, D.O.,M.Sc.Eng.
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 12 Nov 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.
The purpose of this research is to assess the rotational stability of the AcrySof IQ Vivity Extended Vision Toric IOL and Refractive Visual outcome.
Detailed description
Assessment of the rotational stability and Refractive Visual Outcome of the AcrySof IQ Vivity Extended Vision Toric IOL at the end of surgery, post op 1 day, post op 1 week and post op 4 weeks. Participants in this research study are 45 years of age or older and have planned implantation in at least one eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study will include adults (45 years and older) who plan to have cataract extraction and subsequent implantation of AcrySof® IQ Vivity™Extended Vision Toric IOL in at least one eye. Approximately 40 eye will be screened to identify 35 qualified eyes. Within 40 days of screening, qualified subjects will receive cataract surgery followed by implantation of the AcrySof® IQ Vivity™Extended Vision Toric IOL at the surgery visit. If the second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the Screening visit 0. Four postoperative follow up visits are planned to occur at 1-2 days, 7-14 days, and 28-35 days for each enrolled eye. Subject participation in this study is expected to last up to 2 months, including a total of 5 study visits for subjects implanted in one eye and up to 9 visits for subjects implanted in both eyes. Upon completion of the 35 day follow up visit subjects will be exited from the study.
| Arm | Type | Receives |
|---|---|---|
| vivity toric IOL implantation arm | Experimental | Device: Alcon Vivity toric intra ocular lensvivity toric intraocular lens will be implanted in one eye and undergo digital imaging intra op and post op to evaluate for toric intraocular lens rotational stability. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects undergoing cataract extraction with intraocular lens implantation.
- Age: 45 years and older.
- Willing and able to comply with scheduled visits and other study procedures.
- Subjects who require an IOL power in the range of +15.0 D to +25.0 D.
- Subjects with regular corneal astigmatism that can be treated with T3-T5.
Key exclusion criteria (8 listed)
- Glaucoma.
- Clinically significant corneal dystrophy.
- Previous corneal refractive surgery (i.e LASIK, PRK, RK)
- Pupil abnormalities.
- Concurrent infectious/non-infectious uveitis.
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 |
|---|---|---|
| Alcon Vivity toric intra ocular lensimplanting vivity toric IOL to asses rotational stability. IOL is already FDA approved for implantation at time of cataract surger. Intervention is to assess rotational stability and visual outcome. | Device | vivity toric IOL implantation arm |
Primary outcome
Rotational stability of Vivity Toric IOL.
Time frame: Five months
Rotational stability of Vivity Toric IOL will be measured at post op 1 day, post op 1 week and post op 4 weeks.
1 secondary outcome
Percentage of eyes with residual refractive astigmatism, absolute residual astigmatism prediction error, and monocular distance and intermediate visual acuities.
Time frame: Five months
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 12 Nov 2021.
- Derived from this study: PubMed 36894823Barber KM, O'Connor S, Mackinder P, Chih A, Jones B. Rotational stability and refractive outcomes of the DFT/DATx15 toric, extended depth of focus intraocular lens. Int Ophthalmol. 2023 Aug;43(8):2737-2747. doi: 10.1007/s10792-023-02673-7. Epub 2023 Mar 10.
- Individual participant dataSharing planned: No
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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.
Kevin Barber, MD principal investigator
Ophthalmologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcon Vivity toric intra ocular lens in people with Cataract, run by Kevin Barber 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 7 inclusion and 8 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 12 Nov 2021. 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?
Rotational stability of Vivity Toric IOL. (time frame: Five months). 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 NCT05119127, 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 12 Nov 2021.