CataractNCT06574646
Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
A study testing LAL+ and Clareon Vivity Toric IOL in people with Cataract, run by The Eye Associates at 1 site in United States.
Trial summary
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- LAL+ and Clareon Vivity Toric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 1 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser;
- All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
- Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
- Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
- Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;
Who cannot join
- Moderate-severe corneal pathology;
- Irregular astigmatism;
- Subject desire monovision correction;
- Preexisting macular disease or other retinal degenerative diseases that is expected to cause future vision loss;
- History of glaucoma;
- Severe dry eye disease;
Show all 14Show fewer
- History of uveitis;
- History of ocular herpes simplex virus;
- History of nystagmus;
- Zonular laxity or dehiscence;
- History psueudoexfoliation;
- History of corneal refractive and intraocular surgery or requiring any other planned ocular surgical procedures;
- Currently taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina;
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Alisha Polson contact
United States1 site
The Eye Associates of Manatee, LLP
Bradenton, Florida, 34209
Matthew Pippin, 941-220-5987, mpippin@theeyeassociates.com
Cathleen McCabe, MD
About this study
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs
Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.
- Conditions
- Cataract
- Being tested
- LAL+, Clareon Vivity Toric IOL
- Keywords
- intraocular lens, LAL+, Clareon Vivity Toric IOLs
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAL+Device
LAL+ IOL allows for refractive error (both sphere and cylinder) enhancements post-IOL implantation by exposing the IOL to ultraviolet (UV) light through a series of noninvasive treatments with a Light Delivery Device.
Clareon Vivity Toric IOLDevice
Clareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology.
| Study group | Role | What they receive |
|---|---|---|
| LAL+ | Experimental | Not described Receives: Device: LAL+ |
| Clareon Vivity Toric IOLs | Active comparator | Not described Receives: Device: Clareon Vivity Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Measured: at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathleen McCabe MD, The Eye Associates
- Investigators
- Cathleen M McCabe, MD, Principal investigator, The Eye Associates of Manatee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574646
- Sponsor's protocol ID
- A126-101
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Acuity Outcome Differences Between the Alcon Vivity Toric IOL and RxSight LAL+
- ClinicalTrials.gov ID
- NCT06574646
- Acronym / sponsor ID
- A126-101
- Conditions
- Cataract
- Keywords
- intraocular lens, LAL+, Clareon Vivity Toric IOLs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The Eye AssociatesUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 28 Aug 2024 (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.
Phase 1 will be ambispective, multi-site, single arm study in age-related cataract patients with regular astigmatism, who were bilaterally treated with the LAL+ IOLs
Phase 2 will be a prospective, randomized, unmasked, comparative, multi-site study with 90 days of follow up. Subjects will be randomized in a 1:1 manner to LAL+ or Clareon VIvity Toric IOLs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAL+ | Experimental | Device: LAL+ |
| Clareon Vivity Toric IOLs | Active comparator | Device: Clareon Vivity Toric IOL |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (≥45) subjects who are astigmatic and require bilateral, routine small-incision, surgery for age-related cataracts with femtosecond laser;
- All subjects will be required to be targeted for refractive emmetropia (plano or first minus closest to plano);
- Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator;
- Subjects will have regular corneal astigmatism (1.00 to 2.00 D), which can be corrected with a toric power IOL of T3-T5;
- Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes;
Key exclusion criteria (14 listed)
- Moderate-severe corneal pathology;
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 |
|---|---|---|
| LAL+LAL+ IOL allows for refractive error (both sphere and cylinder) enhancements post-IOL implantation by exposing the IOL to ultraviolet (UV) light through a series of noninvasive treatments with a Light Delivery Device. | Device | LAL+ |
| Clareon Vivity Toric IOLClareon Vivity Toric IOL utilizes an extended depth of focus (EDOF) design, which incorporates nondiffractive wavefront shaping (X-WAVE) technology. | Device | Clareon Vivity Toric IOLs |
Primary outcome
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Time frame: at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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.
Alisha Polson contact
Cathleen M McCabe, MD principal investigator
The Eye Associates of Manatee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAL+ and Clareon Vivity Toric IOL in people with Cataract, run by The Eye Associates 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathleen McCabe, MD (941-220-5987, cmccabe13@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm (time frame: at the 90-day post-op visit or at least 1 week after final lock-in if longer than 3 months for LAL+ implanted subjects and >2 weeks post YAG, if done.). 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 28 Aug 2024.