Clareon Vivity Toric IOL vs LAL+ for Cataracts

Overseen By Alisha Polson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Eye Associates

Must not be taking: UV sensitivity drugs

Disqualifiers: Corneal pathology, Macular disease, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that increase sensitivity to UV light or may harm the retina.

Is the Clareon Vivity Toric IOL safe for humans?

Research on toric intraocular lenses (IOLs), including the Clareon model, shows they are generally safe for use in cataract surgery, with studies focusing on their safety and effectiveness in correcting vision issues like astigmatism (a condition where the eye does not focus light evenly on the retina). ^{1 2 3 4 5}

How does the Clareon Vivity Toric IOL treatment for cataracts differ from other treatments?

The Clareon Vivity Toric IOL is unique because it combines the benefits of a toric intraocular lens (IOL), which corrects astigmatism (an imperfection in the eye's curvature), with advanced lens technology that provides a broader range of vision without glasses. This makes it different from standard cataract treatments that may not address astigmatism or offer enhanced vision quality. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Cathleen M McCabe, MD

Principal Investigator

The Eye Associates of Manatee

Eligibility Criteria

This trial is for adults with age-related cataracts and regular astigmatism who have not yet had surgery. Participants must be suitable for bilateral implantation of LAL+ IOLs in Phase 1, or willing to be randomly assigned to receive either LAL+ or Clareon Vivity Toric IOLs in Phase 2.

Inclusion Criteria

Subjects will have an expected monocular BCDVA outcomes of 20/25 or better in the opinion of the investigator

My eye condition can be corrected with a specific lens for astigmatism.

Subjects will be required to have a dilated pupil diameter of 7 mm or greater in both eyes

Exclusion Criteria

I have severe dry eye condition.

Irregular astigmatism

I have a history of glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Ambispective, multi-site, single arm study in age-related cataract patients treated with LAL+ IOLs

Phase 2 Treatment

Prospective, randomized, unmasked, comparative study with subjects randomized to LAL+ or Clareon Vivity Toric IOLs

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• Clareon Vivity Toric IOL
• LAL+

Trial Overview The study examines visual outcomes using two types of lens implants after cataract surgery: the RxSight LAL+ and Alcon's Clareon Vivity Toric IOL. Phase 1 observes patients with LAL+, while Phase 2 compares both lenses over a period of three months.

Participant Groups

Group I: LAL+ Experimental Treatment 1 Intervention

Group II: Clareon Vivity Toric IOLs Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Eye Associates

Lead Sponsor

Trials

3

Recruited

380+

Findings from Research

In a study of 117 patients undergoing bilateral implantation of toric intraocular lenses (IOLs) for cataracts and astigmatism, 99% achieved a binocular uncorrected distance visual acuity of 20/40 or better, demonstrating high efficacy in improving vision.

Patients reported high satisfaction with their vision post-surgery, with 94% rating their satisfaction as 7 or higher, and 69% of patients reported never needing distance spectacles after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual function and patient experience after bilateral implantation of toric intraocular lenses. Ahmed, II., Rocha, G., Slomovic, AR., et al.[2022]

In a study involving 350 adults undergoing cataract surgery, 99.7% of participants achieved excellent visual acuity (CDVA ≤0.3 logMAR) 12 months after receiving the Clareon intraocular lens (IOL), indicating its high effectiveness.

The safety profile of the Clareon IOL was favorable, with serious adverse events occurring in less than 1% of subjects, and the most common nonserious issue being posterior capsule opacification in 5.4% of cases, which is within expected limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Lehmann, R., Maxwell, A., Lubeck, DM., et al.[2022]

In a study of 30 patients undergoing combined 23-gauge microincisional vitrectomy and cataract surgery, the AcrySof toric intraocular lens (IOL) significantly improved uncorrected visual acuity compared to the non-toric IOL at 1, 3, and 6 months post-surgery.

The toric IOL group also had a lower mean absolute residual refractive cylinder, indicating better astigmatism correction, while demonstrating good rotational stability, with 66.7% of lenses remaining within 5° of their intended axis after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. Park, DH., Shin, JP., Kim, SY.[2022]

In a study of 20 patients undergoing combined microincision vitrectomy and cataract surgery, those receiving toric intraocular lenses (IOLs) had significantly better uncorrected visual acuity compared to those with non-toric IOLs at all postoperative time points up to 24 months.

The toric IOLs demonstrated excellent rotational stability, with 80% of lenses remaining within 5° of their intended axis after 24 months, making them a reliable option for correcting corneal astigmatism in patients with vitreoretinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. Lee, JY., Kang, KM., Shin, JP., et al.[2013]

References

1. India pubmed.ncbi.nlm.nih.gov

The use of toric intraocular lens to correct astigmatism at the time of cataract surgery. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of a new toric presbyopia-correcting posterior chamber silicone intraocular lens. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Toric Intraocular Lenses in the Correction of Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Visual function and patient experience after bilateral implantation of toric intraocular lenses. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Astigmatism-Correcting Efficiency and Rotational Stability after Cataract Surgery with a Double-Loop Haptic Toric Intraocular Lens: A 1-Year Follow-Up. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Combined 23-gauge microincisonal vitrectomy surgery and phacoemulsification with AcrySof toric intraocular lens implantation: a comparative study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Two-year results of AcrySof toric intraocular lens implantation in patients with combined microincision vitrectomy surgery and phacoemulsification. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical and refractive outcomes of cataract surgery with toric intraocular lens implantation at a resident-teaching institution. [2011]