Clareon Toric IOL for Astigmatism

Recruiting at 6 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Pregnancy, Retinal detachment, Glaucoma, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the Clareon Toric IOL treatment for astigmatism?

The Clareon Toric IOL is made from a new hydrophobic acrylic material designed for better clarity and resistance to glistening, which has been shown to be effective and safe in a similar type of intraocular lens over a three-year period. Additionally, the AcrySof Toric IOL, which is similar to the Clareon Toric IOL, has been shown to effectively correct corneal astigmatism and maintain stability in the eye. ^{1 2 3 4 5}

Is the Clareon Toric IOL safe for humans?

Research indicates that toric intraocular lenses (IOLs), like the Clareon Toric IOL, are generally safe for correcting astigmatism in cataract patients, with studies evaluating their safety and stability. ^{6 7 8 9 10}

How is the Clareon Toric IOL treatment different from other treatments for astigmatism?

The Clareon Toric IOL is unique because it uses a new hydrophobic acrylic material designed for enhanced clarity and greater resistance to glistening, which may improve visual outcomes compared to other intraocular lenses used for astigmatism. ^{2 3 4 5 11}

Research Team

Clinical Trial Management Operations, Surgical

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This trial is for individuals with cataracts and astigmatism who need their cataracts removed by standard surgery. Participants must be able to understand and sign a consent form, have no major eye diseases like glaucoma or macular degeneration, not be pregnant or nursing, and commit to all study visits.

Inclusion Criteria

Other protocol-defined inclusion criteria may apply

I can attend all required study visits.

I have astigmatism in the eye(s) that will be operated on.

Exclusion Criteria

Clinically significant dry eye that would affect study measurements based on the Investigator's expert medical opinion

Other protocol-defined exclusion criteria may apply

I have had eye problems like retinal detachment or glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative

Preoperative assessment and preparation for cataract surgery

1-2 weeks

1 visit (in-person)

Surgical

Clareon Toric IOL implanted in one or both eyes during cataract surgery

1-2 weeks

Up to 2 visits (in-person)

Postoperative

Postoperative monitoring and assessment of IOL performance

3 months

Up to 9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Regular visits at Month 6, Year 1, Year 3

Treatment Details

Interventions

• Clareon Toric IOL

Trial Overview The study is evaluating the long-term safety and effectiveness of Clareon Toric Intraocular Lenses (IOLs) when used in patients undergoing cataract surgery to correct vision problems caused by astigmatism.

Participant Groups

Group I: Clareon Toric IOL Experimental Treatment 2 Interventions

Clareon Toric IOL implanted in one or both eyes during cataract surgery

Clareon Toric IOL is already approved in United States, European Union for the following indications:

Approved in United States as Clareon Toric for:

• Visual correction of aphakia and pre-existing corneal astigmatism in adult patients following cataract surgery

Approved in European Union as Clareon Toric for:

• Visual correction of aphakia and pre-existing corneal astigmatism in adult patients following cataract surgery

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Findings from Research

The study involved 19 eyes from 13 patients with significant preexisting corneal astigmatism, showing that the Z-flex 690TA toric intraocular lens effectively corrected astigmatism with 100% of eyes achieving a spherical equivalent within ± 1.00 D of the target refraction after surgery.

With a mean follow-up of 4.3 months, the implantation of the Z-flex 690TA IOL demonstrated safety and predictability, with minimal misalignment and a correction ratio indicating effective astigmatism correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of cataract surgery with Z-flex hydrophilic acrylic toric IOL. Einan-Lifshitz, A., Barkana, Y., Goldich, Y., et al.[2017]

The three-piece hydrophobic monofocal intraocular lens (IOL) Model MA60NM demonstrated effective visual correction, with 95.5% of patients achieving a Best Spectacle-Corrected Visual Acuity (BSCVA) of 20/40 or better at 1 year, surpassing ISO grid rates.

The safety profile of the MA60NM lens was strong, with low rates of serious adverse events and clinically significant posterior capsular opacification (PCO) at 1.1% at 1 year and 2.2% at 3 years, indicating long-term safety and effectiveness of the Clareon® material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Maxwell, A., Suryakumar, R.[2022]

In a study of 143 eyes from 141 patients, both Eyecryl toric and Alcon AcrySof IQ toric intra-ocular lenses (IOLs) demonstrated similar uncorrected distance visual acuity (UCVA) and residual astigmatism one month after surgery, indicating comparable effectiveness in treating astigmatism.

However, the Eyecryl toric IOL showed statistically better best corrected distance visual acuity (BCVA) compared to the Alcon IOL, suggesting a potential advantage in visual clarity for patients receiving the Eyecryl lens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes of Eyecryl toric and Alcon toric intra-ocular lenses - A real world study. Korpole, NR., Kurada, P., Kuzhuppilly, NIR., et al.[2023]

In a study of 517 subjects, the AcrySof Toric intraocular lens (IOL) demonstrated superior visual acuity outcomes compared to a spherical control IOL, with 77.7% of patients achieving 20/20 vision or better after one year.

The AcrySof Toric IOL also showed excellent rotational stability, with an average rotation of less than 4°, and significantly higher rates of spectacle freedom (61.0% vs. 36.4% for the control IOL), indicating its effectiveness for patients with cataracts and corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. Holland, E., Lane, S., Horn, JD., et al.[2022]

The AcrySof Toric intraocular lens (IOL) effectively corrects corneal astigmatism ranging from 0.67 to 4.11 diopters, providing good clinical outcomes and excellent stability over time, although some studies report minor overcorrections or undercorrections.

Improvements to the manufacturer's online calculator for this IOL could enhance accuracy by accounting for posterior corneal astigmatism and the variable distance between the IOL and cornea, which affects the conversion of IOL cylinder measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new slant on toric intraocular lens power calculation. Savini, G., Hoffer, KJ., Ducoli, P.[2013]

In a study of 41 patients with moderate astigmatism undergoing cataract surgery, the combination of trifocal intraocular lenses (IOLs) with femtosecond laser-assisted arcuate keratotomy (FSAK) provided better uncorrected intermediate visual acuity compared to bifocal toric IOLs, especially at 1 and 3 months post-surgery.

While both methods effectively reduced astigmatism, the bifocal toric IOLs demonstrated more stable long-term astigmatism correction, suggesting that a mix-and-match approach could optimize visual outcomes across different distances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of astigmatism correction and visual outcomes in mix-and-match implantations of trifocal intraocular lenses with femtosecond laser-assisted arcuate keratotomy and contralateral bifocal Toric intraocular lenses. Shen, J., Hua, Z., Zhang, L., et al.[2023]

In a study involving 11 eyes from 8 patients with stable pellucid marginal degeneration (PMD), cataract surgery with a hydrophobic toric intraocular lens (IOL) significantly improved corrected distance visual acuity (CDVA) from a mean of 0.62 logMAR preoperatively to 0.07 logMAR postoperatively.

The procedure also resulted in a significant reduction in refractive astigmatism, demonstrating both safety and efficacy, with minimal axis rotation of the toric IOL (<5°) at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-incision cataract surgery and toric lens implantation for the reduction of high myopic astigmatism in patients with pellucid marginal degeneration. Balestrazzi, A., Baiocchi, S., Balestrazzi, A., et al.[2022]

In a study of 332 eyes that received plate-haptic multifocal toric intraocular lenses (IOLs), 3.3% experienced extensive misalignment of 45º or more, indicating a relatively low incidence of this complication.

Eyes with extensive misalignment had significantly greater axial lengths, larger corneal diameters, and flatter corneas, suggesting that these anatomical factors may contribute to the risk of misalignment after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extensive misalignment of plate-haptic rotationally asymmetric multifocal toric intraocular lens. Oshika, T., Nakano, S., Inamura, M., et al.[2023]

In a study involving 110 patients, the Clareon IOL showed a higher intensity of posterior capsule opacification (PCO) one month after surgery compared to the Tecnis IOL, indicating a potential early difference in PCO development.

By 12 months post-implantation, there were no significant differences in visual function or PCO between the two IOLs, suggesting that both lenses perform similarly in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of posterior capsule opacification between Clareon CNA0T0 and Tecnis ZCB00 intraocular lenses. Almenara, C., Bartol-Puyal, FA., Soriano, D., et al.[2022]

In a study of 57 cataract patients, toric intraocular lens (IOL) implantation significantly improved uncorrected visual acuity (UCVA) from a preoperative log MAR of 0.87 to 0.31 one year post-surgery, indicating its efficacy in correcting moderate-to-high corneal astigmatism.

The procedure was found to be safe, with a low spectacle dependence rate of 68.42% and minimal residual astigmatism (1.18 D) after surgery, demonstrating the stability of toric IOLs in long-term vision correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toric Intraocular Lens Implantation in the Correction of Moderate-To-High Corneal Astigmatism in Cataract Patients: Clinical Efficacy and Safety. Qiu, X., Shi, Y., Han, X., et al.[2022]

The study involved 98 eyes from 88 patients with low corneal astigmatism, showing that the AcrySof IQ Toric SN6AT2 intraocular lens (IOL) significantly reduced postoperative astigmatism from a mean of 0.38 D to 0.13 D, indicating effective correction.

Post-surgery, 96% of the eyes achieved a spherical equivalent refraction within 0.50 D of the target, demonstrating that this IOL provides reliable visual outcomes and is a safe option for cataract surgery in patients with low astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cataract Surgery in Eyes with Low Corneal Astigmatism: Implantation of the Acrysof IQ Toric SN6AT2 Intraocular Lens. Aujla, JS., Vincent, SJ., White, S., et al.[2020]

References

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

Results of cataract surgery with Z-flex hydrophilic acrylic toric IOL. [2017]

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

Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes of Eyecryl toric and Alcon toric intra-ocular lenses - A real world study. [2023]

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

The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. [2022]

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

A new slant on toric intraocular lens power calculation. [2013]

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

Comparison of astigmatism correction and visual outcomes in mix-and-match implantations of trifocal intraocular lenses with femtosecond laser-assisted arcuate keratotomy and contralateral bifocal Toric intraocular lenses. [2023]

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

Mini-incision cataract surgery and toric lens implantation for the reduction of high myopic astigmatism in patients with pellucid marginal degeneration. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Extensive misalignment of plate-haptic rotationally asymmetric multifocal toric intraocular lens. [2023]

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

Comparison of posterior capsule opacification between Clareon CNA0T0 and Tecnis ZCB00 intraocular lenses. [2022]

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

Toric Intraocular Lens Implantation in the Correction of Moderate-To-High Corneal Astigmatism in Cataract Patients: Clinical Efficacy and Safety. [2022]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Cataract Surgery in Eyes with Low Corneal Astigmatism: Implantation of the Acrysof IQ Toric SN6AT2 Intraocular Lens. [2020]