IOL Implants for Vision Improvement

Recruiting at 7 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Disqualifiers: Other study, Corneal surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

480 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying the safety and performance of special artificial lenses used in cataract surgery. The study focuses on patients who have already received these lenses. These lenses help improve vision by replacing the eye's cloudy natural lens and focusing light correctly onto the retina.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the Clareon PanOptix and Vivity IOLs unique compared to other vision improvement treatments?

The Clareon PanOptix IOL is unique because it offers an intermediate focal point at 60 cm, which is more comfortable for tasks like using computers and phones, and it uses ENLIGHTEN technology for better light utilization and vision in various lighting conditions. The Clareon Vivity IOL provides extended depth of focus, which helps improve vision at different distances without relying heavily on pupil size. ^{1 2 3 4 5}

Research Team

Clinical Trial Lead, Surgical

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This study is for people who have had bilateral implantation of Clareon Vivity or PanOptix lenses, with or without astigmatism correction (Toric), between 3-6 months ago. Participants must be able to sign a consent form and have their medical history available. Pregnant individuals, those in other studies, or those who've had corneal surgery after lens implantation cannot join.

Inclusion Criteria

Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection

Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form

I had specific lens implants in both eyes 3-6 months ago.

Exclusion Criteria

Subject is currently participating in another investigational drug or device study

Subject is pregnant at the time of enrollment

Other protocol-defined exclusion criteria may apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment.

3-6 months

Prospective Follow-up

Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.

Up to 3 years

Regular visits up to Year 3

Long-term Follow-up

Participants are monitored for safety and performance of the IOLs over a long-term period.

Up to 3 years

Treatment Details

Interventions

• Clareon PanOptix Trifocal IOL - Non Toric
• Clareon PanOptix Trifocal IOL - Toric
• Clareon Vivity IOL - Non Toric
• Clareon Vivity IOL - Toric

Trial Overview The trial aims to assess the long-term safety and effectiveness of two types of intraocular lenses: Clareon Vivity and PanOptix, including versions designed for astigmatism (Toric). It's a follow-up study focusing on patients who already received these implants.

Participant Groups

Group I: Clareon Vivity IOL - Toric Experimental Treatment 1 Intervention

Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.

Group II: Clareon Vivity IOL - Non Toric Experimental Treatment 1 Intervention

Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.

Group III: Clareon PanOptix IOL - Toric Experimental Treatment 1 Intervention

Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.

Group IV: Clareon PanOptix IOL - Non Toric Experimental Treatment 1 Intervention

Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.

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

Approved in United States as AcrySof IQ Clareon PanOptix Trifocal IOL for:

• Visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed

Approved in European Union as Clareon PanOptix Trifocal IOL for:

• Visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed

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 AcrySof IQ PanOptix IOL offers a more natural intermediate focal point of 60 cm, enhancing comfort for tasks like using computers, compared to traditional trifocal IOLs with an 80 cm focal point.

Clinical evidence from 12 studies indicates that the PanOptix IOL provides good visual outcomes and high spectacle independence, similar to other multifocal and extended depth of focus IOLs, but individual patient needs must be considered for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AcrySof IQ PanOptix Intraocular Lens Versus Extended Depth of Focus Intraocular Lens and Trifocal Intraocular Lens: A Clinical Overview. Sudhir, RR., Dey, A., Bhattacharrya, S., et al.[2019]

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 involving 19 eyes from 14 patients with significant preoperative corneal astigmatism (average 4.00 D), high-cylinder power AcrySof toric intraocular lenses (IOLs) effectively reduced residual astigmatism to an average of 0.55 D three months after surgery.

The uncorrected distance visual acuity improved significantly from an average of 1.3 logMAR preoperatively to 0.11 logMAR postoperatively, demonstrating the IOLs' efficacy in enhancing vision after cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-cylinder acrylic toric intraocular lenses: a case series of eyes with cataracts and large amounts of corneal astigmatism. Cervantes-Coste, G., Garcia-Ramirez, L., Mendoza-Schuster, E., et al.[2012]

In a study of 100 eyes from 56 patients, the AcrySof SN60TT toric intraocular lens (IOL) showed comparable higher-order aberrations (HOAs) and optical quality to the non-toric AcrySof SN60AT IOL one year after surgery.

The toric IOL effectively corrected corneal astigmatism with a low residual refractive astigmatism of 0.44 D, indicating stable postoperative alignment and good optical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo assessment of higher-order aberrations after AcrySof toric intraocular lens implantation: a comparative study. Scialdone, A., Raimondi, G., Monaco, G.[2017]

In a study involving 71 patients who received bilateral implantation of either the PanOptix or Trinova trifocal intraocular lenses, the PanOptix IOL demonstrated significantly better intermediate and near visual acuity compared to the Trinova IOL at a 3-month follow-up.

Both IOLs were found to be safe, with no adverse events reported, making the PanOptix IOL a strong option for patients looking to reduce their dependence on glasses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Visual Outcomes of Two Trifocal IOLs. Kılıç, A., Özpınar, A., Tanrıverdi, C.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

AcrySof IQ PanOptix Intraocular Lens Versus Extended Depth of Focus Intraocular Lens and Trifocal Intraocular Lens: A Clinical Overview. [2019]

2. England pubmed.ncbi.nlm.nih.gov

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

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

High-cylinder acrylic toric intraocular lenses: a case series of eyes with cataracts and large amounts of corneal astigmatism. [2012]

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

In vivo assessment of higher-order aberrations after AcrySof toric intraocular lens implantation: a comparative study. [2017]

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

Comparison of Visual Outcomes of Two Trifocal IOLs. [2023]