Intraocular Lens Implants for Cataracts

Recruiting at 1 trial location

Overseen By Tetiana Huff

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Berkeley Eye Center

Disqualifiers: Pregnancy, Glaucoma, Retinal diseases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Clareon PanOptix, Clareon PanOptix PRO, Mix-and-Match PanOptix/Vivity for cataracts?

Research shows that using a mix-and-match approach with different types of intraocular lenses (IOLs) can lead to good visual outcomes and patient satisfaction. Specifically, the trifocal PanOptix IOL has been shown to provide good near vision and overall visual quality. ^{1 2 3 4 5}

Is the Clareon PanOptix intraocular lens safe for humans?

Research shows that the Clareon intraocular lens, including models like PanOptix, has been studied for safety in humans, with studies indicating it is generally safe over periods ranging from 12 months to 3 years. ^{4 6 7 8 9}

How is the Clareon PanOptix treatment for cataracts different from other treatments?

The Clareon PanOptix treatment for cataracts is unique because it uses a trifocal intraocular lens (IOL) that provides a more natural and comfortable working distance for tasks like using computers and mobiles, thanks to its intermediate focal point of 60 cm. It also utilizes ENLIGHTEN optical technology, which ensures high light energy utilization and consistent vision quality in various lighting conditions, offering a broader range of clear vision compared to traditional trifocal IOLs. ^{1 2 10 11 12}

What is the purpose of this trial?

Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.

Research Team

Morgan Micheletti, MD

Principal Investigator

Berkeley Eye Center

Eligibility Criteria

This trial is for adults over 40 with age-related cataracts who need surgery in both eyes. They must understand and sign a consent form, be able to attend all study visits, have good potential post-surgery vision, and correctable corneal astigmatism.

Inclusion Criteria

Ability to understand and sign an ethics committee-approved informed consent form

Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator

Ability to understand and complete questionnaires

Exclusion Criteria

Participation in another clinical study that could interfere with the results

Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments

RMS total higher-order aberrations (HOAs) >0.70 µm or coma >0.40 µm as measured by tomography or topography with a 4 mm pupil setting

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Initial enrollment period with three-arm study comparing different intraocular lens implantations

8-12 weeks

Stage 2 Treatment

Head-to-head study refined based on Stage 1 data

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Clareon PanOptix
• Clareon PanOptix PRO
• Mix-and-Match PanOptix/Vivity

Trial Overview The study compares three types of lens implants after cataract surgery: Clareon PanOptix, Clareon PanOptix Pro, and a combination of PanOptix Pro/Vivity lenses. It's randomized and masked with two stages; the second stage depends on initial results.

Participant Groups

Group I: Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye Experimental Treatment 1 Intervention

Group II: Bilateral Clareon PanOptix Pro IOL implantation Experimental Treatment 1 Intervention

Group III: Bilateral Clareon PanOptix IOL implantation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Berkeley Eye Center

Lead Sponsor

Trials

5

Recruited

1,000+

Sengi

Industry Sponsor

Trials

28

Recruited

2,100+

Findings from Research

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]

The Clareon single-piece intraocular lens (IOL) demonstrated excellent long-term effectiveness, with 99.5% of eyes achieving a corrected distance visual acuity (CDVA) of ≤0.3 logMAR at 1 year and 93.4% achieving 0.1 logMAR or better at 3 years, indicating stable visual outcomes over time.

The safety profile of the Clareon IOL was strong, with low rates of adverse events, 100% of lenses showing no significant glistenings, and 92.9% of eyes having no or clinically nonsignificant posterior capsule opacification (PCO) after 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens. Nuijts, RMMA., Bhatt, U., Nanavaty, MA., et al.[2023]

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]

The new acrylic one-piece toric intraocular lens (IOL) demonstrated effective outcomes, with 54.8% of eyes achieving the primary endpoint of 20/20 vision or better six months after surgery, and good visual acuity maintained one year postoperatively.

The IOL showed stability in alignment and low rates of complications, with only three eyes needing repositioning and two requiring Nd:YAG laser capsulotomy, indicating its safety and reliability for patients with corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microincision Hydrophobic Acrylic Aspheric Toric Intraocular Lens for Astigmatism and Cataract Correction. Bissen-Miyajima, H., Negishi, K., Hieda, O., et al.[2015]

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Visual Results Following Implantation of a Refractive Multifocal Intraocular Lens in One Eye and a Diffractive in the Contralateral Eye. [2022]

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

Visual performance and patient satisfaction after implantation of extended range-of-vision IOLs: bilateral implantation vs 2 different mix-and-match approaches. [2021]

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

Clinical outcomes with a diffractive trifocal intraocular lens. [2018]

4. 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]

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

Bilateral mix-and-match versus unilateral multifocal intraocular lens implantation: long-term comparison. [2022]

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

Three-year multinational clinical study on an aspheric hydrophobic acrylic intraocular lens. [2023]

7. 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]

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

Long-term Clinical Outcomes After Trifocal Intraocular Lens Implantation: A Retrospective Observational Study. [2023]

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

Microincision Hydrophobic Acrylic Aspheric Toric Intraocular Lens for Astigmatism and Cataract Correction. [2015]

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

Observation of Visual Quality after Femtosecond Laser-Assisted Cataract Surgery Combined with Trifocal Intraocular Lens Implantation. [2022]

11. 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]

12. Germany pubmed.ncbi.nlm.nih.gov

[Special intra-ocular lenses]. [2008]