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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new types of lenses for individuals with cataracts, which are cloudy areas in the eye that impair vision. The study tests three different lens options: Clareon PanOptix, Clareon PanOptix PRO, and a Mix-and-Match PanOptix/Vivity approach, to determine which best improves sight after cataract surgery. It targets adults scheduled for cataract surgery in both eyes who do not have other serious eye conditions. Participants should expect to see well after the surgery and must commit to all study visits. As a Phase 4 trial, this study involves FDA-approved lenses and aims to understand their benefits for more patients.

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 is the safety track record for these treatments?

Studies have shown that most patients express high satisfaction with the Clareon PanOptix Pro lens, with about 99.2% stating they would choose it again. This suggests the lens is generally safe and well-tolerated.

Research indicates that combining Clareon PanOptix and Vivity lenses results in patient satisfaction with vision outcomes. This strategy may provide the benefits of both lenses, enhancing the overall experience.

Since this trial is in Phase 4, these lenses have already received approval for use, strongly suggesting their safety in treating cataracts. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional intraocular lenses for cataracts, the Clareon PanOptix and Clareon PanOptix PRO offer advanced multifocal capabilities that aim to provide clearer vision at multiple distances, reducing the need for glasses after surgery. Researchers are particularly excited about the Mix-and-Match approach, which combines the Clareon PanOptix PRO in one eye with the Clareon Vivity lens in the other eye. This strategy is designed to optimize the benefits of both lenses, enhancing both near and intermediate vision while maintaining quality distance vision. These innovative lenses could significantly improve quality of life by offering a more seamless visual experience.

What evidence suggests that this trial's treatments could be effective for cataracts?

Research has shown that Clareon PanOptix Pro lenses, which participants in this trial may receive, are highly effective, utilizing 94% of available light to enhance vision at different distances. These lenses scatter 50% less light than other trifocal lenses, potentially improving vision quality. Another treatment option in this trial combines Clareon PanOptix and Vivity lenses, which has led to high patient satisfaction; 94% of patients reported satisfaction with their vision and expressed willingness to choose the same lenses again. Overall, these treatments have proven effective for individuals with cataracts, aiding clear vision at various distances. ^{3 4 6 7 8}

Who Is on the Research Team?

Morgan Micheletti, MD

Principal Investigator

Berkeley Eye Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

Citations

1. myalcon.com myalcon.com/professional/insights/clareon-panoptix-pro-expert-perspectives/

Clareon®️ PanOptix®️ Pro: Surgeons Share Early Insights 50% less light scatter, the lowest reported light scatter of any trifocal IOL. · Unprecedented 94% light utilization in trifocal IOLs, compared ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11495208/

The Clareon Vs AcrySof PanOptix Trifocal IOL Significantly more AcrySof (66%) than Clareon (42%) patients achieved a spherical equivalent outcome within 0.25 D of target. Best corrected ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07076277

Visual Outcomes in Patients Contralaterally Implanted With ... Subjects randomized to this arm will receive bilateral cataract surgery with implantation of Alcon Clareon PanOptix Pro or PanOptix Pro Toric IOLs in both eyes.

4. ajo.com ajo.com/article/S0002-9394(24)00351-9/pdf

Functional Outcomes After Refractive Lens Exchange With ... In conclusion, we observed good functional outcomes from far to near distances with the recently introduced Clareon PanOptix IOL in RLE ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002939424003519

Functional Outcomes After Refractive Lens Exchange With ... In conclusion, we observed good functional outcomes from far to near distances with the recently introduced Clareon PanOptix IOL in RLE patients.

6. myalcon.com myalcon.com/professional/cataract-surgery/iols/clareon-panoptix-pro/

Clareon® PanOptix® Pro Trifocal IOL - MyAlcon Undeniable Patient Satisfaction · PanOptix® is a trusted choice · 99.2% of PanOptix® patients would have the same lens implanted again · 98.4% of PanOptix® ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07161635

Post Market Clinical Evaluation of Clareon PanOptix Pro ... The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants ...

8. myalcon.com myalcon.com/professional/cataract-surgery/iols/clareon-panoptix/

Clareon® Panoptix® IOL | Alcon Professional - MyAlcon Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample.