Accommodating IOL for Cataracts

Not yet recruiting at 4 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must not be taking: Risk-increasing medications

Disqualifiers: Pregnancy, Glaucoma, Ocular hypertension, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of two new lens implants, AAL-FAIOL and BAL-FAIOL, for people with cataracts. Cataracts cloud the eye's natural lens, making clear vision difficult. The study will replace the cloudy lens with one of these new implants to determine if they improve vision. People with cataracts in both eyes and low levels of astigmatism (a common vision problem) might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to advancing cataract treatment options.

Do I need to stop my current medications for the trial?

The trial excludes people taking medications that could increase risk or affect accommodation, so you might need to stop certain medications. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that certain types of intraocular lenses (IOLs), such as AAL-FAIOL and BAL-FAIOL, have been promising in past studies. Recipients of these lenses generally reported satisfaction with their vision even years after surgery, indicating good tolerance.

For the AAL-FAIOL, earlier studies focused on safety and ease of use have shown that the lens can improve vision without causing major side effects. Similarly, the BAL-FAIOL has been tested for its design and effectiveness, yielding positive safety results over a 12-month period.

These lenses are still under study, so ongoing research is necessary to confirm their long-term safety and effectiveness. However, current data is encouraging for those considering participation in such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, AAL-FAIOL and BAL-FAIOL, because they represent a potential leap forward for cataract patients. Unlike traditional intraocular lenses that remain static after implantation, these accommodating lenses are designed to mimic the natural lens’s ability to focus at different distances. This could significantly improve vision quality by reducing the need for glasses or contact lenses after surgery. By using an innovative phacoemulsification method to remove the clouded lens and then implanting these advanced lenses, the treatments aim to enhance visual outcomes and overall patient satisfaction.

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

Studies have shown that accommodating intraocular lenses (IOLs), such as AAL-FAIOL and BAL-FAIOL, may improve vision in people with cataracts. In this trial, participants will receive either the AAL-FAIOL or the BAL-FAIOL lens. Early reports suggest that over 95% of eyes with these lenses exhibit better vision flexibility, allowing easier focus at different distances. In one small study, patients improved their vision from 20/40 to 20/25 or better after surgery. Many patients remain satisfied with these lenses even years later, indicating long-term effectiveness. Researchers are studying these lenses for their potential to restore full vision range, offering hope for those with cataracts. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Trial Lead, Surgical

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with bilateral cataracts that need removal and have less than or equal to 1.50 D of corneal astigmatism in both eyes. Participants must understand and sign a consent form, be able to attend all study visits, and meet other specific criteria.

Inclusion Criteria

Key

I can understand and sign a consent form.

I can attend all required study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo cataract surgery with AAL-FAIOL or BAL-FAIOL implantation in one eye, with surgeries separated by 14-35 days

5 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with potential laser adjustments to the AAL lens

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AAL-FAIOL

Trial Overview The study is testing the safety, usability, and effectiveness of a new intraocular lens (IOL) called AAL-FAIOL after cataract removal by phacoemulsification surgery. It compares this IOL with another type known as BAL-FAIOL.

How Is the Trial Designed?

Group I: BAL-FAIOL Experimental Treatment 2 Interventions

The clouded lens will be removed by phacoemulsification, after which the BAL-FAIOL will be implanted in one eye.

Group II: AAL-FAIOL Experimental Treatment 2 Interventions

The clouded lens will be removed by phacoemulsification, after which the AAL-FAIOL will be implanted in one eye.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05317728

Clinical Study of a Fluid Accommodating Intraocular Lens ... The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6239103/

Patient-reported outcomes of multifocal and accommodating ... The majority of patients who received either accommodating or multifocal IOLs remain satisfied with their lens of choice more than 5 years after the original ...

3. ophthalmologymanagement.com ophthalmologymanagement.com/issues/2025/september/the-holy-grail-of-cataract-surgery/

The Holy Grail of Cataract Surgery Accommodative intraocular lenses under investigation show promise for restoring a full range of vision in the pseudophakic patient.

4. aao.org aao.org/education/current-insight/accommodating-iols-current-technology-limitations-

Accommodating IOLs: Current Technology, Limitations ... Initial reports of close to 100 eyes implanted with this lens have demonstrated that more than 95% of eyes have accommodative amplitudes of more ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2162098923003997

Review Article Accommodating Intraocular Lenses A pilot study in 6 subjects with preoperative BCDVA of 20/40 or worse showed all achieved best-corrected vision of 20/25 or better and a mean objective ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07147192

Feasibility Study of an Accommodating IOL Design The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will ...

7. europe.ophthalmologytimes.com europe.ophthalmologytimes.com/view/aao-2024-two-year-clinical-feasibility-trial-outcomes-for-a-dual-optic-iol-system-for-the-treatment-of-presbyopia-and-cataract

AAO 2024: Two-year clinical feasibility trial outcomes for a ... AAO 2024: Two-year clinical feasibility trial outcomes for a dual-optic IOL system for the treatment of presbyopia and cataract · Play · LIVE.