LAL + LDD for Cataracts

No longer recruiting at 15 trial locations

Overseen By Hunter Newsom, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RxSight, Inc.

Must not be taking: UV-sensitive drugs, Tamoxifen

Disqualifiers: Macular disease, Dense cataracts, Uveitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of lens, called a Light Adjustable Lens (LAL), for people needing cataract surgery. The goal is to determine if this lens is as safe as the standard monofocal lens. Participants will undergo cataract surgery and be randomly assigned to receive either the LAL or the standard lens. Ideal candidates for the trial need cataract surgery, can read and write in English, and do not have any other serious eye conditions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cataract treatment options.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any systemic medications that may increase sensitivity to UV light or are toxic to the retina, like tamoxifen.

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

Research has shown that the Light Adjustable Lens (LAL) is generally safe. In one study, 92% of patients who received the LAL achieved their desired vision correction, indicating that the device is well-tolerated. However, specific risks exist, such as unexpected changes in vision after eye exposure. The FDA has already approved the LAL for certain uses, supporting its safety. It is important to consult a doctor to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard intraocular lenses (IOLs) used for cataract treatment, the Light Adjustable Lens (LAL) is unique because it can be customized after implantation. This lens allows for adjustments using a Light Delivery Device (LDD) to fine-tune vision based on the patient's needs, offering a personalized approach. Researchers are excited about this innovation because it has the potential to improve visual outcomes significantly, allowing for precise corrections that are not possible with traditional IOLs. Additionally, this technology could reduce the need for additional corrective eyewear, making post-surgery life more convenient for patients.

What evidence suggests that the Light Adjustable Lens (LAL) and Light Delivery Device (LDD) are effective for cataracts?

Research has shown that the Light Adjustable Lens (LAL), which participants in this trial may receive, performs effectively in cataract surgery. One study found that 96% of patients achieved vision close to their desired outcome, with 56% reaching 20/20 vision or better. Other studies indicate that LAL provides clear vision at various distances, including near, middle, and far. This lens can be adjusted after surgery, offering a flexible option for improving vision. Overall, evidence supports that LAL can significantly enhance vision for people with cataracts. Another group in this trial will receive the Control IOL, serving as an active comparator. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 40-80 who are willing to undergo cataract surgery and can follow the study's procedures. Participants will be randomly assigned to receive either the RxSight Light Adjustable Lens (LAL) or a standard monofocal lens. People with eye conditions like ectasia, dense cataracts that block macula examination, previous eye surgeries (except certain pterygium excisions), macular disease, uveitis, or ocular herpes simplex virus cannot join.

Inclusion Criteria

Willing and able to comply with the requirements for study specific procedures and visits

I am between 40 and 80 years old.

I agree to cataract surgery and to be randomly assigned an IOL type.

Exclusion Criteria

I have had herpes in my eye before.

I have had eye surgery, but if it was for pterygium, it did not extend more than 2mm onto the cornea.

Evidence of ectasia in either eye

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Light Adjustable Lens (LAL) and Light Delivery Device (LDD) or a monofocal control IOL

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Control IOL
• Light Adjustable lens (LAL)

Trial Overview The study aims to compare the safety outcomes of two types of intraocular lenses: the RxSight Light Adjustable Lens (LAL), which can be adjusted after implantation using a special light delivery device, and a standard monofocal control lens implanted during cataract surgery.

How Is the Trial Designed?

Group I: Light adjustable lens (LAL) and Light Delivery Device (LDD) Experimental Treatment 1 Intervention

Group II: Control IOL Active Control 1 Intervention

Who Is Running the Clinical Trial?

RxSight, Inc.

Lead Sponsor

Trials

8

Recruited

890+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637228/

Visual Outcomes of a Second-Generation, Enhanced UV ... To report on the visual outcomes of the second-generation (ActivShieldTM) Light Adjustable Lens (LAL) used in cataract surgery for patients ...

2. journals.lww.com journals.lww.com/jcrs/fulltext/2025/11000/clinical_data_registry_comparing_outcomes_of_two.3.aspx

Clinical data registry comparing outcomes of two light... Conclusions: Both LAL and LAL+ achieved excellent refractive and binocular visual outcomes at distance, intermediate, and near. The broadened DoF of the LAL+ ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11338023/

Clinical outcomes of the light-adjustable lens in eyes with a ... In this study, they found 96% were within ±0.50 D of target and 56% were 20/20 or better. These results also compare favorably with the accuracy ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160055B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Nonclinical laboratory studies performed demonstrate the safety and effectiveness of the. Light Adjustable Lens. These tests were performed in ...

5. journals.lww.com journals.lww.com/jcrs/abstract/9900/clinical_data_registry_comparing_outcomes_of_two.646.aspx

Clinical Data Registry Comparing Outcomes of Two Light... Both the LAL and LAL+ achieved excellent refractive and binocular visual outcomes at distance, intermediate and near.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9359783/

Visual Outcomes of an Enhanced UV Protected Light ... Phase 3 FDA study data showed those receiving the LAL had 92% accuracy within 0.50 D of target MRSE and were approximately twice as likely to ...

7. rxsight.com rxsight.com/healthcare-professionals/

Healthcare Professionals | Light Adjustable Lens from ... The Light Adjustable Lens from RxSight allows patients to test drive their vision after surgery so they can achieve the vision that's right for them.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03660865

NCT03660865 | Clinical Study to Evaluate the Safety and ... The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) ...