LAL + LDD for Cataracts

Recruiting at 14 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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares the safety of a special adjustable lens with a standard lens in patients needing lens implants, usually after cataract surgery. The special adjustable lens can be fine-tuned using light after it is placed in the eye to improve vision. These lenses are a relatively new option for cataract surgery that allows for adjustments after surgery using UV light.

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.

What data supports the effectiveness of the treatment Light Adjustable Lens (LAL) for cataracts?

Research shows that Light Adjustable Lenses (LALs) can improve vision after cataract surgery by allowing adjustments to correct vision issues like astigmatism (a condition where the eye does not focus light evenly) and myopia (nearsightedness). This flexibility helps achieve better visual outcomes for patients. ^{1 2 3 4 5}

Is the Light Adjustable Lens (LAL) safe for use in humans?

The Light Adjustable Lens (LAL) has been studied for its safety in cataract surgery, with long-term follow-up studies showing it is generally safe for use in humans. ^{1 2 3 6 7}

How is the Light Adjustable Lens (LAL) treatment for cataracts different from other treatments?

The Light Adjustable Lens (LAL) is unique because it allows for post-surgery adjustments to the lens using light, enabling precise vision correction tailored to the patient's needs after cataract surgery. This is different from traditional lenses, which do not offer this level of customization after implantation. ^{1 2 3 4 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Light adjustable intraocular lenses: an updated platform for cataract surgery. [2022]

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

Use of the light-adjustable lens to correct astigmatism after cataract surgery. [2019]

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

Light adjustable intraocular lenses in cataract surgery: considerations. [2023]

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

Initial results of Descemet's membrane endothelial keratoplasty combined with cataract surgery and implantation of the light adjustable lens. [2023]

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

Correction of myopia after cataract surgery with a light-adjustable lens. [2009]

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

Long-term follow-up and clinical evaluation of the light-adjustable intraocular lens implanted after cataract removal: 7-year results. [2021]

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

Comparing Visual Outcomes of Light Adjustable Intraocular Lenses in Patients With and Without Prior History of Corneal Refractive Surgery. [2023]

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

A light adjustable lens with injectable optics. [2007]