What side effects are associated with this type of intervention?

Common treatments for cataracts, such as cataract surgery with intraocular lens (IOL) implantation, can have side effects including infection, inflammation, bleeding, swelling, retinal detachment, and increased intraocular pressure. For treatments like the Light Adjustable Lens (LAL), which is adjusted post-implantation using UV light, additional potential side effects may include UV light-related damage, phototoxicity, and an increased risk of infection or inflammation due to multiple adjustments.

What prior FDA approvals exist?

The FDA has approved various intraocular lenses (IOLs) for the treatment of cataracts, including monofocal, multifocal, and toric lenses. The Light Adjustable Lens (LAL) by RxSight is a notable advancement, as it allows for post-implantation adjustments using UV light to fine-tune vision correction. This technology provides a customizable solution for patients, enhancing visual outcomes after cataract surgery. Other FDA-approved treatments focus on the initial implantation of fixed-power IOLs without the capability for post-surgical adjustments.

What other types of research exist?

Promising alternatives to Light Adjustable Lens (LAL) for cataract patients include: 1) Extended Depth of Focus (EDOF) IOLs, which provide a continuous range of vision and reduce dependence on glasses. 2) Multifocal IOLs, which offer multiple focal points to improve near, intermediate, and distance vision. 3) Trifocal IOLs, which enhance vision at three different distances, providing a broader range of clear vision. 4) Accommodating IOLs, which mimic the eye's natural focusing ability, allowing for better dynamic vision. These options are gaining traction due to their ability to improve visual outcomes and patient satisfaction.

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Intraocular Lens

LAL + LDD for Cataracts

N/A

Waitlist Available

Research Sponsored by RxSight, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed

Be older than 18 years old

Must not have

History of ocular herpes simplex virus in either eye

Patients with sufficiently dense cataracts that preclude examination of the macula in either eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects were not specified in the provided information. However, common risks associated with intraocular lenses include inflammation, infection risk post-surgery, visual disturbances such as glare and halos around lights, and potential need for additional procedures if adjustments are required.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had herpes in my eye before.

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My cataracts are dense enough to block a clear view of my macula.

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I am taking medication that could harm my eyesight, like tamoxifen.

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I have had uveitis in one or both of my eyes.

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I have a pre-existing condition affecting the central part of my eye's retina.

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I am on medication that makes my skin more sensitive to sunlight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Light adjustable lens (LAL) and Light Delivery Device (LDD)Experimental Treatment1 Intervention

Group II: Control IOLActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Light Adjustable lens (LAL) and Light Delivery Device (LDD)

2018

N/A

~200

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cataract treatment primarily involves the surgical removal of the cloudy natural lens and its replacement with an intraocular lens (IOL). The Light Adjustable Lens (LAL) is a novel type of IOL that allows for post-implantation adjustments using UV light, enabling precise customization of vision correction after surgery. This mechanism is significant for cataract patients as it offers the potential for improved visual outcomes and reduced dependence on glasses, addressing individual visual needs more accurately than traditional IOLs.