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Clinical Outcomes of Patients with LAL+ in At Least One Eye

NCT06650358 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-10-21

No results posted yet for this study

Summary

The objective of this study is to collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens+ (LAL+) in at least one eye

Conditions

  • IOL, Cataract

Interventions

DEVICE

Light Adjustable Lens+

The Light Adjustable Lens+ (LAL+) is a posterior chamber, UV absorbing, three-piece, foldable, photo reactive silicone intraocular lens with a squared-posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure to the implanted LAL+ using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change postoperatively. A subsequent lock-in exposure is delivered to the implanted LAL+ to stabilize the lens power. The LAL+ has a modified aspheric anterior surface that creates a small continuous increase in central lens power, which is designed to slightly extend the depth of focus.

Sponsors & Collaborators

  • Frank A. Bucci, Jr., M.D.

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-01-01
Completion
2025-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650358 on ClinicalTrials.gov