NCT06650358

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

CLINICAL OUTCOMES of BILATERAL PSEUDOPHAKIC PATIENTS with a LIGHT ADJUSTABLE LENS+ (LAL)+ IMPLANTED in AT LEAST ONE EYE

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Frank A. Bucci, Jr., M.D. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

A retrospective-prospective, single-center study will be conducted. Patient charts will be retrospectively reviewed to collect data from the patient's comprehensive preoperative exam. Subjects will attend one stud visit post final LDD light treatment.

Conditions

• IOL, Cataract

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2024-10-21
• Last updated: 2024-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study