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

Conditions

• IOL, Cataract

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Light Adjustable Lens+ — DEVICE
  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.

Study Details

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

Key Dates

Start date

Oct 16, 2024

Status verified

Oct 2024

Primary completion

Jan 1, 2025

Completion

Feb 1, 2025

Study Design

Enrollment

25 participants (estimated)

Arms

• Arm: LAL+
  Bilateral pesudophakic adults implanted with the LAL+ in at least one eye

Primary Outcome Measure

Patient Satisfaction [ Time Frame: 3-18 months after phacoemulsification ]

Locations (1)

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