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

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

IOL, Cataract Cataract Eye Diseases Eye Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intraocular Lymphoma Lens Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults with bilateral pseudophakia who have been implanted with the LAL+ in at least one eye and who have completed LDD light treatments
Sign a written Informed Consent Form

Exclusion criteria

Visually significant eye disease

Treatment and study plan

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.

Primary outcomes

Patient Satisfaction

Time frame: 3-18 months after phacoemulsification

Description: Subjective questionnaire explores the frequency/need for glasses for various visual functions at distance/intermediate/near, experience with dysphotopsias, and overall satisfaction of visual function without glasses.

Sponsors and collaborators

Lead sponsor

Frank A. Bucci, Jr., M.D.

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 21, 2024
Registry last updated: Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed