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

NCT06650358 | Enrolling By Invitation FDA Device

• 1 other identifier: IIT-004-02
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LAL+; Light Adjustable Lens+; Mix and match IOLs

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  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.

  3-18 months after phacoemulsification

Study Arms (1)

LAL+

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

Device: Light Adjustable Lens+

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.

LAL+

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PI's current patients

You may qualify if:

• 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

You may not qualify if:

• Visually significant eye disease

Sponsors & Collaborators

• Frank A. Bucci, Jr., M.D.: lead

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Intraocular Lymphoma; Cataract

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Eye Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: October 16, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)