Clinical Outcomes of Patients with a Light Adjustable Lens (LAL) in At Least One Eye

Clinial Outcomes of Bilateral Pseudophakic Patients with a Light Adjustable Lens (LAL) Implanted in At Least One Eye

To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye

Study Overview

• Status: Completed
• Conditions: IOL
• Intervention / Treatment: Device: Light Adjustable Lens

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Bilateral pseudophakia in adults implanted with the LAL in at least one eye and who have completed Light Delivery Device (LDD) light treatments

Description

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

Exclusion Criteria:

• Visually significant eye disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

LAL in at least one eye

Device: Light Adjustable Lens; The Light Adjustable Lens (LAL) is a posterior chamber, UV absorbing, three-piece, foldable, photoreactive silicone intraocular lens with a squared posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure of the implanted RxSight 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 post-operatively. A subsequent lock-in exposure is delivered to the implanted LAL to stabilize the lens power.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction - subjective questionnaire	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 cataract surgery

Collaborators and Investigators

• Sponsor: Bucci Laser Vision Institute
• Investigators: Principal Investigator: Frank A Bucci, MD, Bucci Laser Vision Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IIT-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No