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

NCT06016231 | Completed FDA Device

• 1 other identifier: IIT-004
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IOL

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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, 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.

LAL in at least one eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

You may not qualify if:

• Visually significant eye disease

Sponsors & Collaborators

• Bucci Laser Vision Institute: lead

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Study Officials

• Frank A Bucci, MD

  Bucci Laser Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 29, 2023
• Study Start: August 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 21, 2024

Record last verified: 2023-08

Locations

US (1)