Clinical Outcomes of Patients with a Light Adjustable Lens (LAL) 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

Completed

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Key information

Conditions

IOL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

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

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, 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.

Primary outcomes

Patient Satisfaction - subjective questionnaire

Time frame: 3-18 months after cataract surgery

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

Bucci Laser Vision Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Aug 29, 2023
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