Clinical Outcomes of Patients With a Light Adjustable Lens (LAL) in at Least One Eye

IOL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06016231
• Other study ID #: IIT-004
• Status: Enrolling by invitation
• Start date: August 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Bucci Laser Vision Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IOL

Intervention

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.

Locations

Country	Name	City	State
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bucci Laser Vision Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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