NCT03729024

Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

A Single Center Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: RxSight, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

Conditions

• Aphakia
• Cataract

Interventions

Type	Name	Description
DEVICE	Light Adjustable lens (LAL) and Light Delivery Device (LDD)	Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Timeline

• Start date: 2018-01-26
• Primary completion: 2019-04-15
• Completion: 2020-02-04
• First posted: 2018-11-02
• Last updated: 2021-08-06
• Results posted: 2021-05-19

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated device study