Trials / Completed
CompletedNCT03660865
Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- RxSight, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Light Adjustable lens (LAL) and Light Delivery Device (LDD) | Primary eye will receive Light adjustable lens with Light delivery Device treatments |
| DEVICE | Control IOL | Fellow eye will receive control IOL |
Timeline
- Start date
- 2018-08-28
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2018-09-07
- Last updated
- 2021-12-23
- Results posted
- 2021-11-22
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03660865. Inclusion in this directory is not an endorsement.