Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT03895034
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2019-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Sponsor:
RxSight, Inc.
Organization:
Study Overview
Official Title:
A Single Center Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: