Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-03 @ 9:38 PM
Study NCT ID:
NCT03326869
Status:
TERMINATED
Last Update Posted:
2020-08-10
First Post:
2017-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets
Sponsor:
Eye Center of North Florida
Organization:
Study Overview
Official Title:
A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets With a Delayed or Non-Delayed Approach
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corneal Inlay supplier no longer in business
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 the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted in corneal pockets with a delayed or a non-delayed approach.
Detailed Description:
Patients must be presbyopic with a reading add from +1.5 to +2.5 D, and both emmetropes (MRSE from -0.5 to +0.5 D) as well as ametropes (requiring concurrent LASIK) are included in the investigation. In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day. In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: