Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487897
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Phase III Presbyopia Correction Using the VIS Opti-K System
Sponsor:
VIS Inc
Organization:
VIS Inc
Study Overview
Official Title:
Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty Opti-K System Phase IIIa
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Opti-K
Brief Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic emmetropic and low hyperopic presbyope subjects The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None