Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578884
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-10
Brief Title:
A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medicontur preloaded hydrophobic monofocal toric intraocular lenses IOLs are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power
The investigation will be performed as a prospective non-comparative single arm study with a single center design Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025
Data from six visits will be collected
Visit 1 Screening and Baseline up to 90 days prior to the surgery
Visit 2 IOL implantation Day 0
Visit 3 Day 1 post-operatively - 0 day
Visit 4 Day 7 post-operatively - 3 days
Visit 5 Month 1 post-operatively - 2 weeks
Visit 6 Month 6 post-operatively - 1 month
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power
The investigation will be performed as a prospective non-comparative single arm study with a single center design Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025
Data from six visits will be collected
Visit 1 Screening and Baseline up to 90 days prior to the surgery
Visit 2 IOL implantation Day 0
Visit 3 Day 1 post-operatively - 0 day
Visit 4 Day 7 post-operatively - 3 days
Visit 5 Month 1 post-operatively - 2 weeks
Visit 6 Month 6 post-operatively - 1 month
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None