Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04072978
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2019-08-26
Brief Title:
Anterior Chamber Versus Scleral Fixated Intraocular Lens Long-term Vision and Safety Outcomes
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Anterior Chamber Versus Scleral Fixated Intraocular Lens Long-term Vision and Safety Outcomes
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes safety and stability of anterior chamber intraocular lenses AC IOLs vs scleral-fixated intraocular lenses SF IOLs
Detailed Description:
On the pre-operative visit specular microscopy biometry applanation tonometry and ocular coherence tomography OCT will be performed The patient will then undergo treatment as per surgeons discussion decision with the patient for implantation of an AC-IOL or SF-IOL Participation in the study will not impact the management plan in any way Specular microscopy will be performed wit the CellChek XL Konan Medical Irvine CA Biometry will be performed with the IOLMASTER Carl Ziess Meditec Jena Germany and anterior segment and macular OCT will be performed with the Cirrus-HD OCT Carl Zeiss Metidec Jena Germany EC count OCT macula and anterior segment and specular microscopy will be performed at baseline week 1 month 1 month 6 12 and 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None