Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863247
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-19
First Post:
2023-05-09
Brief Title:
Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
Sponsor:
Hospital dos LusÃadas
Organization:
Hospital dos LusÃadas
Study Overview
Official Title:
Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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 purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP Carl Zeiss Meditec AG implantation to achieve satisfactory post-post-operativly spectacle-free vision Social biometric and patient reported outcomes will be evaluated
Detailed Description:
Pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including corneal topography and aberrometry Pentacam biometry IOLMaster 700 Carl Zeiss Meditec AG Jena Germany specular microscopy CEM 539 Nidek Co Ltd and macular and papillary Optical Coherence Tomography Cirrus 4000 Hd OCT Carl Zeiss Meditec AG
All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement Patients had both eyes operated within a week
Patients were assessed at day 1 6 and month 3 after surgery Six months post-operatively refraction and slit-lamp examination was performed and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction spectacle independence and dysphoptsia like-symptoms
All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement Patients had both eyes operated within a week
Patients were assessed at day 1 6 and month 3 after surgery Six months post-operatively refraction and slit-lamp examination was performed and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction spectacle independence and dysphoptsia like-symptoms
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None