Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 4:43 PM
Study NCT ID:
NCT02790268
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Biomicroscopic Analysis of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Sponsor:
Iladevi Cataract and IOL Research Center
Organization:
Study Overview
Official Title:
Ultrasound Biomicroscopic Analysis of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Status:
COMPLETED
Status Verified Date:
2016-05
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:
To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring positioning in relation to surrounding ocular structures, in pediatric eyes
Detailed Description:
Cionni ring fixation of the capsular bag in conjunction with placement of an IOL has been found to be safe and effective compared with other current alternatives, even given the exceptionally high difficulty levels and complexity of these cases, in both adult and pediatric eyes. One limitation of techniques requiring trans-scleral suturing is that the suture cannot always be passed under adequate visualization, and, once the knot is secured, the exact position of the Cionni ring cannot always be accurately localized. Analysis of Cionni ring position with respect to the IOL and iris is important, as faulty placement of the ring or IOL can lead to complications which can threaten vision, especially in children with a high predisposition towards postoperative adverse events. Unfortunately, pupillary dilatation and slit-lamp examination may not always be adequate to assess the Cionni ring or the eyelet position, as it occupies the peripheral section of the capsular bag. UBM has been shown to be accurate and reproducible in examining the haptic position in relation to the sulcus and ciliary body, anterior chamber depth (ACD), vitreous incarceration, focal iris abnormalities, angle anatomy, and relationship of the iris to the lens (straight or tilted). This study aims to provide information on UBM findings following Cionni ring implantation in pediatric eyes for non-traumatic subluxation of the crystalline lens.
Study Oversight
Has Oversight DMC:
False
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?: