Viewing Study NCT01346566


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Study NCT ID: NCT01346566
Status: COMPLETED
Last Update Posted: 2011-05-19
First Post: 2011-04-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Sponsor: Iladevi Cataract and IOL Research Center
Organization:

Study Overview

Official Title: Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series
Status: COMPLETED
Status Verified Date: 2011-05
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 report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses.
Detailed Description: The introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag IOL implantation. The Cionni modified capsule tension ring (M-CTR) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. Adult and pediatric studies have shown the usefulness of the M-CTR to manage zonular weakness. However, there are very few prospective studies that show the outcomes following implantation of the M-CTR and in-the-bag IOL on a longterm basis. Therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following M-CTR and in-the-bag intraocular lens (IOL) implantation.

Study Oversight

Has Oversight DMC: True
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?: