Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses

Lens Subluxation Clinical Trial

Official title:

Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346566
• Other study ID #: ICIRCcionni
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2011
• Last updated: May 18, 2011
• Start date: January 2003
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subluxated Lenses

• Traumatic or Non-traumatic etiology

Exclusion Criteria:

• Dislocated Lenses

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lens Subluxation

Intervention

Device:
• Cionni Modified Capsule Tension Ring
Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag

Locations

Country	Name	City	State
India	Iladevi Cataract & IOL Research Centre	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOL Centration		4 years follow-up	No
Secondary	Complications		4 years follow-up	Yes
Secondary	IOP		4 years	Yes
Secondary	Posterior Capsule Opacification		4 years	No