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

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01346566
First received: April 30, 2011
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Lens Subluxation
 Device: Cionni Modified Capsule Tension Ring
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • IOL Centration [ Time Frame: 4 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 4 years follow-up ] [ Designated as safety issue: Yes ]
  • IOP [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Posterior Capsule Opacification [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: January 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subluxated Lenses
  • Traumatic or Non-traumatic etiology

Exclusion Criteria:

  • Dislocated Lenses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346566

Locations
India
Iladevi Cataract & IOL Research Centre
Ahmedabad, Gujarat, India, 380052
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Abhay R Vasavada, MS, FRCS Iladevi Cataract & IOL Research Centre
  More Information

No publications provided by Iladevi Cataract and IOL Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Abhay R. Vasavada, Iladevi Cataract and IOL Research Centre
ClinicalTrials.gov Identifier: NCT01346566     History of Changes
Other Study ID Numbers: ICIRCcionni
Study First Received: April 30, 2011
Last Updated: May 18, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Iladevi Cataract and IOL Research Center:
Cionni Ring
In-the-bag IOL
Subluxated lenses
Intraoperative Performance
Postoperative Outcome

Additional relevant MeSH terms:
Lens Subluxation
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013