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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346566
First Posted: May 3, 2011
Last Update Posted: May 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Iladevi Cataract and IOL Research Center
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • IOL Centration [ Time Frame: 4 years follow-up ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 4 years follow-up ]
  • IOP [ Time Frame: 4 years ]
  • Posterior Capsule Opacification [ Time Frame: 4 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subluxated Lenses
  • Traumatic or Non-traumatic etiology

Exclusion Criteria:

  • Dislocated Lenses
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 30, 2011
First Posted: May 3, 2011
Last Update Posted: May 19, 2011
Last Verified: May 2011

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