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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014