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

Primary Purpose

Lens Subluxation

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Cionni Modified Capsule Tension Ring
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lens Subluxation focused on measuring Cionni Ring, In-the-bag IOL, Subluxated lenses, Intraoperative Performance, Postoperative Outcome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subluxated Lenses
  • Traumatic or Non-traumatic etiology

Exclusion Criteria:

  • Dislocated Lenses

Sites / Locations

  • Iladevi Cataract & IOL Research Centre

Outcomes

Primary Outcome Measures

IOL Centration

Secondary Outcome Measures

Complications
IOP
Posterior Capsule Opacification

Full Information

First Posted
April 30, 2011
Last Updated
May 18, 2011
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01346566
Brief Title
Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Official Title
Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lens Subluxation
Keywords
Cionni Ring, In-the-bag IOL, Subluxated lenses, Intraoperative Performance, Postoperative Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cionni Modified Capsule Tension Ring
Intervention Description
Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag
Primary Outcome Measure Information:
Title
IOL Centration
Time Frame
4 years follow-up
Secondary Outcome Measure Information:
Title
Complications
Time Frame
4 years follow-up
Title
IOP
Time Frame
4 years
Title
Posterior Capsule Opacification
Time Frame
4 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subluxated Lenses Traumatic or Non-traumatic etiology Exclusion Criteria: Dislocated Lenses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhay R Vasavada, MS, FRCS
Organizational Affiliation
Iladevi Cataract & IOL Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Centre
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
22317913
Citation
Vasavada AR, Praveen MR, Vasavada VA, Yeh RY, Srivastava S, Koul A, Trivedi RH. Cionni ring and in-the-bag intraocular lens implantation for subluxated lenses: a prospective case series. Am J Ophthalmol. 2012 Jun;153(6):1144-53.e1. doi: 10.1016/j.ajo.2011.11.012. Epub 2012 Feb 7.
Results Reference
derived

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

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