Prospective Study of Cionni Ring and In-the-bag IOL Impla... | NCT01346566

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

NCT01346566

Sponsor

Iladevi Cataract and IOL Research Center

Status

Completed

Last Update Posted

May 19, 2011Estimated

Enrollment

33Actual

Phase

Phase 3

Conditions

Lens Subluxation

Interventions

Cionni Modified Capsule Tension Ring

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 30, 2011

First Submission Date that Met QC Criteria

May 2, 2011

First Posted Date

May 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2011

Last Update Posted Date

May 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cionni Modified Capsule Tension Ring	Device	Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOL Centration		4 years follow-up

Secondary Outcomes

Measure	Description	Time Frame
Complications		4 years follow-up
IOP		4 years
Posterior Capsule Opacification

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subluxated Lenses
Traumatic or Non-traumatic etiology

Exclusion Criteria:

Dislocated Lenses

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abhay R Vasavada, MS, FRCS	Iladevi Cataract & IOL Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Iladevi Cataract & IOL Research Centre		Ahmedabad	Gujarat	380052	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22317913	Derived	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.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases