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

NCT ID: NCT01346566

Last Updated: 2011-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Lens Subluxation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cionni Modified Capsule Tension Ring

Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subluxated Lenses
* Traumatic or Non-traumatic etiology

Exclusion Criteria

* Dislocated Lenses
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role lead

Responsible Party

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Iladevi Cataract and IOL Research Centre

Principal Investigators

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Abhay R Vasavada, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

Iladevi Cataract & IOL Research Centre

Locations

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Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 22317913 (View on PubMed)

Other Identifiers

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ICIRCcionni

Identifier Type: -

Identifier Source: org_study_id

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