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Completed

NCT Number: NCT01346566

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

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.

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Key information

Conditions

Lens Subluxation Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380052, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subluxated Lenses
  • Traumatic or Non-traumatic etiology

Exclusion criteria

  • Dislocated Lenses

Treatment and study plan

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

Primary outcomes

  1. IOL Centration

    Time frame: 4 years follow-up

Secondary outcomes

  1. Complications

    Time frame: 4 years follow-up

  2. IOP

    Time frame: 4 years

  3. Posterior Capsule Opacification

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
May 3, 2011
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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