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OpenTrials
Completed

NCT Number: NCT02790268

Ultrasound Biomicroscopic Analysis of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses

To report the Ultrasound Biomicroscopic findings following Cionni Ring bag fixation and in-the-bag IOL Implantation. To assess the relationship of the Bag and Cionni ring positioning in relation to surrounding ocular structures, in pediatric eyes

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

Cionni ring fixation of the capsular bag in conjunction with placement of an IOL has been found to be safe and effective compared with other current alternatives, even given the exceptionally high difficulty levels and complexity of these cases, in both adult and pediatric eyes. One limitation of techniques requiring trans-scleral suturing is that the suture cannot always be passed under adequate visualization, and, once the knot is secured, the exact position of the Cionni ring cannot always be accurately localized. Analysis of Cionni ring position with respect to the IOL and iris is important, as faulty placement of the ring or IOL can lead to complications which can threaten vision, especially in children with a high predisposition towards postoperative adverse events. Unfortunately, pupillary dilatation and slit-lamp examination may not always be adequate to assess the Cionni ring or the eyelet position, as it occupies the peripheral section of the capsular bag. UBM has been shown to be accurate and reproducible in examining the haptic position in relation to the sulcus and ciliary body, anterior chamber depth (ACD), vitreous incarceration, focal iris abnormalities, angle anatomy, and relationship of the iris to the lens (straight or tilted). This study aims to provide information on UBM findings following Cionni ring implantation in pediatric eyes for non-traumatic subluxation of the crystalline lens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children less than 18 years of age,
  • Non-traumatic Lens Subluxation undergoing Cionni RIng Bag fixation with In-the-Bag IOL implantation

Exclusion criteria

  • Traumatic Lens Subluxation
  • Intraoperative inability to fixate the Cionni Ring

Treatment and study plan

Lens Subluxation Surgery

Procedure

Surgical Intervention to include Cionni Ring implantation and in-the-bag IOL implantation

Primary outcomes

  1. Ultrasound Biomicroscopic Measurement of Anterior Chamber Depth, Cionni Ring Position, distance from the posterior surface of iris and ciliary body region

    Time frame: 6 months postoperative

    To Measure in millimeters, the anterior chamber depth, the distance of cionni ring from posterior surface of iris, the distance of cionni ring from the ciliary body region

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2016
Registry last updated
Jun 3, 2016

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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