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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02790268
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center

Brief Summary:
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

Condition or disease Intervention/treatment
Lens Subluxation Procedure: Lens Subluxation Surgery

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Ultrasound Biomicroscopic Analysis of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Lens Subluxation
Pediatric eyes with lens subluxation undergoing Cionni Ring Bag fixation with in-the-bag IOL Implantation
Procedure: Lens Subluxation Surgery
Surgical Intervention to include Cionni Ring implantation and in-the-bag IOL implantation

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing Cionni Ring Implantation with in-the-bag implantation for subluxated lenses

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02790268

Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
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Study Director: Abhay Vasavada, MS,FRCS Iladevi Cataract & IOL Research Centre
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Responsible Party: Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center, Iladevi Cataract and IOL Research Center Identifier: NCT02790268    
Other Study ID Numbers: ICIRC-UBM
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abhay R. Vasavada, Iladevi Cataract and IOL Research Center:
Cionni Ring
Ultrasound Biomicroscopy
Additional relevant MeSH terms:
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Lens Subluxation
Lens Diseases
Eye Diseases