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

Lens Subluxation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790268
• Other study ID #: ICIRC-UBM
• Status: Completed
• Phase: N/A
• First received: May 24, 2016
• Last updated: June 2, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lens Subluxation

Intervention

Procedure:
• Lens Subluxation Surgery
Surgical Intervention to include Cionni Ring implantation and in-the-bag IOL implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Biomicroscopic Measurement of Anterior Chamber Depth, Cionni Ring Position, distance from the posterior surface of iris and ciliary body region	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	6 months postoperative	No