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

NCT ID: NCT02790268

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-06-30

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

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.

Conditions

Lens Subluxation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Lens Subluxation

Pediatric eyes with lens subluxation undergoing Cionni Ring Bag fixation with in-the-bag IOL Implantation

Lens Subluxation Surgery

Intervention Type: PROCEDURE

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

Interventions

Lens Subluxation Surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role: lead

Responsible Party

Abhay R. Vasavada

Director, Iladevi Cataract and IOL Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abhay Vasavada, MS,FRCS

Role: STUDY_DIRECTOR

Iladevi Cataract & IOL Research Centre

Other Identifiers

ICIRC-UBM

Identifier Type: -

Identifier Source: org_study_id