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Clinical Trials/NCT01346566
NCT01346566CompletedPhase 3

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

Iladevi Cataract and IOL Research Center2 sites in 1 country33 target enrollmentStarted: January 1, 2003Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
33
Locations
2
Primary Endpoint
IOL Centration

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subluxated Lenses
  • Traumatic or Non-traumatic etiology

Exclusion Criteria

  • Dislocated Lenses

Outcomes

Primary Outcomes

IOL Centration

Time Frame: 4 years follow-up

Secondary Outcomes

  • Complications(4 years follow-up)
  • IOP(4 years)
  • Posterior Capsule Opacification(4 years)

Investigators

Sponsor
Iladevi Cataract and IOL Research Center
Sponsor Class
Other

Study Sites (2)

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