Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses

• Sponsor: Iladevi Cataract and IOL Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01346566
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Duration (Months): 95
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lens Subluxation	Device: Cionni Modified Capsule Tension Ring	Phase 3

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
• Actual Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

1. IOL Centration [4 years follow-up]

Secondary Outcome Measures

1. Complications [4 years follow-up]

2. IOP [4 years]

3. Posterior Capsule Opacification [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subluxated Lenses

• Traumatic or Non-traumatic etiology

Exclusion Criteria:

• Dislocated Lenses

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iladevi Cataract & IOL Research Centre	Ahmedabad	Gujarat	India	380052

Sponsors and Collaborators

• Iladevi Cataract and IOL Research Center

Investigators

• Principal Investigator: Abhay R Vasavada, MS, FRCS, Iladevi Cataract & IOL Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01346566
• Other Study ID Numbers: ICIRCcionni
• First Posted: May 3, 2011
• Last Update Posted: May 19, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: Cionni Ring; In-the-bag IOL; Subluxated lenses; Intraoperative Performance; Postoperative Outcome
• Additional relevant MeSH terms: Lens Subluxation

Study Results

No Results Posted as of May 19, 2011