NCT01346566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

7.9 years

First QC Date

April 30, 2011

Last Update Submit

May 18, 2011

Conditions

Lens Subluxation

Keywords

Cionni RingIn-the-bag IOLSubluxated lensesIntraoperative PerformancePostoperative Outcome

Outcome Measures

Primary Outcomes (1)

  • IOL Centration

    4 years follow-up

Secondary Outcomes (3)

  • Complications

    4 years follow-up

  • IOP

    4 years

  • Posterior Capsule Opacification

    4 years

Interventions

Cionni Modified Capsule Tension RingDEVICE

Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subluxated Lenses
  • Traumatic or Non-traumatic etiology

You may not qualify if:

  • Dislocated Lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380052, India

Location

Related Publications (1)

  • Vasavada AR, Praveen MR, Vasavada VA, Yeh RY, Srivastava S, Koul A, Trivedi RH. Cionni ring and in-the-bag intraocular lens implantation for subluxated lenses: a prospective case series. Am J Ophthalmol. 2012 Jun;153(6):1144-53.e1. doi: 10.1016/j.ajo.2011.11.012. Epub 2012 Feb 7.

    PMID: 22317913DERIVED

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Abhay R Vasavada, MS, FRCS

    Iladevi Cataract & IOL Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2011

First Posted

May 3, 2011

Study Start

January 1, 2003

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

IN(1)