NCT02790268

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

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, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

May 24, 2016

Last Update Submit

June 2, 2016

Conditions

Lens Subluxation

Keywords

Cionni RingUltrasound Biomicroscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lens Subluxation

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

Procedure: Lens Subluxation Surgery

Interventions

Lens Subluxation SurgeryPROCEDURE

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

Lens Subluxation

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing Cionni Ring Implantation with in-the-bag implantation for subluxated lenses

You may qualify if:

  • Children less than 18 years of age,
  • Non-traumatic Lens Subluxation undergoing Cionni RIng Bag fixation with In-the-Bag IOL implantation

You may not qualify if:

  • Traumatic Lens Subluxation
  • Intraoperative inability to fixate the Cionni Ring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Abhay Vasavada, MS,FRCS

    Iladevi Cataract & IOL Research Centre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Iladevi Cataract and IOL Research Center

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 3, 2016

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share