NCT00773266

Brief Summary

The purpose of this study is to evaluate the intraocular stability and safety of secondary iris-fixated IOLs in aphakic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

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

September 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

October 15, 2008

Last Update Submit

September 26, 2012

Conditions

Aphakia

Keywords

AphakiaSecondary IOL-ImplantationIris-Fixated IOLArtisanAnterior Segment OCTAphakia - secondary iris-fixated IOL position

Outcome Measures

Primary Outcomes (1)

  • Intraocular IOL position

    12-35 months postoperatively

Eligibility Criteria

Age16 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with long standing Aphakia and eligibility for secondary IOL implantantion were retrospectively examined

You may qualify if:

  • Patients with aphakia due to complicated cataract surgery, weakness in lens support (capsula, zonulae) Marfans´s syndrome

You may not qualify if:

  • Aphakia due to preexisting corneal, retinal o uveal disease, low endothelial cell count

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentrum für Augenheilkunde

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Aphakia

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

DE(1)