Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes

September 26, 2012 updated by: Michael Koss, Johann Wolfgang Goethe University Hospital

Intraocular Architecture of Secondary Implanted Anterior Chamber Iris-Fixated Lenses in Aphakic Eyes Evaluated With Anterior Segment Optical Coherence Tomography

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

Study Overview

Status

Completed

Conditions

Detailed Description

18 eyes of 16 patients received secondary anteriorly iris-fixated intraocular lenses (IOLs) to correct for aphakia without capsular support, partly combined with anterior or complete pars plana vitrectomy. Primary outcome measurements included visual acuity (6m Snellen charts), central endothelium cell count (cECC) and postoperative intraocular position of the IOL assessed with anterior segment optical coherence tomography (OCT).

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Zentrum für Augenheilkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 84 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular IOL position
Time Frame: 12-35 months postoperatively
12-35 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (ESTIMATE)

October 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2012

Last Update Submitted That Met QC Criteria

September 26, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK-APHAKIA-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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