Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00773266
First received: October 15, 2008
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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


Condition
Aphakia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intraocular Architecture of Secondary Implanted Anterior Chamber Iris-Fixated Lenses in Aphakic Eyes Evaluated With Anterior Segment Optical Coherence Tomography

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Intraocular IOL position [ Time Frame: 12-35 months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   16 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00773266

Locations
Germany
Zentrum für Augenheilkunde
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00773266     History of Changes
Other Study ID Numbers: MK-APHAKIA-08
Study First Received: October 15, 2008
Last Updated: September 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Aphakia
Secondary IOL-Implantation
Iris-Fixated IOL
Artisan
Anterior Segment OCT
Aphakia - secondary iris-fixated IOL position

Additional relevant MeSH terms:
Aphakia
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 01, 2014