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Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes

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ClinicalTrials.gov Identifier: NCT00773266
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospital

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

Condition or disease
Aphakia

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
Actual Enrollment : 16 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008



Primary Outcome Measures :
  1. Intraocular IOL position [ Time Frame: 12-35 months postoperatively ]


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Ages Eligible for Study:   16 Years to 84 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773266


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

Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT00773266     History of Changes
Other Study ID Numbers: MK-APHAKIA-08
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Aphakia
Neoplastic Processes
Neoplasms
Pathologic Processes
Lens Diseases
Eye Diseases