Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes - Full Text View

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00773266

Purpose

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

Condition
Aphakia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Locations

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

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

More Information

Responsible Party:	Zentrum für Augenheilkunde, JWG University Hospitals ( Michael J Koss, MD )
Study ID Numbers:	MK-APHAKIA-08
Study First Received:	October 15, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00773266
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

Study placed in the following topic categories:

Eye Diseases
Aphakia
Neoplasm Metastasis
Lens Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009