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NCT00773266 Clinical Trial

Intraocular Position of Secondary Iris-Fixated IOLs in Aphakic Eyes

Aphakia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00773266
Other study ID # MK-APHAKIA-08
Secondary ID
Status Completed
Phase N/A
First received October 15, 2008
Last updated September 26, 2012
Start date September 2006
Est. completion date June 2008

Study information
Verified date September 2012
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 84 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Zentrum für Augenheilkunde Frankfurt Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular IOL position 12-35 months postoperatively No
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