Status:
COMPLETED
Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study
Lead Sponsor:
Vienna Institute for Research in Ocular Surgery
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard I...
Detailed Description
Although there may be no direct benefit to the subjects under study, the investigation will assess the stability which determines the efficacy for future toric optics and the amount of glistening and ...
Eligibility Criteria
Inclusion
- Age-related cataract
- Age 21 and older
- Visual Acuity \> 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Exclusion
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
- Previous ocular surgery or trauma.
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04329754
Start Date
April 1 2012
End Date
February 1 2015
Last Update
October 17 2022
Active Locations (1)
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1
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, Austria, 1140