Posterior Capsule Opacification Development With Two Different Intraocular Lenses
NCT ID: NCT01734343
Last Updated: 2012-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2009-01-31
2012-06-30
Brief Summary
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The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.
The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.
Modifications in IOL design and material lead to a decrease in the incidence of PCO.
During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.
The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 3 years.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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HOYA iMics Y-60H
eyes with implanted intraocular lens HOYA iMics Y-60H
HOYA iMics Y-60H
same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
PhysIOL microAY
eyes with implanted intraocular lens PhysIOL microAY
PhysIOL microAY
same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye
Interventions
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HOYA iMics Y-60H
same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
PhysIOL microAY
same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye
Eligibility Criteria
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Inclusion Criteria
* good overall physical constitution
Exclusion Criteria
* intraocular complication like posterior capsular tear
* glaucoma
* uveitis
* corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
30 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Rupert Menapace
Ao.Univ.-Prof. Dr.med.univ.
Principal Investigators
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Rupert Menapace, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Department of Ophthalmology and Optometry of the Medical University Vienna
Vienna, Vienna, Austria
Countries
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Other Identifiers
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EK Nr:847/2010
Identifier Type: -
Identifier Source: org_study_id