Posterior Capsule Opacification Development With Two Different Intraocular Lenses (MIPHY)
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|ClinicalTrials.gov Identifier: NCT01734343|
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
Age-related cataract is the main cause of impaired vision in the elderly population worldwide.
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.
|Condition or disease||Intervention/treatment||Phase|
|Posterior Capsule Opacification Cataract||Device: HOYA iMics Y-60H Device: PhysIOL microAY||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
HOYA iMics Y-60H
eyes with implanted intraocular lens HOYA iMics Y-60H
Device: HOYA iMics Y-60H
same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
eyes with implanted intraocular lens PhysIOL microAY
Device: PhysIOL microAY
same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye
- posterior capsular opacification (PCO) [ Time Frame: 3 years ]subjective and objective PCO scoring
- best corrected visual acuity (BCVA) [ Time Frame: 3 years ]
- Nd:YAG rate [ Time Frame: 3 years ]
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): NCT01734343
|Department of Ophthalmology and Optometry of the Medical University Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Rupert Menapace, Prof. Dr.||Medical University of Vienna|