Clinical Trial: Posterior Capsule Opacification Development With Two Different Intraocular Lenses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY

Brief Summary:

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.


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: posterior capsular opacification (PCO) [ Time Frame: 3 years ]

subjective and objective PCO scoring


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • best corrected visual acuity (BCVA) [ Time Frame: 3 years ]
  • Nd:YAG rate [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: November 22, 2012
Date Started: January 2009
Date Completion:
Last Updated: November 22, 2012
Last Verified: November 2012