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Clinical Trials/NCT01734343
NCT01734343
Completed
Not Applicable

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

Medical University of Vienna1 site in 1 country65 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posterior Capsule Opacification
Sponsor
Medical University of Vienna
Enrollment
65
Locations
1
Primary Endpoint
posterior capsular opacification (PCO)
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rupert Menapace

Ao.Univ.-Prof. Dr.med.univ.

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • bilateral age-related cataract
  • good overall physical constitution

Exclusion Criteria

  • previous intraocular surgery or ocular trauma
  • intraocular complication like posterior capsular tear
  • 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

Outcomes

Primary Outcomes

posterior capsular opacification (PCO)

Time Frame: 3 years

subjective and objective PCO scoring

Secondary Outcomes

  • best corrected visual acuity (BCVA)(3 years)
  • Nd:YAG rate(3 years)

Study Sites (1)

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