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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
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna

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.


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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
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
PhysIOL microAY
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



Primary Outcome Measures :
  1. posterior capsular opacification (PCO) [ Time Frame: 3 years ]
    subjective and objective PCO scoring


Secondary Outcome Measures :
  1. best corrected visual acuity (BCVA) [ Time Frame: 3 years ]
  2. Nd:YAG rate [ Time Frame: 3 years ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

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


Locations
Austria
Department of Ophthalmology and Optometry of the Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Rupert Menapace, Prof. Dr. Medical University of Vienna

Responsible Party: Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01734343     History of Changes
Other Study ID Numbers: EK Nr:847/2010
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Rupert Menapace, Medical University of Vienna:
posterior capsule opacification
PCO
after cataract
intraocular lens

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases