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Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)

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ClinicalTrials.gov Identifier: NCT01786356
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
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 4 years.


Condition or disease Intervention/treatment Phase
Posterior Capsule Opacification Cataract Device: HOYA iMics Y-60H Other: B&L MI60 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : March 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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

B&L MI60
eyes with implanted intraocular lens B&L MI60
Other: B&L MI60
same-day bilateral cataract surgery with implantation of intraocular lens B&L MI60 in one eye




Primary Outcome Measures :
  1. posterior capsular opacification (PCO) [ Time Frame: 4 years ]
    subjective and objective PCO scoring


Secondary Outcome Measures :
  1. best corrected visual acuity (BCVA) [ Time Frame: 4 years ]
  2. Nd:YAG rate [ Time Frame: 4 years ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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): NCT01786356


Locations
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Austria
Department of Ophthalmology and Optometry of the Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01786356    
Other Study ID Numbers: EK Nr: 931/2010
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Rupert Menapace, Medical University of Vienna:
posterior capsule opacification
PCO
after cataract
intraocular lens
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Lens Diseases
Eye Diseases