Posterior Capsule Opacification Development With Two Different Intraocular Lenses (MIPHY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01734343
First received: November 22, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 Intervention
Posterior Capsule Opacification
Cataract
Device: HOYA iMics Y-60H
Device: PhysIOL microAY

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • posterior capsular opacification (PCO) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    subjective and objective PCO scoring


Secondary Outcome Measures:
  • best corrected visual acuity (BCVA) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Nd:YAG rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 22, 2012
Last Updated: November 22, 2012
Health Authority: Austria: Ethikkommission
Austria: Federal Ministry for Health and Women

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

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

ClinicalTrials.gov processed this record on October 29, 2014