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

NCT ID: NCT01786356

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-01-31

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.

Conditions

Posterior Capsule Opacification; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

HOYA iMics Y-60H

eyes with implanted intraocular lens HOYA iMics Y-60H

Group Type: OTHER

HOYA iMics Y-60H

Intervention Type: DEVICE

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

Group Type: OTHER

B&L MI60

Intervention Type: OTHER

same-day bilateral cataract surgery with implantation of intraocular lens B\&L MI60 in one eye

Interventions

HOYA iMics Y-60H

same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye

Intervention Type: DEVICE

B&L MI60

same-day bilateral cataract surgery with implantation of intraocular lens B\&L MI60 in one eye

Intervention Type: OTHER

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
• 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rupert Menapace

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

EK Nr: 931/2010

Identifier Type: -

Identifier Source: org_study_id