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

Medical University of Vienna

Status: Completed

Conditions: Cataract; Posterior Capsule Opacification

Treatments: Device: PhysIOL microAY; Device: HOYA iMics Y-60H

Study type: Interventional

Funder types: Other

Identifiers

NCT01734343

EK Nr:847/2010

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

HOYA iMics Y-60H

Other group

Description:

eyes with implanted intraocular lens HOYA iMics Y-60H

Treatment:

Device: HOYA iMics Y-60H

PhysIOL microAY

Other group

Description:

eyes with implanted intraocular lens PhysIOL microAY

Treatment:

Device: PhysIOL microAY