MIPHY: Posterior Capsule Opacification Development With Two Different Intraocular Lenses

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01734343

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Arm

Intervention/Treatment

Other: 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

Other: 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

Outcome Measures

Primary Outcome Measures

posterior capsular opacification (PCO) [3 years]
subjective and objective PCO scoring

Secondary Outcome Measures

best corrected visual acuity (BCVA) [3 years]
Nd:YAG rate [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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