Posterior Capsule Opacification Development With Two Different Intraocular Lenses

Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01734343

Acronym

MIPHY

Enrollment

Registered

2012-11-27

Start date

2009-01-31

Completion date

2012-06-30

Last updated

2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Posterior Capsule Opacification

Keywords

posterior capsule opacification, PCO, after cataract, intraocular lens

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.

Interventions

DEVICEHOYA iMics Y-60H

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

DEVICEPhysIOL microAY

same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
posterior capsular opacification (PCO)	3 years	subjective and objective PCO scoring

Secondary

Measure	Time frame
best corrected visual acuity (BCVA)	3 years
Nd:YAG rate	3 years

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026