Posterior Capsule Opacification Development With Two Different Intraocular Lenses

Cataract Clinical Trial

— MIPHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734343
• Other study ID #: EK Nr:847/2010
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: November 22, 2012
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Posterior Capsule Opacification

Intervention

Device:
• HOYA iMics Y-60H
same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
• PhysIOL microAY
same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye

Locations

Country	Name	City	State
Austria	Department of Ophthalmology and Optometry of the Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	posterior capsular opacification (PCO)	subjective and objective PCO scoring	3 years	No
Secondary	best corrected visual acuity (BCVA)		3 years	No
Secondary	Nd:YAG rate		3 years	No