Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses

The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary.

As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.

Study Overview

• Status: Completed
• Conditions: Posterior Capsule Opacification
• Intervention / Treatment: Device: Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
• Age 40 and older
• Visual potential in both eyes of 20/30 or better as determined by investigators estimation
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Preceding ocular surgery or trauma
• Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.)
• Uncontrolled systemic or ocular disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior capsule opacification	Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software	3 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Katharina Kriechbaum, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2012
• Primary Completion (Actual): July 7, 2015
• Study Completion (Actual): July 7, 2015

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: 933/2011