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

NCT03831074 | Completed

• 1 other identifier: 933/2011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Posterior Capsule Opacification

Outcome Measures

Primary Outcomes (1)

• Posterior capsule opacification

  Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software

  3 years

Interventions

Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G DEVICE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Officials

• Katharina Kriechbaum

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 5, 2019
• Study Start: January 27, 2012
• Primary Completion: July 7, 2015
• Study Completion: July 7, 2015
• Last Updated: February 5, 2019

Record last verified: 2019-02