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

NCT ID: NCT03831074

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-27
• Study Completion Date: 2015-07-07

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Katharina Kriechbaum

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katharina Kriechbaum

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Other Identifiers

933/2011

Identifier Type: -

Identifier Source: org_study_id