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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03831074

Enrollment

Unknown

Registered

2019-02-05

Start date

2012-01-27

Completion date

2015-07-07

Last updated

2019-02-05

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

Conditions

Posterior Capsule Opacification

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.

Interventions

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

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

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