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OpenTrials
Completed

NCT Number: NCT03831074

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. Posterior capsule opacification

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2019
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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