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Clinical Trials/NCT03831074
NCT03831074CompletedNot Applicable

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

Medical University of Vienna0 sitesStarted: January 27, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Primary Endpoint
Posterior capsule opacification

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Posterior capsule opacification

Time Frame: 3 years

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katharina Kriechbaum

Assoc. Prof. Dr.

Medical University of Vienna

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