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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT03831074
Collaborator
(none)
41.3
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G
 N/A

Study Design

Study Type:
Interventional
Official Title:
Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses
Actual Study Start Date :
Jan 27, 2012
Actual Primary Completion Date :
Jul 7, 2015
Actual Study Completion Date :
Jul 7, 2015

Outcome Measures

Primary Outcome Measures

  1. Posterior capsule opacification [3 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Katharina Kriechbaum, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katharina Kriechbaum, Assoc. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03831074
Other Study ID Numbers:
  • 933/2011
First Posted:
Feb 5, 2019
Last Update Posted:
Feb 5, 2019
Last Verified:
Feb 1, 2019
Additional relevant MeSH terms:
Capsule Opacification

Study Results

No Results Posted as of Feb 5, 2019