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

Posterior Capsule Opacification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831074
• Other study ID #: 933/2011
• Status: Completed
• Phase: N/A
• Start date: January 27, 2012
• Est. completion date: July 7, 2015

Study information

• Verified date: February 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 7, 2015
• Est. primary completion date: July 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

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