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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Notify MeKey information
Conditions
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
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
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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