Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification

Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits migration of lens epithelial cells in between posterior capsule and optic of the IOL and therefore reduces the rate of posterior capsule opacification (PCO). In present time most IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production different IOLs have different rates of PCO.

Progression in cataract surgery technique allow phacoemulsification through micro-incisions. Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.

This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp posterior optic edge on the rate of PCO after implantation through a micro-incision. The results will be compared intraindividually.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology, Hietzing Hospital

Vienna, 1130, Austria

About this study

prospective, randomized, bilateral study with intraindividual comparison, implantation of a Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye.

PCO rate will be detected at 1 year and 2 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

bilateral age-related cataract
age 55 to 80 years
expected postoperative visual acuity of at least 0.5

Exclusion criteria

amblyopia
corneal scars
diabetes
pseudoexfoliation-syndrome
earlier ocular surgeries or laser treatments
intraocular tumors

Treatment and study plan

cataract surgery

Procedure

cataract surgery with implantation of an IOL

Other names: Polylens Y30 IOL, Polytech, Germany, Polylens Y10 IOL, Polytech, Germany

Primary outcomes

PCO rate

Time frame: 2 years after surgery

Sponsors and collaborators

Lead sponsor

Hospital Hietzing

Other

Registry information

Official study title

Influence of Two Sharp-edged Hydrophobic Acrylic Micro-incision-IOLs on Posterior Capsule Opacification. A Randomized, Double-masked Study With Intraindividual Comparison.

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: May 7, 2008
Registry last updated: Aug 17, 2010

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.

Published trials that share one or more normalized conditions with this study.

Completed