NCT Number: NCT01732484
Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Hoya iMics NY-60 vs Acrysof SN60WF
Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 have some cataract development in one or both eyes. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted. It is estimated that around 10 million cataract operations are performed around the world each year. Cataract operations are generally very successful, with a low risk of serious complications. The most common risk is developing a condition called posterior capsule opacification (PCO), which causes impaired vision to return.
During the past two decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). In the past few years, refinements in surgical technique and modifications in IOL design and material have led to a decrease in the incidence of PCO.
It has been shown that a sharp posterior optic edge inhibits migration of lens epithelial cells (LEC) behind the IOL optic and therefore have a lower incidence of posterior capsule opacification (PCO). Most IOL designs have open-loop haptics that are connected to the optic towards the end of the production process, also called multipiece designs.
For several reasons such as better ease of use with injector systems and higher efficiency in the production process, companies have developed IOLs with open-loop haptics out of one block of material, also called single-piece designs. In the case of such single-piece IOLs, the haptics tend to be much thicker than with multipiece IOLs. A potential drawback of the thick haptics maybe an incomplete closure of the capsule at the optic rim with a reduced bending effect of the posterior capsule around the posterior optic edge. Additionally, the posterior sharp edge is often discontinuous in the region of the haptic-optic junctions. These locations may serve as a scaffold for LECs to migrate behind the IOL optic resulting in PCO. Nowadays a multitude of different single piece IOLS are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.
The purpose of this study is to compare the intensity of posterior capsule opacification (PCO) between two different 1-piece foldable hydrophobic acrylic intraocular lenses (IOLs) over a period of 3 years.
Looking for future studies?
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
- good overall physical constitution
Exclusion criteria
- history of ocular disease or intraocular surgery
- laser treatment
- diabetes requiring medical control
- glaucoma
- severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
Treatment and study plan
Primary outcomes
-
Posterior Capsule Opacification (PCO)
Time frame: 3 years
PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)
Secondary outcomes
-
Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy
Time frame: 3 years
Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values
Sponsors and collaborators
Lead sponsor
Medical University of Vienna
Other
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2010
- Study completion
- 2012
- First posted
- Nov 22, 2012
- Registry last updated
- Jun 5, 2013
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Tecnis ZCB00 and Acrysof SA60AT
NCT01742910
Capsule Opacification, Cataract
Vienna, Austria
View Trial DetailsProphylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy
NCT07729189
Capsule Opacification, Cataract
Multan, Punjab Province, Pakistan
View Trial DetailsEffect of Optic Edge Design in a Silicone Intraocular Lens on Posterior Capsule Opacification
NCT00428363
Capsule Opacification, Cataract
Vienna, State of Vienna, Austria
View Trial DetailsVisual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
NCT06460389
Cataract, Eye Diseases
Alexandroupoli, Evros, Greece
View Trial Details