Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Tecnis ZCB00 and Acrysof SA60AT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01742910
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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) with different design of the sharp posterior edge within a follow up period of three years.


Condition Intervention
Capsule Opacification
Pseudophakia
Cataract
Procedure: intraocular lens implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Posterior capsule opacification (PCO) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery


Secondary Outcome Measures:
  • frequency of neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in absolute and relative (percentage) values


Enrollment: 54
Study Start Date: April 2008
Study Completion Date: October 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tecnis ZCB00
eyes with implantation of Tecnis ZCB00
Procedure: intraocular lens implantation
Acrysof SA60AT
eyes with implantation of Acrysof SA60AT
Procedure: intraocular lens implantation

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742910

Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Rupert Menapace, Prof. Dr. Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01742910     History of Changes
Other Study ID Numbers: EK128/2008
Study First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Pseudophakia
Cataract
Capsule Opacification
Signs and Symptoms
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014