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CompletedNCT01742910Updated Dec 6, 2012

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

An interventional study of intraocular lens implantation in Capsule Opacification, Pseudophakia and Cataract, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-12-06.

Sponsored by Medical University of Vienna · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Capsule Opacification
  • Pseudophakia
  • Cataract
03

In context

Capsule Opacification

28 studies on the registry are indexed under Capsule Opacification; 2 are open to participants now.

This study's enrollment of 54 is below the median of 63 across 16 interventional studies indexed under Capsule Opacification.

Browse Capsule Opacification studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Bilateral age-related cataract
  • Good overall physical constitution

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Other
    Tecnis ZCB00

    eyes with implantation of Tecnis ZCB00

    Procedure: intraocular lens implantation

  • Other
    Acrysof SA60AT

    eyes with implantation of Acrysof SA60AT

    Procedure: intraocular lens implantation

Interventions

  • Procedureintraocular lens implantation
06

What researchers measure

Primary outcomes

  1. Posterior capsule opacification (PCO)

    PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery

    Time frame: 3 years

Secondary outcomes

  1. frequency of neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy

    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

    Time frame: 3 years

07

Study locations

1 site
  • Medical University Vienna
    Vienna, 1090, Austria
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2008, a primary completion of Jun 2011 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2012
First posted
Dec 6, 2012
Start
Apr 2008
Primary completionActual
Jun 2011
CompletionActual
Oct 2012
Last update
Dec 6, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01742910
Responsible party
Rupert Menapace (Prof. Dr. Rupert Menapace, Medical University of Vienna) — Principal investigator
First posted
Dec 6, 2012
Start date
Apr 2008
Primary completion
Jun 2011
Completion
Oct 2012
Last update
Dec 6, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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