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CompletedNCT01732484Updated Jun 5, 2013Results posted

Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two Microincision IOLs: Hoya iMics NY-60 vs Acrysof SN60WF

An interventional study of intraocular lens implantation in Capsule Opacification, Pseudophakia and Cataract, sponsored by Medical University of Vienna. Completed. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by Medical University of Vienna · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
100
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) over a period of 3 years.

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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 100 is above 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.

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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
100 participants (actual)

Study arms

  • Other
    iMics1 NY-60

    eyes with implantation of iMics1 NY-60 IOL

    Procedure: intraocular lens implantation

  • Other
    AcrySof SN60WF

    eyes with implantation of AcrySof SN60WF IOL

    Procedure: intraocular lens implantation

Interventions

  • Procedureintraocular lens implantation
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What researchers measure

Primary outcomes

  1. Posterior Capsule Opacification (PCO)

    PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)

    Time frame: 3 years

Secondary outcomes

  1. Percentage of Eyes With 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 percentage values

    Time frame: 3 years

07

Results

Posted Jun 5, 2013

Participant flow

Participant flow — Overall Study
MilestonePatients Included
Started100
Randomized100
Allocation100
Completed74
Not completed26
Withdrew: Death7
Withdrew: Lost to follow-up14
Withdrew: Chronical illness5

Outcome measures

PrimaryPosterior Capsule Opacification (PCO)

PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)

Time frame:
3 years
Reported as:
Mean · units on a scale (0-10)
Posterior Capsule Opacification (PCO)
units on a scale (0-10)iMics1 NY-60AcrySof SN60WF
Posterior Capsule Opacification (PCO)3.0 ± 2.01.9 ± 1.4
SecondaryPercentage of Eyes With 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 percentage values

Time frame:
3 years
Reported as:
Number · percentage of eyes
Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy
percentage of eyesiMics1 NY-60AcrySof SN60WF
Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy26 ± 010 ± 0

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
iMics1 NY-60—0/100 (0%)0/100 (0%)
AcrySof SN60WF—0/100 (0%)0/100 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cataract Surgery
<=18 years0
Between 18 and 65 years0
>=65 years100
Age Continuous
Age Continuous(years)Cataract Surgery
Mean72 ± 9
Gender
Gender(participants)Cataract Surgery
Female42
Male32
Region of Enrollment
Region of Enrollment(participants)Cataract Surgery
Austria100
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Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01732484
Responsible party
Rupert Menapace (Prof. Dr. Rupert Menapace, Medical University of Vienna) — Principal investigator
First posted
Nov 22, 2012
Start date
Aug 2009
Primary completion
May 2010
Completion
Sep 2012
Results posted
Jun 5, 2013
Last update
Jun 5, 2013

Study contacts

Rupert Menapace, MD
principal investigator · Medical University Vienna
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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