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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01732484
Collaborator
(none)
100
Enrollment
2
Arms
37
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: intraocular lens implantation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Posterior Capsule Opacification (PCO) [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 Outcome Measures

  1. Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy [3 years]

    Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Rupert Menapace, MD, Medical University Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rupert Menapace, Prof. Dr. Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01732484
Other Study ID Numbers:
  • EK1444/2012
First Posted:
Nov 22, 2012
Last Update Posted:
Jun 5, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePatients Included
Arm/Group Description
Period Title: Overall Study
STARTED100
Randomized100
Allocation100
COMPLETED74
NOT COMPLETED26

Baseline Characteristics

Arm/Group TitleCataract Surgery
Arm/Group Descriptioneyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
Overall Participants100
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
0
0%
>=65 years
100
100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
72
(9)
Gender (participants) [Number]
Female
42
42%
Male
32
32%
Region of Enrollment (participants) [Number]
Austria
100
100%

Outcome Measures

1. Primary Outcome
TitlePosterior Capsule Opacification (PCO)
DescriptionPCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)
Time Frame3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleiMics1 NY-60AcrySof SN60WF
Arm/Group Descriptioneyes with implantation of iMics1 NY-60 IOLeyes with implantation of AcrySof SN60WF IOL
Measure Participants7474
Mean (Standard Deviation) [units on a scale (0-10)]
3.0
(2.0)
1.9
(1.4)
2. Secondary Outcome
TitlePercentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy
DescriptionTreatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values
Time Frame3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleiMics1 NY-60AcrySof SN60WF
Arm/Group Descriptioneyes with implantation of iMics1 NY-60 IOLeyes with implantation of AcrySof SN60WF IOL
Measure Participants7474
Measure eyes148148
Number [percentage of eyes]
26
(0)
10
(0)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleiMics1 NY-60AcrySof SN60WF
Arm/Group Descriptioneyes with implantation of iMics1 NY-60 IOLeyes with implantation of AcrySof SN60WF IOL
All Cause Mortality
iMics1 NY-60AcrySof SN60WF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
iMics1 NY-60AcrySof SN60WF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/100 (0%) 0/100 (0%)
Other (Not Including Serious) Adverse Events
iMics1 NY-60AcrySof SN60WF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/100 (0%) 0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleProf. Dr. R. Menapace
OrganizationMedical University of Vienna
Phone+43 699 19660272
Emailrupert.menapace@meduniwien.ac.at
Responsible Party:
Rupert Menapace, Prof. Dr. Rupert Menapace, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01732484
Other Study ID Numbers:
  • EK1444/2012
First Posted:
Nov 22, 2012
Last Update Posted:
Jun 5, 2013
Last Verified:
Apr 1, 2013