Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00758745
Collaborator
(none)
81
Enrollment
1
Location
2
Arms
47
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Model SN60WF
  • Device: Model MA60AC
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Model SN60WF

Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)

Device: Model SN60WF
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.

Active Comparator: Model MA60AC

Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)

Device: Model MA60AC
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. Posterior Capsule Opacification (PCO) [Up to 3 years]

    Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age > 50 years

  • Clear cornea

  • Pupil mydriasis ≥ 7mm

  • In the bag Intraocular Lens (IOL)

Exclusion Criteria:
  • Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia

  • Previously operated eye

  • Proliferative diabetic retinopathy

  • Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Contact Alcon Call Center for Study LocationsFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758745
Other Study ID Numbers:
  • P-06-03
First Posted:
Sep 25, 2008
Last Update Posted:
Aug 19, 2014
Last Verified:
Aug 1, 2011
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleModel SN60WFModel MA60AC
Arm/Group DescriptionImplantation with the AcrySof Model SN60WF Intraocular Lens (IOL)Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
Period Title: Overall Study
STARTED8181
COMPLETED6060
NOT COMPLETED2121

Baseline Characteristics

Arm/Group TitleModel SN60WFModel MA60ACTotal
Arm/Group DescriptionImplantation with the AcrySof Model SN60WF Intraocular Lens (IOL)Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)Total of all reporting groups
Overall Participants8181162
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
58
71.6%
58
71.6%
116
71.6%
>=65 years
23
28.4%
23
28.4%
46
28.4%
Sex: Female, Male (Count of Participants)
Female
40
49.4%
40
49.4%
80
49.4%
Male
41
50.6%
41
50.6%
82
50.6%

Outcome Measures

1. Primary Outcome
TitlePosterior Capsule Opacification (PCO)
DescriptionDevelopment of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
Time FrameUp to 3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleModel SN60WFModel MA60AC
Arm/Group DescriptionImplantation with the AcrySof Model SN60WF Intraocular Lens (IOL)Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
Measure Participants6060
Mean (Standard Deviation) [Units on a scale]
0.18
(0.41)
0.15
(0.44)

Adverse Events

Time FrameAdverse events were not collected for this study.
Adverse Event Reporting Description
Arm/Group TitleModel SN60WFModel MA60AC
Arm/Group DescriptionImplantation with the AcrySof Model SN60WF Intraocular Lens (IOL)Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
All Cause Mortality
Model SN60WFModel MA60AC
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
Model SN60WFModel MA60AC
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/81 (0%) 0/81 (0%)
Other (Not Including Serious) Adverse Events
Model SN60WFModel MA60AC
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/81 (0%) 0/81 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All study data is held confidential and not be disclosed to a 3rd party without written consent from Alcon Laboratories for a period of 3 years.

Results Point of Contact

Name/TitleDirector of Clinical Research
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758745
Other Study ID Numbers:
  • P-06-03
First Posted:
Sep 25, 2008
Last Update Posted:
Aug 19, 2014
Last Verified:
Aug 1, 2011