Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00762021
Collaborator
(none)
104
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: SN60AT
  • Device: SN60WF
N/A

Study Design

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

Arms and Interventions

ArmIntervention/Treatment
Experimental: SN60AT

Implantation with the AcrySof Intraocular Lens Model SN60AT

Device: SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.

Active Comparator: SN60WF

Implantation with the AcrySof Intraocular Lens Model SN60WF

Device: SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.

Outcome Measures

Primary Outcome Measures

  1. Posterior Capsule Opacification (PCO) [2 years after surgery]

    Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.

  2. 100% LogMAR Best Corrected Visual Acuity (BCVA) [24 months after surgery]

    Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

  3. 9% LogMAR Best Corrected Visual Acuity (BCVA) [24 months after surgery]

    Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with bilateral senile cataracts

  • Age > 50 years

  • Fit for hospital follow ups

  • Pupils dilating > 6mm preoperatively

  • Eyes expected to see 6/12 or better postoperatively

Exclusion Criteria:
  • Diabetes

  • On treatment for glaucoma

  • Other ocular pathology

  • Previous ocular surgery

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00762021
Other Study ID Numbers:
  • P-06-26
First Posted:
Sep 30, 2008
Last Update Posted:
Dec 22, 2010
Last Verified:
Nov 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsUncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye
Pre-assignment DetailDuring the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Arm/Group TitleSN60ATSN60WF
Arm/Group DescriptionImplantation with the AcrySof Intraocular Lens Model SN60ATImplantation with the AcrySof Intraocular Lens Model SN60WF
Period Title: Overall Study
STARTED5252
COMPLETED4444
NOT COMPLETED88

Baseline Characteristics

Arm/Group TitleSN60ATSN60WFTotal
Arm/Group DescriptionImplantation with the AcrySof Intraocular Lens Model SN60ATImplantation with the AcrySof Intraocular Lens Model SN60WFTotal of all reporting groups
Overall Participants5252104
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
12
23.1%
12
23.1%
24
23.1%
>=65 years
40
76.9%
40
76.9%
80
76.9%
Sex: Female, Male (Count of Participants)
Female
29
55.8%
29
55.8%
58
55.8%
Male
23
44.2%
23
44.2%
46
44.2%

Outcome Measures

1. Primary Outcome
TitlePosterior Capsule Opacification (PCO)
DescriptionThickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.
Time Frame2 years after surgery

Outcome Measure Data

Analysis Population Description
Data for all patients completing the 24 month visit were analyzed.
Arm/Group TitleSN60ATSN60WF
Arm/Group DescriptionImplantation with the AcrySof Intraocular Lens Model SN60ATImplantation with the AcrySof Intraocular Lens Model SN60WF
Measure Participants4040
Mean (Standard Deviation) [Percentage of PCO]
11.58
(20.18)
14.04
(22.15)
2. Primary Outcome
Title100% LogMAR Best Corrected Visual Acuity (BCVA)
DescriptionBest spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame24 months after surgery

Outcome Measure Data

Analysis Population Description
Data for all patients completing the 24 month visit were analyzed.
Arm/Group TitleSN60ATSN60WF
Arm/Group DescriptionImplantation with the AcrySof Intraocular Lens Model SN60ATImplantation with the AcrySof Intraocular Lens Model SN60WF
Measure Participants4040
Mean (Standard Deviation) [LogMAR]
0.04
(0.1)
0.07
(0.2)
3. Primary Outcome
Title9% LogMAR Best Corrected Visual Acuity (BCVA)
DescriptionBest spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame24 months after surgery

Outcome Measure Data

Analysis Population Description
Data for all patients completing the 24 month visit were analyzed.
Arm/Group TitleSN60ATSN60WF
Arm/Group DescriptionImplantation with the AcrySof Intraocular Lens Model SN60ATImplantation with the AcrySof Intraocular Lens Model SN60WF
Measure Participants4040
Mean (Standard Deviation) [LogMAR]
0.42
(0.2)
0.45
(0.2)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleSN60ATSN60WF
Arm/Group DescriptionImplantation with the AcrySof Intraocular Lens Model SN60ATImplantation with the AcrySof Intraocular Lens Model SN60WF
All Cause Mortality
SN60ATSN60WF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
SN60ATSN60WF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/52 (0%) 0/52 (0%)
Other (Not Including Serious) Adverse Events
SN60ATSN60WF
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/52 (0%) 0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publications relating to the study should not be made without the Sponsor's prior written consent and not prior to the completion of the study. The sponsor shall be notified in writing at least 60 days prior to submission of any intention on the part of the Investigator to publish and shall provide the sponsor an opportunity to comment on any proposed publications.

Results Point of Contact

Name/TitleAlcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00762021
Other Study ID Numbers:
  • P-06-26
First Posted:
Sep 30, 2008
Last Update Posted:
Dec 22, 2010
Last Verified:
Nov 1, 2010