Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00710931
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
23
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AcrySof ReSTOR Aspheric IOL model SN6AD1
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: ReSTOR +3 Multifocal Lens

Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)

Device: AcrySof ReSTOR Aspheric IOL model SN6AD1
Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.

Outcome Measures

Primary Outcome Measures

  1. Binocular Visual Acuity at Distance, Near and Intermediate [6 months after surgery]

    Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
Exclusion Criteria:
  • Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

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:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00710931
Other Study ID Numbers:
  • ALCONsur001.08
First Posted:
Jul 8, 2008
Last Update Posted:
Dec 12, 2011
Last Verified:
Dec 1, 2011
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleReSTOR +3 Multifocal Lens
Arm/Group DescriptionBilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Period Title: Overall Study
STARTED34
COMPLETED29
NOT COMPLETED5

Baseline Characteristics

Arm/Group TitleReSTOR +3 Multifocal Lens
Arm/Group DescriptionBilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Overall Participants34
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]
74.5
(6.44)
Sex: Female, Male (Count of Participants)
Female
18
52.9%
Male
16
47.1%

Outcome Measures

1. Primary Outcome
TitleBinocular Visual Acuity at Distance, Near and Intermediate
DescriptionUncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Time Frame6 months after surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleReSTOR +3 Multifocal Lens
Arm/Group DescriptionBilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Measure Participants34
Uncorrected VA at 4 m
0.00
(0.08)
Uncorrected VA at 60 cm
0.13
(0.11)
Uncorrected VA best near (39.69 cm +/- 4.09 cm)
0.07
(0.08)
Best Corrected VA at 4 m
0.00
(0.06)
Best Corrected VA at 60 cm
0.09
(0.11)
Best Corrected VA best near (41.31 cm +/- 5.82 cm)
0.07
(0.08)

Adverse Events

Time Frame
Adverse Event Reporting Description Adverse events were not collected in this study.
Arm/Group TitleReSTOR +3 Multifocal Lens
Arm/Group DescriptionBilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
All Cause Mortality
ReSTOR +3 Multifocal Lens
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
ReSTOR +3 Multifocal Lens
Affected / at Risk (%)# Events
Total0/0 (NaN)
Other (Not Including Serious) Adverse Events
ReSTOR +3 Multifocal Lens
Affected / at Risk (%)# Events
Total0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

When a clinical study report or manuscript, in lieu of a final report, is completed, Alcon will provide the summary findings of the study to the investigator.

Results Point of Contact

Name/TitleDirector of Alcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00710931
Other Study ID Numbers:
  • ALCONsur001.08
First Posted:
Jul 8, 2008
Last Update Posted:
Dec 12, 2011
Last Verified:
Dec 1, 2011