Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00719732
Collaborator
(none)
218
Enrollment
1
Location
1
Arm
20
Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ReSTOR
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
218 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Experimental: ReSTOR Aspheric +3

Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

Device: ReSTOR
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

Outcome Measures

Primary Outcome Measures

  1. Uncorrected Visual Acuity (UCVA) [6 months]

    Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (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:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Diagnosed with cataracts
Exclusion Criteria:
  • Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;

  • <1 diopter astigmatism by keratometry readings.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon 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:
NCT00719732
Other Study ID Numbers:
  • M07-001
  • NCT00762203
First Posted:
Jul 22, 2008
Last Update Posted:
Mar 16, 2010
Last Verified:
Mar 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects 18 - 70 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment DetailSubject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Arm/Group TitleReSTOR Aspheric +3
Arm/Group DescriptionEnrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Period Title: Overall Study
STARTED218
COMPLETED196
NOT COMPLETED22

Baseline Characteristics

Arm/Group TitleReSTOR Aspheric +3
Arm/Group DescriptionEnrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Overall Participants218
Age (participants) [Number]
<=18 years
0
0%
Between 18 and 65 years
143
65.6%
>=65 years
64
29.4%
Gender (participants) [Number]
Female
88
40.4%
Male
124
56.9%

Outcome Measures

1. Primary Outcome
TitleUncorrected Visual Acuity (UCVA)
DescriptionUncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleReSTOR Aspheric +3
Arm/Group DescriptionEnrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Measure Participants196
UCVA at 40 cm
0.05
(0.10)
UCVA at 50 cm
-0.07
(0.15)
UCVA at 60 cm
0.15
(0.14)
UCVA at 70 cm
0.20
(0.13)
UCVA at 4 m
-0.01
(0.11)

Adverse Events

Time FrameUp to 6 months post-operative
Adverse Event Reporting Description Volunteered and solicited adverse events were collected from the time of surgery to the 6 month post-operative visit.
Arm/Group TitleReSTOR Aspheric +3
Arm/Group DescriptionEnrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
All Cause Mortality
ReSTOR Aspheric +3
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
ReSTOR Aspheric +3
Affected / at Risk (%)# Events
Total1/196 (0.5%)
Eye disorders
Chronic inflammation/iritis1/196 (0.5%) 1
Other (Not Including Serious) Adverse Events
ReSTOR Aspheric +3
Affected / at Risk (%)# Events
Total0/196 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.

Results Point of Contact

Name/TitleAlcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00719732
Other Study ID Numbers:
  • M07-001
  • NCT00762203
First Posted:
Jul 22, 2008
Last Update Posted:
Mar 16, 2010
Last Verified:
Mar 1, 2010