Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00934622
Collaborator
(none)
76
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Mar 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Experimental: AcrySof® ReSTOR® Aspheric IOL

AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)

Device: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery]

    Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

  1. Spectacle Independence [pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery]

    Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 21 years or older;

  • need spherical correction between 10-30 Diopters (D);

  • corneal astigmatism less than 0.75D as measured by keratometry;

  • willing to sign an Informed Consent Form and complete all visits;

  • pupil dilation greater than 6mm;

  • expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion Criteria:
  • Women of childbearing potential;

  • irregular corneal astigmatism;

  • keratopathy/keratectasia;

  • cornea inflammation or edema;

  • cornea reshaping surgery;

  • corneal dystrophy;corneal transplant;

  • amblyopia;

  • glaucoma;

  • Retinal Pigment Epitheliopathy (RPE)/Macular changes;

  • proliferative diabetic retinopathy

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:
NCT00934622
Other Study ID Numbers:
  • ALCONsur002.07
First Posted:
Jul 8, 2009
Last Update Posted:
May 6, 2010
Last Verified:
May 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects >21 years of age, either sex, and any race. Diagnosis of cataracts in both eyes. 27-Jun-2007 to 20-May-2009
Pre-assignment DetailSubject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Arm/Group TitleAcrySof® ReSTOR® Aspheric IOL
Arm/Group DescriptionAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Period Title: Overall Study
STARTED76
COMPLETED68
NOT COMPLETED8

Baseline Characteristics

Arm/Group TitleAcrySof® ReSTOR® Aspheric IOL
Arm/Group DescriptionAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Overall Participants76
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
33
43.4%
>=65 years
43
56.6%
Gender (participants) [Number]
Female
48
63.2%
Male
27
35.5%

Outcome Measures

1. Primary Outcome
TitleVisual Acuity
DescriptionComparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Framepre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleAcrySof® ReSTOR® Aspheric IOL
Arm/Group DescriptionAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Measure Participants76
Preoperative
0.54
(0.3)
1 Week
0.06
(0.12)
1 Month
0.03
(0.08)
3 Months
0.04
(0.08)
6 Months
0.05
(0.09)
2. Secondary Outcome
TitleSpectacle Independence
DescriptionSpectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.
Time Framepre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery

Outcome Measure Data

Analysis Population Description
Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.
Arm/Group TitleAcrySof® ReSTOR® Aspheric IOL
Arm/Group DescriptionAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Measure Participants76
Preoperative
29
38.2%
1 Week Postoperative
96.8
127.4%
1 Month Postoperative
97.2
127.9%
3 Months Postoperative
98.6
129.7%
6 Months Postoperative
100
131.6%

Adverse Events

Time FrameJune 27, 2007 (First Subject, first visit) through August 1, 2009 (Last subject, last visit)
Adverse Event Reporting Description
Arm/Group TitleAcrySof® ReSTOR® Aspheric IOL
Arm/Group DescriptionAcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
All Cause Mortality
AcrySof® ReSTOR® Aspheric IOL
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
AcrySof® ReSTOR® Aspheric IOL
Affected / at Risk (%)# Events
Total0/76 (0%)
Other (Not Including Serious) Adverse Events
AcrySof® ReSTOR® Aspheric IOL
Affected / at Risk (%)# Events
Total0/76 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/TitleAlcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00934622
Other Study ID Numbers:
  • ALCONsur002.07
First Posted:
Jul 8, 2009
Last Update Posted:
May 6, 2010
Last Verified:
May 1, 2010