Rotational Stability of the AcrySof® Toric

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00762216
Collaborator
(none)
71
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AcrySof® Toric intraocular lens
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Rotational Stability of the AcrySof® Toric
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Jun 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Other: Toric

Implantation with the AcrySof® Toric intraocular lens

Device: AcrySof® Toric intraocular lens
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

Outcome Measures

Primary Outcome Measures

  1. Rotational Stability [6 Months post-surgery]

    Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

Secondary Outcome Measures

  1. Residual Refractive Cylinder [6 Months post-surgery]

    The refractive astigmatism 6 months post-surgery, measured in diopters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Monolateral or bilateral cataracts

  • anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D

  • 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings

  • able to sign the informed consent, to comply with scheduled visits and other study procedures

Exclusion Criteria:
  • Preoperative ocular pathology

  • previous intraocular or corneal surgery

  • an increased risk for complications which could require vitreoretinal surgery

  • corneal irregularities

  • corneal opacities

  • current contact lens usage

  • uncontrolled diabetes

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon Call CenterFort 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:
NCT00762216
Other Study ID Numbers:
  • RM-08-001
First Posted:
Sep 30, 2008
Last Update Posted:
Oct 31, 2012
Last Verified:
May 1, 2010
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements
Pre-assignment Detailnon-randomized
Arm/Group TitleToric
Arm/Group DescriptionImplantation with the AcrySof® Toric intraocular lens
Period Title: Overall Study
STARTED71
COMPLETED71
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleToric
Arm/Group DescriptionImplantation with the AcrySof® Toric intraocular lens
Overall Participants71
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
38
53.5%
>=65 years
33
46.5%
Sex: Female, Male (Count of Participants)
Female
33
46.5%
Male
38
53.5%

Outcome Measures

1. Primary Outcome
TitleRotational Stability
DescriptionAverage magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Time Frame6 Months post-surgery

Outcome Measure Data

Analysis Population Description
67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.
Arm/Group TitleToric
Arm/Group DescriptionImplantation with the AcrySof® Toric intraocular lens
Measure Participants67
Mean (Standard Error) [degrees]
4
(3)
2. Secondary Outcome
TitleResidual Refractive Cylinder
DescriptionThe refractive astigmatism 6 months post-surgery, measured in diopters.
Time Frame6 Months post-surgery

Outcome Measure Data

Analysis Population Description
69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.
Arm/Group TitleToric
Arm/Group DescriptionImplantation with the AcrySof® Toric intraocular lens
Measure Participants69
Mean (Standard Error) [diopters]
0.4
(0.4)

Adverse Events

Time Frame
Adverse Event Reporting Description No adverse events were reported for the 71 patients participating in the study.
Arm/Group TitleToric
Arm/Group DescriptionImplantation with the AcrySof® Toric intraocular lens
All Cause Mortality
Toric
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
Toric
Affected / at Risk (%)# Events
Total0/71 (0%)
Other (Not Including Serious) Adverse Events
Toric
Affected / at Risk (%)# Events
Total0/71 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleAlcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00762216
Other Study ID Numbers:
  • RM-08-001
First Posted:
Sep 30, 2008
Last Update Posted:
Oct 31, 2012
Last Verified:
May 1, 2010