Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00760487
Collaborator
(none)
120
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AcrySof Toric IOL
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jun 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Experimental: AcrySof Toric IOL

AcrySof Toric Intraocular Lens (IOL)

Device: AcrySof Toric IOL
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity (VA) [Pre-operative, 1 month, 3 month, and 6 month post-operative]

    Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

Secondary Outcome Measures

  1. Spectacle Independence [6 months post-operative]

    Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit

  2. IOL Rotation [6 months post-operative]

    Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Are a candidate for bilateral implantation

  • In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes

  • In need of spherical correction between 10.0 Diopter (D) and 30.0 D

  • Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry

  • Willing and able to complete all required postoperative visits

  • Able to comprehend and sign a statement of informed consent

  • Pupil dilation ≥ 6.0 mm

  • Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

Exclusion Criteria:

Exclusion Criteria Before Surgery - Ocular

  • Previous cataract patient without potential of bilateral implantation

  • Females of child bearing potential

  • Irregular corneal astigmatism

  • Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana

  • Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis

  • Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)

  • Clinically significant corneal dystrophy (including Fuch's dystrophy)

  • Previous corneal transplant

  • Amblyopia

  • Glaucoma (medically uncontrolled)

  • Clinically significant RPE/Macular changes

  • Proliferative diabetic retinopathy

  • History of macular edema

  • Previous history of retinal detachment

  • History of uveitis/iritis

  • Extremely shallow anterior chamber, not due to swollen cataract

  • Iris neovascularization

  • Microphthalmos

  • Absent eye or eye with no light perception (NLP) as fellow eye

  • Rubella, congenital, traumatic, or complicated cataract

  • Optic atrophy

Exclusion Criteria During Surgery

  • Other procedures at this surgery

  • Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT, for the duration of the study

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:
, ,
ClinicalTrials.gov Identifier:
NCT00760487
Other Study ID Numbers:
  • ALCONsurtor001.06
First Posted:
Sep 26, 2008
Last Update Posted:
Jan 16, 2012
Last Verified:
Jan 1, 2012
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 one or both eyes.
Pre-assignment DetailSubject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Arm/Group TitleAcrySof Toric IOL
Arm/Group DescriptionImplantation of the AcrySof Toric Intraocular lens (IOL)
Period Title: Overall Study
STARTED120
COMPLETED117
NOT COMPLETED3

Baseline Characteristics

Arm/Group TitleAcrySof Toric IOL
Arm/Group DescriptionImplantation of the AcrySof Toric Intraocular lens (IOL)
Overall Participants120
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
77
64.2%
>=65 years
43
35.8%
Sex: Female, Male (Count of Participants)
Female
79
65.8%
Male
41
34.2%

Outcome Measures

1. Primary Outcome
TitleVisual Acuity (VA)
DescriptionPre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Time FramePre-operative, 1 month, 3 month, and 6 month post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleAcrySof Toric IOL
Arm/Group DescriptionImplantation of the AcrySof Toric Intraocular lens (IOL)
Measure Participants117
Pre-Operative
0.7
(0.06)
1 Day Post-operative
0.06
(0.12)
3 Months Post-operative
0.05
(0.11)
6 Months Post-operative
0.05
(0.11)
2. Secondary Outcome
TitleSpectacle Independence
DescriptionPercentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
Time Frame6 months post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleAcrySof Toric IOL
Arm/Group DescriptionImplantation of the AcrySof Toric Intraocular lens (IOL)
Measure Participants117
Number [Percentage of participants]
69
57.5%
3. Secondary Outcome
TitleIOL Rotation
DescriptionEvaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.
Time Frame6 months post-operative

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleAcrySof Toric IOL
Arm/Group DescriptionImplantation of the AcrySof Toric Intraocular lens (IOL)
Measure Participants117
Less than or equal to 5 degrees
91
75.8%
Less than or equal to 10 degrees
99
82.5%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleAcrySof Toric IOL
Arm/Group DescriptionImplantation of the AcrySof Toric Intraocular lens (IOL)
All Cause Mortality
AcrySof Toric IOL
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
AcrySof Toric IOL
Affected / at Risk (%)# Events
Total0/120 (0%)
Other (Not Including Serious) Adverse Events
AcrySof Toric IOL
Affected / at Risk (%)# Events
Total1/120 (0.8%)
Surgical and medical procedures
Lens Repositioning1/120 (0.8%) 1

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:
NCT00760487
Other Study ID Numbers:
  • ALCONsurtor001.06
First Posted:
Sep 26, 2008
Last Update Posted:
Jan 16, 2012
Last Verified:
Jan 1, 2012