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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AcrySof Toric IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract AcrySof Toric IOL, Bilateral cataract

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcon Call Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AcrySof Toric IOL

Arm Description

AcrySof Toric Intraocular Lens (IOL)

Outcomes

Primary Outcome Measures

Visual Acuity (VA)
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

Spectacle Independence
Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
IOL Rotation
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.

Full Information

First Posted
September 25, 2008
Last Updated
January 12, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00760487
Brief Title
Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract AcrySof Toric IOL, Bilateral cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AcrySof Toric IOL
Arm Type
Experimental
Arm Description
AcrySof Toric Intraocular Lens (IOL)
Intervention Type
Device
Intervention Name(s)
AcrySof Toric IOL
Intervention Description
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments
Primary Outcome Measure Information:
Title
Visual Acuity (VA)
Description
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).
Time Frame
Pre-operative, 1 month, 3 month, and 6 month post-operative
Secondary Outcome Measure Information:
Title
Spectacle Independence
Description
Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
Time Frame
6 months post-operative
Title
IOL Rotation
Description
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.
Time Frame
6 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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

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