search
Back to results

ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

Primary Purpose

Bilateral Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts;
  • Calculated lens power is within the available range;
  • Willing and able to complete all required postoperative visits;
  • Planned cataract removal by phacoemulsification;
  • Potential postoperative visual acuity of 0.2 logMAR or better in study eyes;
  • Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study;
  • Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye;
  • Clear intraocular media other than cataract;
  • Able to comprehend and sign a statement of informed consent;
  • Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR;
  • Pupil size greater than or equal to 6 mm after dilation;
  • The subject must be able to undergo second eye surgery within 30 days of first eye surgery.

Exclusion Criteria:

  • Irregular corneal astigmatism;
  • Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana;
  • Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis;
  • Previous corneal refractive surgery;
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR;
  • Amblyopia;
  • Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
  • Diabetic retinopathy;
  • Extremely shallow anterior chamber, not due to swollen cataract;
  • Microphthalmos;
  • Previous retinal detachment;
  • Previous corneal transplant;
  • Recurrent severe anterior or posterior segment inflammation of unknown etiology;
  • Rubella or traumatic cataract;
  • Iris neovascularization;
  • Uncontrolled glaucoma;
  • Aniridia;
  • Optic nerve atrophy;
  • Pregnancy;
  • Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toric Intraocular Lens

Arm Description

ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.
Reduction of Cylinder
Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.
Lens Axis Misalignment
Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2009
Last Updated
November 18, 2016
Sponsor
Alcon Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00967473
Brief Title
ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toric Intraocular Lens
Arm Type
Experimental
Arm Description
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8
Intervention Type
Device
Intervention Name(s)
ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
Intervention Description
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
Description
Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.
Time Frame
Before Surgery and 180 days after second eye implant
Title
Reduction of Cylinder
Description
Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.
Time Frame
6 months after surgery on second eye
Title
Lens Axis Misalignment
Description
Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.
Time Frame
Time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts; Calculated lens power is within the available range; Willing and able to complete all required postoperative visits; Planned cataract removal by phacoemulsification; Potential postoperative visual acuity of 0.2 logMAR or better in study eyes; Preoperative astigmatism of 4.11 - 4.62 Diopter (D) of predicted crossed cylinder as calculated by the study specific web-based Alcon® Toric IOL Calculator in the first operative eye. Corneal incisions made to reduce astigmatism will not be allowed during the course of the study; Preoperative astigmatism of 3.60 - 4.62 D of predicted crossed cylinder as calculated by study specific web-based Alcon® Toric IOL Calculator in the second operative eye; Clear intraocular media other than cataract; Able to comprehend and sign a statement of informed consent; Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR; Pupil size greater than or equal to 6 mm after dilation; The subject must be able to undergo second eye surgery within 30 days of first eye surgery. Exclusion Criteria: Irregular corneal astigmatism; Keratopathy/Keratectasia - any corneal abnormality, other than regular corneal astigmatism, including but not limited to the following; keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and corneal plana; Any inflammation or edema (swelling) of the cornea, including but not limited to the following; keratitis, keratoconjunctivitis, and keratouveitis; Previous corneal refractive surgery; Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR; Amblyopia; Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy); Diabetic retinopathy; Extremely shallow anterior chamber, not due to swollen cataract; Microphthalmos; Previous retinal detachment; Previous corneal transplant; Recurrent severe anterior or posterior segment inflammation of unknown etiology; Rubella or traumatic cataract; Iris neovascularization; Uncontrolled glaucoma; Aniridia; Optic nerve atrophy; Pregnancy; Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

We'll reach out to this number within 24 hrs