ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00967473
First received: August 25, 2009
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Adult Patients With Bilateral Cataracts.
Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment [ Time Frame: Before Surgery and 180 days after second eye implant ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months after surgery on second eye ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toric Intraocular Lens
ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8
Device: ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967473

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Undraa Altangerel, MD\Manager, Surgical Products Clinical Trial Management, Alcon Research
ClinicalTrials.gov Identifier: NCT00967473     History of Changes
Other Study ID Numbers: C-08-062
Study First Received: August 25, 2009
Results First Received: June 23, 2011
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Astigmatism
cataract
corneal astigmatism
IOL
AcrySof

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014