ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

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.

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Key information

Conditions

Bilateral Cataract Astigmatism Cataract Eye Diseases Lens Diseases Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8.

Device

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 outcomes

Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment

Time frame: Before Surgery and 180 days after second eye implant

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

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

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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 27, 2009
Registry last updated: Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed