Clinical trial NCT00967473: ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Cataract
Keywords: Astigmatism
cataract
corneal astigmatism
IOL
AcrySof
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment
timeFrame: Before Surgery and 180 days after second eye implant
measure: Reduction of Cylinder
timeFrame: 6 months after surgery on second eye
measure: Lens Axis Misalignment
timeFrame: Time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References: