Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
- Conditions
- Cataract
- Interventions
- Device: AcrySof Toric IOL
- Registration Number
- NCT00760487
- Lead Sponsor
- Alcon Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AcrySof Toric IOL AcrySof Toric IOL AcrySof Toric Intraocular Lens (IOL)
- Primary Outcome Measures
Name Time Method Visual Acuity (VA) Pre-operative, 1 month, 3 month, and 6 month post-operative 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
Name Time Method Spectacle Independence 6 months post-operative Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
IOL Rotation 6 months post-operative 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.
Trial Locations
- Locations (1)
Alcon Call Center
🇺🇸Fort Worth, Texas, United States