Status:
COMPLETED
Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 deter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00760487
Start Date
October 1 2006
Last Update
January 16 2012
Active Locations (1)
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1
Alcon Call Center
Fort Worth, Texas, United States, 76134