Clinical trial NCT00760487: Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract AcrySof Toric IOL
Bilateral cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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:

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

Primary outcomes:
measure: Visual Acuity (VA)
timeFrame: Pre-operative, 1 month, 3 month, and 6 month post-operative
Secondary outcomes:
measure: Spectacle Independence
timeFrame: 6 months post-operative
measure: IOL Rotation
timeFrame: 6 months post-operative
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References: