Clinical Evaluation of a 1-Piece Intraocular Lens

Phase 3

Completed

Conditions: Cataract

Interventions: Device: Tecnis ZCB00 IOL (control)
Device: Toric Intraocular lens

Registration Number: NCT01098812

Lead Sponsor: Abbott Medical Optics

Brief Summary: The aims of this study are to:

* Demonstrate a reduction in postoperative cylinder compared to results from the control lens

* Demonstrate better uncorrected distance visual acuity compared to the control lens

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 269

Inclusion Criteria

Minimum 18 years of age
Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes
Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye
BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye
Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL)
Clear intraocular media other than cataract in both eyes
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
Signed informed consent and HIPAA authorization

Exclusion Criteria

Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters
Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye
Previous corneal or intraocular surgery in either eye
Irregular corneal astigmatism in either eye
Corneal pathology/abnormality potentially affecting topography in either eye
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye
Inability to achieve keratometric stability in either eye for contact lens wearers
Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure
Use of systemic or ocular medications that may affect vision
Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure
Poorly-controlled diabetes
Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye
Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control IOL	Tecnis ZCB00 IOL (control)	Approved Intraocular control lens
Toric IOL	Toric Intraocular lens	Investigational Toric IOL
Higher Cylinder Toric IOL	Toric Intraocular lens	Investigational Toric IOLs with higher cylinder powers.

Primary Outcome Measures

Name	Time	Method
Mean Percent Reduction in Cylinder	6 months after second eye implant compared to baseline	Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.

Secondary Outcome Measures

Name	Time	Method
Uncorrected Distance Visual Acuity (UCDVA)	6 months after second eye implant	Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.