Clinical Evaluation of a 1-Piece Intraocular Lens

Abbott

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Device: Tecnis ZCB00 IOL (control); Device: Toric Intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01098812

TIOL-103-TCNS

Details and patient eligibility

About

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

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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269 participants in 3 patient groups

Control IOL

Active Comparator group

Description:

Approved Intraocular control lens

Treatment:

Device: Tecnis ZCB00 IOL (control)

Toric IOL

Experimental group

Description:

Investigational Toric IOL

Treatment:

Device: Toric Intraocular lens

Higher Cylinder Toric IOL

Experimental group

Description:

Investigational Toric IOLs with higher cylinder powers.

Treatment:

Device: Toric Intraocular lens