Clinical Evaluation of a 1-Piece Intraocular Lens

NCT ID: NCT01098812

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-10-31

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

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control IOL

Approved Intraocular control lens

Group Type: ACTIVE_COMPARATOR

Tecnis ZCB00 IOL (control)

Intervention Type: DEVICE

Tecnis 1-piece acrylic IOL

Toric IOL

Investigational Toric IOL

Group Type: EXPERIMENTAL

Toric Intraocular lens

Intervention Type: DEVICE

Toric acrylic intraocular lens with various cylinder powers

Higher Cylinder Toric IOL

Investigational Toric IOLs with higher cylinder powers.

Group Type: EXPERIMENTAL

Toric Intraocular lens

Intervention Type: DEVICE

Toric acrylic intraocular lens with various cylinder powers

Interventions

Tecnis ZCB00 IOL (control)

Tecnis 1-piece acrylic IOL

Intervention Type: DEVICE

Toric Intraocular lens

Toric acrylic intraocular lens with various cylinder powers

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Tarantino, O.D.

Role: STUDY_DIRECTOR

Abbott Medical Optics

Other Identifiers

TIOL-103-TCNS

Identifier Type: -

Identifier Source: org_study_id