Clinical Evaluation of a 1-Piece Intraocular Lens

Cataract Clinical Trial

Official title:

Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098812
• Other study ID #: TIOL-103-TCNS
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2010
• Last updated: June 28, 2013
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis ZCB00 IOL (control)
Tecnis 1-piece acrylic IOL
• Toric Intraocular lens
Toric acrylic intraocular lens with various cylinder powers

Locations

Country	Name	City	State
United States	AMO Clinical Research Call Center for Trial Locations	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Reduction in Cylinder	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.	6 months after second eye implant compared to baseline	No
Secondary	Uncorrected Distance Visual Acuity (UCDVA)	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.	6 months after second eye implant	No