Clinical trial NCT01098812: Clinical Evaluation of a 1-Piece Intraocular Lens
Official title: Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract, Intraocular lens
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2010-04-05
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean Percent Reduction in Cylinder
timeFrame: 6 months after second eye implant compared to baseline
Secondary outcomes:
measure: Uncorrected Distance Visual Acuity (UCDVA)
timeFrame: 6 months after second eye implant
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Medical Optics
name: Nicholas Tarantino, O.D.
role: STUDY_DIRECTOR
References: