Clinical trial NCT01248572: Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
Official title: Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Biaspheric intraocular lens
Uniplanar intraocular lens
Effective lens position
Lead sponsor: Lenstec Incorporated
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.

Detailed description: The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.

Eligibility criteria: Inclusion Criteria:

* \>=40 years of age, of any race and either gender
* Operable, age related cataract grade 3+ or lower in the study eye
* Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
* ≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
* Able to achieve a dilated pupil \>6.0 millimeter (mm) in the study eye
* Able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (UBM) unit (preoperatively)
* Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
* In good general and ocular health
* Able to competently complete testing
* Willing and able to attend study visits
* Willing and able to understand and sign an informed consent

Exclusion Criteria:

* Previous intraocular surgery or laser treatment
* Severe dry eye
* Uncontrolled IOP or glaucoma
* Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
* History of retinal detachment
* Microphthalmia
* Chronic severe uveitis
* Corneal decompensation
* Irregular astigmatism
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
* Pseudoexfoliation syndrome
* Iris atrophy
* Pupil abnormalities (e.g., corectopia)
* Aniseikonia
* Amblyopia
* An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
* Pregnant, lactating, or planning to become pregnant during the course of the trial
* Participation in another clinical trial within 30 days of study start

Primary outcomes:
measure: Effective Lens Position
timeFrame: 6 Months Postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barnet-Dulaney-Perkins Eye Center
state: Arizona
city: Ft. Myers
country: United States
facility: Eye Centers of Florida
state: Florida
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
Study officials:
References: