Status:
COMPLETED
Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
Lead Sponsor:
Lenstec Incorporated
Conditions:
Cataract
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 determin...
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 predi...
Eligibility Criteria
Inclusion
- \>=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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01248572
Start Date
October 1 2010
End Date
March 1 2012
Last Update
March 18 2014
Active Locations (3)
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1
Barnet-Dulaney-Perkins Eye Center
Phoenix, Arizona, United States, 85016
2
Eye Centers of Florida
Fort Myers, Florida, United States, 33901
3
Harbin Clinic
Rome, Georgia, United States, 30165