Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL

Lenstec

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: Softec HD IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01248572

LTHD-10-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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