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

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: Softec HD IOL

• Registration Number: NCT01248572
• Lead Sponsor: Lenstec Incorporated

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Softec HD IOL	Softec HD IOL	-

Primary Outcome Measures

Name	Time	Method
Effective Lens Position	6 Months Postoperative	The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.

Trial Locations

Locations (3)

Barnet-Dulaney-Perkins Eye Center; 🇺🇸 Phoenix, Arizona, United States

Harbin Clinic; 🇺🇸 Rome, Georgia, United States

Eye Centers of Florida; 🇺🇸 Ft. Myers, Florida, United States