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

NCT ID: NCT01248572

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Softec HD IOL

Group Type: EXPERIMENTAL

Softec HD IOL

Intervention Type: DEVICE

Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.

Interventions

Softec HD IOL

Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lenstec Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barnet-Dulaney-Perkins Eye Center

Phoenix, Arizona, United States

Eye Centers of Florida

Fort Myers, Florida, United States

Harbin Clinic

Rome, Georgia, United States

Countries

United States

Other Identifiers

LTHD-10-03

Identifier Type: -

Identifier Source: org_study_id