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

NCT01248572 | Completed Phase 4

• 1 other identifier: LTHD-10-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Cataract

Keywords

Cataract; Biaspheric intraocular lens; Uniplanar intraocular lens; Effective lens position

Outcome Measures

Primary Outcomes (1)

• Effective Lens Position

  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.

  6 Months Postoperative

Study Arms (1)

Softec HD IOL

EXPERIMENTAL

Device: Softec HD IOL

Interventions

Softec HD IOL 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.

Softec HD IOL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lenstec Incorporated: lead

Study Sites (3)

Barnet-Dulaney-Perkins Eye Center

Phoenix, Arizona, 85016, United States

Location

Eye Centers of Florida

Fort Myers, Florida, 33901, United States

Location

Harbin Clinic

Rome, Georgia, 30165, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

US (3)