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

Cataract Clinical Trial

Official title:

Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248572
• Other study ID #: LTHD-10-03
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2010
• Last updated: March 17, 2014
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2014
• Source: Lenstec Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Eye Centers of Florida	Ft. Myers	Florida
United States	Barnet-Dulaney-Perkins Eye Center	Phoenix	Arizona
United States	Harbin Clinic	Rome	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Lenstec Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No