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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT01248572
First received: November 24, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cataract
Device: Softec HD IOL
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens

Resource links provided by NLM:


Further study details as provided by Lenstec Incorporated:

Primary Outcome Measures:
  • Effective Lens Position [ Time Frame: 6 Months Postoperative ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Softec HD IOL 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248572

Locations
United States, Arizona
Barnet-Dulaney-Perkins Eye Center
Phoenix, Arizona, United States, 85016
United States, Florida
Eye Centers of Florida
Ft. Myers, Florida, United States, 33901
United States, Georgia
Harbin Clinic
Rome, Georgia, United States, 30165
Sponsors and Collaborators
Lenstec Incorporated
  More Information

No publications provided

Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT01248572     History of Changes
Other Study ID Numbers: LTHD-10-03
Study First Received: November 24, 2010
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Lenstec Incorporated:
Cataract
Biaspheric intraocular lens
Uniplanar intraocular lens
Effective lens position

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014