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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Softec HD IOL
Sponsored by
Lenstec Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cataract focused on measuring Cataract, Biaspheric intraocular lens, Uniplanar intraocular lens, Effective lens position

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barnet-Dulaney-Perkins Eye Center
  • Eye Centers of Florida
  • Harbin Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Softec HD IOL

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2010
Last Updated
March 17, 2014
Sponsor
Lenstec Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01248572
Brief Title
Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL
Official Title
Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lenstec Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Biaspheric intraocular lens, Uniplanar intraocular lens, Effective lens position

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Softec HD IOL
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Softec HD IOL
Intervention Description
Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.
Primary Outcome Measure Information:
Title
Effective Lens Position
Description
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.
Time Frame
6 Months Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Barnet-Dulaney-Perkins Eye Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Eye Centers of Florida
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Harbin Clinic
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States

12. IPD Sharing Statement

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

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