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Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

Primary Purpose

Cataract

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Model SC9
Model LI61SE
Sponsored by
CORD, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts
  • Able to comprehend and sign a statement of informed consent
  • Willing and able to complete all required postoperative visits
  • Calculated Lens Power within the available range for the study IOL's
  • Planned cataract removal by phacoemulsification
  • Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes
  • Subjects with less than 1.0D of corneal astigmatism
  • Clear intraocular media other than cataract in the study eye
  • Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare
  • Pupil size greater or equal to 6.0mm after dilation

Exclusion Criteria:

  • Any corneal abnormality, other than regular corneal astigmatism
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32)
  • Previous refractive surgery
  • Amblyopia
  • Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
  • Diabetic retinopathy
  • Extremely shallow anterior chamber, not due to swollen cataract
  • Microphthalmos
  • Previous retinal detachment
  • Previous corneal surgery
  • Recurrent severe anterior or posterior segment inflammation of unknown etiology
  • Rubella or traumatic cataract
  • Iris Neovascularization
  • Glaucoma (uncontrolled or controlled with medication)
  • Aniridia
  • Optic nerve atrophy
  • Damaged incomplete zonules
  • Systemic disease that could increase the operative risk or confound the outcome
  • Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)

Sites / Locations

  • Davies Eye Center
  • Harvard Eye Associates
  • Coastal Vision Laser Eye Center
  • Shasta Eye Medical Group, Inc.
  • Aker-Kasten Eye Center
  • The Eye Institute of West Florida
  • Chu Vision Institute
  • Silverstein Eye Centers
  • Center for Sight
  • Fine, Hoffman and Sims
  • Houston Eye Associates
  • Parkhurst NuVision
  • Eye Associates of South Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Model SC9

Model LI61SE

Arm Description

Investigational IOL

FDA Approved IOL

Outcomes

Primary Outcome Measures

Improvement in Visual Acuity Measurements using the LogMar Scale
Subjects must read 20/40 or better, distance corrected near visual acuity and 20/40 or better distance corrected intermediate visual acuity. This is achieved with the subject wearing their best corrected spectacle correction in place and reading a series of letters at 40cm/16" and 80cm/32". Total letters read for each line will determine their visual acuity

Secondary Outcome Measures

Defocus testing in 0.5D increments from -0.5 to -5.00D
A sub-set of 50 subjects will undergo defocus testing with their best distance correction in place. Minus Lenses in 0.5D increments will be placed over their best spectacle correction. Total letters read for each diopter will be recorded. Percentage of eyes with improvement of monocular depth of focus by at least 0.5D mean difference between the Model SC9 and control lens.(significance level of 0.025). To demonstrate superiority of at least 0.5D compared to the control lens >75% of eyes implanted with the Model SC9 should demonstrate superiority by at least 0.5D mean difference compared to the control lens.

Full Information

First Posted
May 29, 2017
Last Updated
August 28, 2023
Sponsor
CORD, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03179397
Brief Title
Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)
Official Title
A Clinical Trial to Evaluate the Safety and Effectiveness of Model SC9 Silicone IOL for the Visual Correction of Aphakia Secondary to the Removal of a Cataractous Lens in Adult Patients With or Without Presbyopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor did not recruit enough subjects to file PMA.
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
July 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CORD, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.
Detailed Description
Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb). Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects). Subjects will be followed for 36 Months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Enrolled subjects will not be told which IOL they have received until the end of the study
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Model SC9
Arm Type
Experimental
Arm Description
Investigational IOL
Arm Title
Model LI61SE
Arm Type
Active Comparator
Arm Description
FDA Approved IOL
Intervention Type
Device
Intervention Name(s)
Model SC9
Intervention Description
Experimental
Intervention Type
Device
Intervention Name(s)
Model LI61SE
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
Improvement in Visual Acuity Measurements using the LogMar Scale
Description
Subjects must read 20/40 or better, distance corrected near visual acuity and 20/40 or better distance corrected intermediate visual acuity. This is achieved with the subject wearing their best corrected spectacle correction in place and reading a series of letters at 40cm/16" and 80cm/32". Total letters read for each line will determine their visual acuity
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Defocus testing in 0.5D increments from -0.5 to -5.00D
Description
A sub-set of 50 subjects will undergo defocus testing with their best distance correction in place. Minus Lenses in 0.5D increments will be placed over their best spectacle correction. Total letters read for each diopter will be recorded. Percentage of eyes with improvement of monocular depth of focus by at least 0.5D mean difference between the Model SC9 and control lens.(significance level of 0.025). To demonstrate superiority of at least 0.5D compared to the control lens >75% of eyes implanted with the Model SC9 should demonstrate superiority by at least 0.5D mean difference compared to the control lens.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts Able to comprehend and sign a statement of informed consent Willing and able to complete all required postoperative visits Calculated Lens Power within the available range for the study IOL's Planned cataract removal by phacoemulsification Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes Subjects with less than 1.0D of corneal astigmatism Clear intraocular media other than cataract in the study eye Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare Pupil size greater or equal to 6.0mm after dilation Exclusion Criteria: Any corneal abnormality, other than regular corneal astigmatism Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32) Previous refractive surgery Amblyopia Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy) Diabetic retinopathy Extremely shallow anterior chamber, not due to swollen cataract Microphthalmos Previous retinal detachment Previous corneal surgery Recurrent severe anterior or posterior segment inflammation of unknown etiology Rubella or traumatic cataract Iris Neovascularization Glaucoma (uncontrolled or controlled with medication) Aniridia Optic nerve atrophy Damaged incomplete zonules Systemic disease that could increase the operative risk or confound the outcome Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hovanesian, M.D.
Organizational Affiliation
CORD, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Davies Eye Center
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Coastal Vision Laser Eye Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Aker-Kasten Eye Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
The Eye Institute of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Center for Sight
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Fine, Hoffman and Sims
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Eye Associates of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78247
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

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