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

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ClinicalTrials.gov Identifier: NCT03179397
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
CORD, LLC

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.

Condition or disease Intervention/treatment Phase
Cataract Device: Model SC9 Device: Model LI61SE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Enrolled subjects will not be told which IOL they have received until the end of the study
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2023

Arm Intervention/treatment
Experimental: Model SC9
Investigational IOL
Device: Model SC9
Experimental

Active Comparator: Model LI61SE
FDA Approved IOL
Device: Model LI61SE
Active Comparator




Primary Outcome Measures :
  1. Improvement in Visual Acuity Measurements using the LogMar Scale [ Time Frame: 12 Months ]
    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 :
  1. Defocus testing in 0.5D increments from -0.5 to -5.00D [ Time Frame: 12 Months ]
    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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179397


Contacts
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Contact: Lynne Archer 714-651-6333 larcher@cordsc9.com
Contact: Tonya Porter 909-717-4493 tporter@cordsc9.com

Locations
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United States, California
Davies Eye Center Recruiting
Carlsbad, California, United States, 92008
Contact: Sherry Bishop    760-729-7101    sherry@davieseye.com   
Contact: Amanda Agcaoili    760-729-7101    amanda@davieseye.com   
Principal Investigator: James Davies, M.D.         
Harvard Eye Associates Recruiting
Laguna Hills, California, United States, 92653
Contact: Natalie Edwards    949-842-9954    nedwards@harvardeye.com   
Principal Investigator: John Hovanesian, MD         
Coastal Vision Laser Eye Center Recruiting
Orange, California, United States, 92868
Contact: Natalie Edwards    949-842-9954    nedwardsresearch@gmail.com   
Principal Investigator: Dan B Tran, MD         
Shasta Eye Medical Group, Inc. Not yet recruiting
Redding, California, United States, 96001
Contact: Sandra Kelly    530-241-4065 ext 2104    skelly@shastaeye.com   
Contact: Kelly Miller    530-241-4065 ext 2104    kmiller@shastaeye.com   
Principal Investigator: Bruce Silverstein, M.D.         
Center for Sight Withdrawn
Sacramento, California, United States, 95816
United States, Florida
Aker-Kasten Eye Center Recruiting
Boca Raton, Florida, United States, 33432
Contact: Lisa Di Rico - Truax, COMT    561-338-7722 ext 331    ltruax@akerkasten.com   
Principal Investigator: Jill F Rodila, MD         
Sub-Investigator: Alan Aker, MD         
The Eye Institute of West Florida Active, not recruiting
Largo, Florida, United States, 33770
United States, Minnesota
Chu Vision Institute Recruiting
Bloomington, Minnesota, United States, 55420
Contact: Nic Jacobs    952-835-4768    nic.jacobs@chuvision.com   
Principal Investigator: Y. Ralph Chu, M.D.         
United States, Missouri
Silverstein Eye Centers Recruiting
Kansas City, Missouri, United States, 64133
Contact: Cindy E Bentley    818-595-3958    cbentley@silversteineyecenters.com   
Principal Investigator: Steven Silverstein, M.D.         
United States, Nevada
Center for Sight Not yet recruiting
Las Vegas, Nevada, United States, 89145
Contact: Jodi Kennedy    702-724-2005    jodi.kennedy@c4slv.com   
Principal Investigator: Eva Liang, M.D.         
United States, Oregon
Fine, Hoffman and Sims Recruiting
Eugene, Oregon, United States, 97401
Contact: Stephanie Neubert    541-687-2110    stephanie@finemd.com   
Principal Investigator: Richard S Hoffman, MD         
United States, Texas
Carter Eye Center Withdrawn
Dallas, Texas, United States, 75205
Houston Eye Associates Recruiting
Houston, Texas, United States, 77008
Contact: Tammy Parsons    832-553-7133    tparsons@houstoneye.com   
Principal Investigator: William "Colby" Stewart, MD         
Parkhurst NuVision Recruiting
San Antonio, Texas, United States, 78229
Contact: Magen Taylor    210-615-9358    mtaylor@parkhurstnuvision.com   
Principal Investigator: Gregory D Parkhurst, M.D.         
Eye Associates of South Texas Recruiting
San Antonio, Texas, United States, 78247
Contact: Mary-Jenn Saunders    210-269-4075    maryjenns@eyestx.com   
Contact: Patricia Lynn    210-342-2020    patricial@eyestx.com   
Principal Investigator: Joseph T Kavanagh, M.D.         
Sub-Investigator: Sharon Acosta, M.D.         
Sponsors and Collaborators
CORD, LLC
Investigators
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Study Chair: J Stuart Cumming, M.D. CORD, LLC

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Responsible Party: CORD, LLC
ClinicalTrials.gov Identifier: NCT03179397     History of Changes
Other Study ID Numbers: SC9-0015
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases