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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:2/23/2019
Start Date:May 31, 2017
End Date:September 1, 2021
Contact:Lynne Archer
Email:larcher@cordsc9.com
Phone:714-651-6333

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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

To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate
vision when compared to a legally marketed monofocal IOL.

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.

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)
We found this trial at
13
sites
San Antonio, Texas 78229
Principal Investigator: Gregory D Parkhurst, M.D.
Phone: 210-615-9358
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San Antonio, TX
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Bloomington, Minnesota 55420
Principal Investigator: Y. Ralph Chu, M.D.
Phone: 952-835-4768
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Bloomington, MN
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1445 Northwest Boca Raton Boulevard
Boca Raton, Florida 33432
Principal Investigator: Jill F Rodila, MD
Phone: 561-338-7722
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Boca Raton, FL
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Carlsbad, California 92008
Principal Investigator: James Davies, M.D.
Phone: 760-729-7101
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Carlsbad, CA
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Dallas, Texas 75205
Principal Investigator: Harvey L Carter, MD
Phone: 214-750-1962
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Dallas, TX
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Eugene, Oregon 97401
Principal Investigator: Richard S Hoffman, MD
Phone: 541-687-2110
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Eugene, OR
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Houston, Texas 77025
Principal Investigator: William "Colby" Stewart, MD
Phone: 832-553-7133
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Houston, TX
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Laguna Hills, California 92653
Principal Investigator: John Hovanesian, MD
Phone: 949-842-9954
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Laguna Hills, CA
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Largo, Florida 33770
Principal Investigator: Robert Weinstock, MD
Phone: 727-450-4668
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Largo, FL
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Las Vegas, Nevada 89145
Principal Investigator: Eva Liang, M.D.
Phone: 702-724-2005
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Las Vegas, NV
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293 Main Street
Orange, California 92868
Principal Investigator: Dan B Tran, MD
Phone: 949-842-9954
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Orange, CA
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Redding, California
Principal Investigator: Bruce Silverstein, M.D.
Phone: 530-241-4065
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Redding, CA
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Sacramento, California 95816
Principal Investigator: Keith Liang, MD
Phone: 916-446-2020
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Sacramento, CA
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