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

Stopped early · Not applicable

Conditions studied: Cataract

In brief

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

Key facts

Study ID

NCT03179397

Run by

CORD, LLC

People needed

338

Starts

2017-05-31

Expected to finish

2023-07-22

Last updated by the study team

2023-08-30

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Davies Eye Center — Carlsbad, California, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Coastal Vision Laser Eye Center — Orange, California, United States
• Shasta Eye Medical Group, Inc. — Redding, California, United States
• Aker-Kasten Eye Center — Boca Raton, Florida, United States
• The Eye Institute of West Florida — Largo, Florida, United States
• Chu Vision Institute — Bloomington, Minnesota, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• Center for Sight — Las Vegas, Nevada, United States
• Fine, Hoffman and Sims — Eugene, Oregon, United States
• Houston Eye Associates — Houston, Texas, United States
• Parkhurst NuVision — San Antonio, Texas, United States
• Eye Associates of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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