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

Use our guide to learn which trials are right for you!

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