Clinical trial NCT03179397: 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
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Lead sponsor: CORD, LLC
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 338
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Improvement in Visual Acuity Measurements using the LogMar Scale
timeFrame: 12 Months
Secondary outcomes:
measure: Defocus testing in 0.5D increments from -0.5 to -5.00D
timeFrame: 12 Months
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Davies Eye Center
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Orange
country: United States
facility: Coastal Vision Laser Eye Center
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: Boca Raton
country: United States
facility: Aker-Kasten Eye Center
state: Florida
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Las Vegas
country: United States
facility: Center for Sight
state: Nevada
city: Eugene
country: United States
facility: Fine, Hoffman and Sims
state: Oregon
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: San Antonio
country: United States
facility: Eye Associates of South Texas
state: Texas
Study officials:
affiliation: CORD, LLC
name: John Hovanesian, M.D.
role: STUDY_CHAIR
References: