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

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.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: Model SC9; Device: Model LI61SE

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.

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92008
      • Davies Eye Center
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
    • Orange, California, United States, 92868
      • Coastal Vision Laser Eye Center
    • Redding, California, United States, 96001
      • Shasta Eye Medical Group, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Aker-Kasten Eye Center
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Silverstein Eye Centers
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • Center for Sight
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Fine, Hoffman and Sims
  • Texas
    • Houston, Texas, United States, 77008
      • Houston Eye Associates
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
    • San Antonio, Texas, United States, 78247
      • Eye Associates of South Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Model SC9; Investigational IOL	Device: Model SC9; Experimental
Active Comparator: Model LI61SE; FDA Approved IOL	Device: Model LI61SE; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Visual Acuity Measurements using the LogMar Scale	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	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defocus testing in 0.5D increments from -0.5 to -5.00D	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.	12 Months

Collaborators and Investigators

• Sponsor: CORD, LLC
• Investigators: Study Chair: John Hovanesian, M.D., CORD, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): October 4, 2021
• Study Completion (Actual): July 22, 2023

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: SC9-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes