Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 500
Summary
- Conditions
- Cataract
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Enrolled subjects will not be told which IOL they have received until the end of the studyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03179397
- Collaborators
- Not Provided
- Investigators
- Study Chair: J Stuart Cumming, M.D. CORD, LLC
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