Clinical Investigation of Omega Refractive Capsule, Model VI
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cataract
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).Masking: Single (Participant)Masking Description: subject masked to treatmentPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Description
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved I...
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design. Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule VI with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
Tracking Information
- NCT #
- NCT04574115
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Claudio Orlich, MD
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