Clinical Investigation of Omega Refractive Capsule Model V With Use of an FDA Approved IOL
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 V 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: subjects will be 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 V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IO...
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 V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
Tracking Information
- NCT #
- NCT04574102
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Claudio Orlich, MD
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