A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 280
Summary
- Conditions
- Cataract
- Refractive Error
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Care Provider)Masking Description: Unmasked study personnel at the site will be trained to the randomization process through the EDC system and will randomize subjects. The surgeon and the operative staff will know which lens type is implanted. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study site staff will be instructed not to disclose the lens type the subject received or to talk about the lens to any masked evaluators or to the study subjects. The subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject masking, a temporary IOL implant identification card will be issued to the subject at the time of surgery. Following completion of the final study exam, each subject will be given the permanent IOL implant identification card.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04156737
- Collaborators
- Not Provided
- Investigators
- Study Director: Devi Priya Janakiraman, OD, FAAO Johnson & Johnson Surgical Vision
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