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NCT04210232 · ClinicalTrials.gov registry record · NA
Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
A NA study of Cataract and Corneal Astigmatism, sponsored by Johnson & Johnson Surgical Vision.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 12
- Study locations
NCT04210232: Completed NA study of Cataract and Corneal Astigmatism, sponsored by Johnson & Johnson Surgical Vision.
NCT04210232 is a NA study of Cataract and Corneal Astigmatism that has completed, run by Johnson & Johnson Surgical Vision. The registered enrollment target is 54 participants, below the 228-participant average among 83 other Cataract trials with a reported enrollment target (76% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04210232, a NA study of Cataract and Corneal Astigmatism, has completed, sponsored by Johnson & Johnson Surgical Vision.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.
Primary Outcome
Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).
Conditions Studied
Interventions
- DEVICE TECNIS® TORIC II Intraocular Lens (IOL)
Study Locations (12)
Texas
- Key & Whitman Eye Center - Dallas
- Texas Eye and Laser Center - Hurst
- Parkhurst NuVision - San Antonio
Maryland
- Chesapeake Eye Care and Laser Center - Annapolis
- Eye Doctors of Washington - Chevy Chase
California
- Empire Eye & Laser Center - Bakersfield
Iowa
- Jones Eye Clinic - Sioux City
Michigan
- Oakland Ophthalmic Surgery, P.C. - Birmingham
Missouri
- Tekwani Vision Center - St Louis
Ohio
- Cincinnati Eye Institute - Cincinnati
South Carolina
- Carolina Cataract & Laser Center - Ladson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2020-09-11 |
| Phase | NA |
What the finished NCT04210232 record still lists
NCT04210232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 228-participant average among 83 other Cataract trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Cataract appearing as the primary indexed condition, and to 1 intervention - of which TECNIS® TORIC II Intraocular Lens (IOL) is the first listed.
NCT04210232 lists 12 locations in 9 states (Texas, Maryland, California).
Frequently Asked Questions
What is clinical trial NCT04210232 about?
NCT04210232 is a clinical study titled "Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL". This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.
What is the current status of trial NCT04210232?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2020-01-14. Estimated completion is 2020-09-11.
What conditions does trial NCT04210232 study?
This clinical trial studies the following conditions: Cataract, Corneal Astigmatism.
What interventions are being tested in trial NCT04210232?
The interventions under investigation include: TECNIS® TORIC II Intraocular Lens (IOL) (DEVICE).
Who is sponsoring clinical trial NCT04210232?
This trial is sponsored by Johnson & Johnson Surgical Vision, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04210232 being conducted?
This trial has 12 study locations across California, Iowa, Maryland, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04210232's enrollment target sits among peer trials
54 56th of 83 higher than 28 of 83 other Cataract trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cataract trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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