Clinical Investigation of the Next-Generation Intraocular Lenses
Public ClinicalTrials.gov record NCT03372434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.
Study identification
- NCT ID
- NCT03372434
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
- Investigational Intraocular Lens Device #1: Model ZFR00 Device
- Investigational Intraocular Lens Device #1: Model ZYR00 Device
- TECNIS Multifocal Intraocular Lens: Model ZLB00 Device
Device
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2018 (Actual)
- Primary completion
- Jul 11, 2018 (Actual)
- Completion
- Oct 30, 2018 (Actual)
- Last update posted
- Jun 24, 2025
2018
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | — |
| Katzen Eye Care and Laser Center | Boynton Beach | Florida | 33426 | — |
| Chesapeake Eye Care & Laser Center | Annapolis | Maryland | 21401 | — |
| Eye Doctors of Washington | Chevy Chase | Maryland | 20815 | — |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | — |
| Carolina EyeCare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | — |
| Loden Vision Centers | Goodlettsville | Tennessee | 37072 | — |
| Eye Specialty Group | Memphis | Tennessee | 38120 | — |
| Texas Eye and Laser Center | Hurst | Texas | 76054 | — |
| Lehmann Eye Center | Nacogdoches | Texas | 75965 | — |
| Focal Point Vision | San Antonio | Texas | 78209 | — |
| Clarus Eye Centre | Lacey | Washington | 98503 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03372434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03372434 live on ClinicalTrials.gov.