Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Public ClinicalTrials.gov record NCT03949335. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization. After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule
Study identification
- NCT ID
- NCT03949335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 272 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2019
- Primary completion
- Jun 17, 2020
- Completion
- Jun 17, 2020
- Last update posted
- Aug 26, 2021
2019 – 2020
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | — |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | — |
| Katzen Eye Care & Laser Center | West Palm Beach | Florida | 33401 | — |
| Jones Eye Clinic | Sioux City | Iowa | 51104 | — |
| Chesapeake Eye Care & Laser Center | Annapolis | Maryland | 21401 | — |
| Cincinnati Eye Institute | Blue Ash | Ohio | 45242 | — |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | — |
| Carolina EyeCare Physicians | Mt. Pleasant | South Carolina | 29464 | — |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | — |
| Key-Whitman Eye Center | Dallas | Texas | 75243 | — |
| Berkeley Eye Institute | Houston | Texas | 77027 | — |
| 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 NCT03949335, 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 Aug 26, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03949335 live on ClinicalTrials.gov.