A Prospective, Single-Arm Clinical Evaluation of Visual, Refractive, and Patient-Reported Outcomes Following Bilateral Implantation of the TECNIS PureSee™ Extended Depth of Focus Intraocular Lens
Part of paid clinical trials in Sioux Falls, South Dakota.
- Sponsor
- Vance Thompson Vision
- Study ID
- NCT07790887
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Cataract
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PureSee IOL — DEVICEBilateral implantation of the TECNIS PureSee extended depth of focus IOL
Study Details
Assess the visual, refractive, and patient-reported outcomes - including spectacle independence - of bilateral cataract surgery with implantation of the TECNIS PureSee extended depth of focus (EDOF) IOL in subjects with visually significant cataract in a real-world setting.
Key Dates
- First listed
- Aug 27, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Jul 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants with cataracts who choose to undergo cataract surgery
Primary Outcome Measure
Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively [ Time Frame: 1 month and 3 months post cataract surgery ]
Central Contacts
- Kayla Karpuk, OD605-361-3937
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 |
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