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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

NCT07790887

Not Yet RecruitingPhase 4

Sponsor: Vance Thompson Vision

Conditions: Cataract

Interventions: PureSee IOL

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Adults aged ≥40 years with bilateral visually significant cataracts electing to undergo cataract surgery
2. Calculated IOL power within the available PureSee power range
3. Both eyes targeted for plano (first minus recommended) in both eyes
4. Preoperative corneal astigmatism ≤0.75 D for non-toric PureSee, or within the treatment range of the PureSee Toric platform
5. Potential postoperative best-corrected distance visual acuity of 20/25 or better in each eye
6. Willing and able to comply with the scheduled visits and study procedures

Exclusion Criteria:

1. Prior intraocular or corneal refractive surgery in the operative eye(s)
2. Irregular corneal astigmatism, keratoconus, pellucid marginal degeneration, or other ectatic disease
3. Clinically significant macular pathology, advanced glaucoma with field loss, amblyopia, or any concurrent ocular condition that would limit BCVA at the discretion of the investigator
4. Pupil abnormalities, zonular instability, pseudoexfoliation, or any condition predisposing to intraoperative or postoperative IOL instability
5. History of ocular trauma or uveitis
6. Uncontrolled systemic disease that in the opinion of the investigator would interfere with study participation or healing

Locations (1)

Sioux Falls, South Dakota, United States