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 Recruiting Phase 4 FDA Device

• 1 other identifier: IIT-PS-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively

  1 month and 3 months post cataract surgery

• Monocular and binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm

  3 months post cataract surgery

• Patient-reported spectacle independence for distance, intermediate, and near tasks assessed via validated questionnaire (AIOLIS questionnaire)

  3 months post cataract surgery

Secondary Outcomes (3)

• Monocular and binocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months postoperatively

  3 months post cataract surgery

• Manifest refraction spherical equivalent (MRSE) and percentage of eyes within ±0.50 D and ±1.00 D of the refractive target

  3 months post cataract surgery

• Rate (%) of visual disturbances using the AIOLIS validated questionnaire

  3 months post cataract surgery

Study Arms (1)

Participants with cataracts who choose to undergo cataract surgery

EXPERIMENTAL

Device: PureSee IOL

Interventions

PureSee IOL DEVICE

Bilateral implantation of the TECNIS PureSee extended depth of focus IOL

Participants with cataracts who choose to undergo cataract surgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior intraocular or corneal refractive surgery in the operative eye(s)
• Irregular corneal astigmatism, keratoconus, pellucid marginal degeneration, or other ectatic disease
• 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
• Pupil abnormalities, zonular instability, pseudoexfoliation, or any condition predisposing to intraoperative or postoperative IOL instability
• History of ocular trauma or uveitis
• Uncontrolled systemic disease that in the opinion of the investigator would interfere with study participation or healing

Sponsors & Collaborators

• Vance Thompson Vision: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Kayla Karpuk, OD

CONTACT

605-361-3937; kayla.karpuk@vancethompsonvision.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

US (1)