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NCT Number: NCT07790887

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location contact

Kayla Karpuk, OD

CONTACT

[email protected]

6053717083

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PureSee IOL

Device

Bilateral implantation of the TECNIS PureSee extended depth of focus IOL

Primary outcomes

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

    Time frame: 1 month and 3 months post cataract surgery

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

    Time frame: 3 months post cataract surgery

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

    Time frame: 3 months post cataract surgery

Secondary outcomes

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

    Time frame: 3 months post cataract surgery

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

    Time frame: 3 months post cataract surgery

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

    Time frame: 3 months post cataract surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Karpuk, OD

CONTACT

[email protected]

605-361-3937

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Collaborators

  • Johnson & Johnson

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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