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Not yet recruitingNCT07790887Updated Aug 27, 2026

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

A Phase 4 interventional study of PureSee IOL in Cataract, sponsored by Vance Thompson Vision. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Vance Thompson Vision · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 50 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Participants with cataracts who choose to undergo cataract surgery

    Device: PureSee IOL

Interventions

  • DevicePureSee IOL

    Bilateral implantation of the TECNIS PureSee extended depth of focus IOL

06

What researchers measure

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

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Study locations

1 site
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.

Of 39 non-industry phase 4 interventional studies under Cataract, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 10 months is below that.

Counting every sponsor, half of 46 studies reached it within 20 months; a quarter within 11 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartEst.
Sep 2026
Primary completionEst.
Jul 2027
CompletionEst.
Sep 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07790887
Lead sponsor
Vance Thompson Vision
Collaborators
Johnson & Johnson
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Kayla Karpuk, OD
Contact
kayla.karpuk@vancethompsonvision.com
605-361-3937

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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