CataractPhase 4NCT07790887
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 study testing PureSee IOL in people with Cataract, run by Vance Thompson Vision at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- PureSee IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Kayla Karpuk, OD, 6053717083, kayla.karpuk@vancethompsonvision.com
About this study
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
- Being tested
- PureSee IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PureSee IOLDevice
Bilateral implantation of the TECNIS PureSee extended depth of focus IOL
| Study group | Role | What they receive |
|---|---|---|
| Participants with cataracts who choose to undergo cataract surgery | Experimental | Not described Receives: Device: PureSee IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively
Measured: 1 month and 3 months post cataract surgery
Monocular and binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm
Measured: 3 months post cataract surgery
Patient-reported spectacle independence for distance, intermediate, and near tasks assessed via validated questionnaire (AIOLIS questionnaire)
Measured: 3 months post cataract surgery
Secondary outcomes (3)
Monocular and binocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months postoperatively
Measured: 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
Measured: 3 months post cataract surgery
Rate (%) of visual disturbances using the AIOLIS validated questionnaire
Measured: 3 months post cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790887
- Sponsor's protocol ID
- IIT-PS-001
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07790887
- Acronym / sponsor ID
- IIT-PS-001
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with cataracts who choose to undergo cataract surgery | Experimental | Device: PureSee IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PureSee IOLBilateral implantation of the TECNIS PureSee extended depth of focus IOL | Device | Participants with cataracts who choose to undergo cataract surgery |
Primary outcome
Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively
Time frame: 1 month and 3 months post cataract surgery
Monocular and binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm
Time frame: 3 months post cataract surgery
Patient-reported spectacle independence for distance, intermediate, and near tasks assessed via validated questionnaire (AIOLIS questionnaire)
Time frame: 3 months post cataract surgery
3 secondary outcomes
Monocular and binocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months postoperatively
Time frame: 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
Time frame: 3 months post cataract surgery
Rate (%) of visual disturbances using the AIOLIS validated questionnaire
Time frame: 3 months post cataract surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PureSee IOL in people with Cataract, run by Vance Thompson Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Karpuk, OD (605-361-3937, kayla.karpuk@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.