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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07790887

Enrollment

Registered

2026-08-27

Start date

2026-09-01

Completion date

2027-09-01

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

DEVICEPureSee IOL

Bilateral implantation of the TECNIS PureSee extended depth of focus IOL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Contacts

CONTACTKayla Karpuk, OD

kayla.karpuk@vancethompsonvision.com605-361-3937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026