Prospective, Randomized, Parallel-group Comparison of Two Refractive EDOF Intraocular Lenses: Johnson & Johnson Tecnis PureSee Versus 1stQ Comfort Z-EDOF

NCT07688681 | Not Yet Recruiting

• 1 other identifier: MA_15_EK_26_094_VK
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two types of artificial lens (intraocular lens, or IOL) used during cataract surgery. Both are extended depth-of-focus (EDOF) lenses, designed to give clear vision across a range of distances - far and intermediate - so that people depend less on glasses after surgery. The two lenses, the Tecnis PureSee and the 1stQ Comfort Z-EDOF, use different optical designs, and it is not yet known whether one provides a wider range of clear vision than the other. Adults having cataract surgery in both eyes may take part. Each participant is randomly assigned to receive one of the two lens types, and the same lens type is implanted in both eyes. Neither the participant nor the staff measuring vision knows which lens was used until the main 6-month assessment is complete. After surgery, participants attend check-ups at 1, 3, and 6 months. The study measures how wide a range of distances each person can see clearly, along with vision at different distances, quality of vision, side effects such as glare or halos, and overall satisfaction. The results will help doctors and patients choose between these lens types.

Conditions

Cataract

Keywords

EDOF intraocular lens

Outcome Measures

Primary Outcomes (1)

• Monocular distance-corrected defocus range (DCDR) at 0.2 logMAR

  Maximum contiguous defocus span (in diopters) over which monocular distance-corrected visual acuity remains ≤0.2 logMAR, derived from a standardized defocus curve (4 m ETDRS chart; +1.0 D to -3.5 D in 0.5 D steps).

  6 months after surgery

Secondary Outcomes (1)

• Monocular visual acuity at multiple distances

  6 months after surgery

Study Arms (2)

Tecnis PureSee

EXPERIMENTAL

Bilateral implantation of the Tecnis PureSee refractive extended depth-of-focus IOL (Johnson \& Johnson Vision; non-toric model ZEN00V or toric DET series). The same lens platform is implanted in both eyes. Target refraction: emmetropia in the dominant eye and approximately -0.50 D in the non-dominant eye.

Device: Tecnis PureSee IOL implantation

1stQ Comfort Z-EDOF

ACTIVE COMPARATOR

Bilateral implantation of the 1stQ Comfort Z-EDOF refractive extended depth-of-focus IOL (1stQ GmbH; non-toric models B1XBY0/S1XBY0 or toric B1ZBY0). The same lens platform is implanted in both eyes. Target refraction: emmetropia in the dominant eye and approximately -0.50 D in the non-dominant eye.

Device: 1stQ Comfort Z-EDOF IOL implantation

Interventions

Tecnis PureSee IOL implantation DEVICE

Phacoemulsification with bilateral implantation of the Tecnis PureSee refractive EDOF IOL in the capsular bag. Toric variant used for preoperative corneal astigmatism greater than 0.75 D.

Tecnis PureSee

1stQ Comfort Z-EDOF IOL implantation DEVICE

Phacoemulsification with bilateral implantation of the 1stQ Comfort Z-EDOF refractive EDOF IOL in the capsular bag. Toric variant used for preoperative corneal astigmatism greater than 0.75 D.

1stQ Comfort Z-EDOF

Eligibility Criteria

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

You may qualify if:

• Age ≥40 years, able to understand the study and give written informed consent
• Clinically significant bilateral age-related cataract suitable for phacoemulsification with posterior chamber IOL implantation
• Expected postoperative best-corrected visual acuity ≤0.2 logMAR in both eyes
• Regular corneal astigmatism ≤4.5 D in both eyes (IOLMaster 700)
• Axial length 21.5-26.5 mm in both eyes
• Clear cornea without clinically significant opacities, scars, or stromal dystrophies
• Normal pupil function; no significant anisocoria (≥1 mm) and no afferent pupillary defect
• Acceptance of the target refraction strategy: emmetropia in the dominant eye and -0.50 D in the non-dominant eye
• Willing and able to attend all follow-up visits (Month 1, 3, and 6)
• Written informed consent obtained before any study-related procedure

You may not qualify if:

• Prior corneal refractive surgery, corneal transplantation, glaucoma filtering surgery, or vitreoretinal surgery in either eye (uncomplicated intravitreal injections allowed)
• Irregular astigmatism, keratoconus, forme fruste keratoconus, corneal ectasia, significant corneal opacities or scars, or endothelial dystrophy
• Keratometric astigmatism \>4.5 D in either eye
• Axial length \<21.5 mm or \>26.5 mm in either eye
• Calculated IOL power outside the available range of either study lens
• Macular pathology expected to limit visual acuity (e.g., age-related macular degeneration, diabetic maculopathy, epiretinal membrane, macular hole)
• Advanced glaucoma with central visual field involvement, or IOP not controlled on ≤2 topical medications
• Optic neuropathy expected to limit visual potential
• Pre-existing amblyopia in either eye
• Significant anisocoria, afferent pupillary defect, non-dilating pupil, or iris abnormalities affecting IOL function or measurement
• Endothelial cell density \<1500 cells/mm²
• Uncontrolled diabetes mellitus (HbA1c \>9%) or autoimmune disease with active ocular involvement
• Systemic medications affecting pupil size that cannot be discontinued (e.g., tamsulosin)
• Pregnancy or breastfeeding
• Intraoperative complication precluding safe in-the-bag IOL implantation (affected eyes withdrawn)

Sponsors & Collaborators

• Vienna Hospital Association: lead

Study Sites (1)

Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund

Vienna, State of Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Michal Klimek, MD

CONTACT

+43 650 460 7496; klimek.michael@gmx.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim.a Univ.-Prof.in Dr.in Pia Veronika Vécsei-Marlovits, MSc, MBA

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)