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

Sponsor
Vienna Hospital Association
Study ID
NCT07688681
Status
Not Yet Recruiting

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Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2029
Completion
Apr 1, 2029

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tecnis PureSee
    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.
  • Active Comparator: 1stQ Comfort Z-EDOF
    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.

Primary Outcome Measure

Monocular distance-corrected defocus range (DCDR) at 0.2 logMAR [ Time Frame: 6 months after surgery ]

Central Contacts

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