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

ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorVienna Hospital Association

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Tecnis PureSeeExperimental treatment 1 intervention
Group B: 1stQ Comfort Z-EDOFActive comparator 1 intervention

Trial outcomes

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).

Time frame
6 months after surgery

Secondary outcomes

1

Monocular visual acuity at multiple distances

logMAR acuity: UDVA and CDVA (4 m); UIVA at 66 cm and 80 cm and DCIVA (intermediate); UNVA at 40 cm and DCNVA (near).

Time frame
6 months after surgery

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: