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

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

Treatments tested in this trial

  • Tecnis PureSee IOL implantation
  • 1stQ Comfort Z-EDOF IOL implantation

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators