Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07688681

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

Sponsor: Vienna Hospital Association

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-08-01

Completion Date

2029-04-01

Last Updated

2026-07-07

Healthy Volunteers

Conditions

Cataract

Interventions

DEVICE

Tecnis PureSee IOL implantation

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.

DEVICE

1stQ Comfort Z-EDOF IOL implantation

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Cognitive impairment, language barrier, or other factors preventing reliable participation * Current enrollment in another interventional clinical study affecting visual outcomes

Locations (1)

Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund

Vienna, State of Vienna, Austria