An interventional study of Tecnis PureSee IOL implantation and 1stQ Comfort Z-EDOF IOL implantation in Cataract, sponsored by Vienna Hospital Association. Not yet recruiting at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Vienna Hospital Association · Not applicable, Interventional, and Treatment
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.
Background and rationale: Extended depth-of-focus (EDOF) intraocular lenses (IOLs) extend the range of functional vision beyond that of conventional monofocal IOLs by modifying the eye's wavefront to create an elongated focal range, while aiming to limit the photic phenomena (halos, glare, starbursts) often associated with multifocal IOLs. Different EDOF platforms use fundamentally different optical strategies, yet direct comparative evidence between EDOF designs from prospective randomized trials is limited; most published studies compare an EDOF IOL with monofocal or multifocal lenses rather than with another EDOF design. This trial provides a head-to-head comparison of two purely refractive EDOF platforms that employ different optical principles: the Tecnis PureSee (Johnson \& Johnson Vision), a refractive EDOF design with a continuous power profile and negative spherical aberration, and the 1stQ Comfort Z-EDOF (1stQ GmbH), a refractive aspheric EDOF design with a modified spherical aberration profile.
Design: This is a single-center, prospective, randomized, parallel-group comparative study conducted at the Department of Ophthalmology, Klinik Hietzing, Vienna, Austria. Patients undergoing bilateral cataract surgery are randomized 1:1 to receive one of the two EDOF IOL platforms, implanted bilaterally (the same platform in both eyes). Randomization uses permuted blocks and is stratified by toric versus non-toric IOL variant; patients with preoperative corneal astigmatism greater than 0.75 D receive the toric version of the assigned platform. Target refraction is emmetropia in the dominant eye and approximately -0.50 D in the non-dominant eye. Participants and outcome assessors are masked to lens allocation until the 6-month primary endpoint assessment is complete; the operating surgeon cannot be masked.
The study compares monocular (eye-level) and binocular (patient-level) outcomes between the two platforms. The primary endpoint is the monocular distance-corrected defocus range at the 0.2 logMAR threshold, measured 6 months after surgery from a standardized defocus curve (4-meter ETDRS chart, defocus +1.0 D to -3.5 D in 0.5 D steps). Secondary assessments include visual acuity at multiple distances, the complete defocus curve, manifest refraction and astigmatic vector components, higher-order wavefront aberrations, rotational stability of the toric variants, patient-reported visual function and quality of vision (including halos, glare, and starbursts), spectacle independence, satisfaction, and surgical safety.
Assessments are performed preoperatively and at 1, 3, and 6 months postoperatively. The primary analysis compares the mean monocular defocus range between groups using one eye per patient (the first-operated eye), with sensitivity analyses using both eyes and appropriate adjustment for within-patient correlation. The study is regulated as a post-market clinical follow-up (PMCF) investigation under Article 74(1) of Regulation (EU) 2017/745; both lenses are CE-marked and used within their approved intended purpose.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 110 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Vienna Hospital Association is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Apr 2029, 32 months later.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 32 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Vienna Hospital Association