Cataract1stQvsPureSeeNCT07688681
Prospective, Randomized, Parallel-group Comparison of Two Refractive EDOF Intraocular Lenses: Johnson & Johnson Tecnis PureSee Versus 1stQ Comfort Z-EDOF
A study testing Tecnis PureSee IOL implantation and 1stQ Comfort Z-EDOF IOL implantation in people with Cataract, run by Vienna Hospital Association at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Tecnis PureSee IOL implantation and 1stQ Comfort Z-EDOF IOL implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund
Vienna, State of Vienna, 1130
Michal Klimek, MD, +43 6504607496, klimek.michael@gmx.at
About this study
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.
Read the detailed description
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.
- Conditions
- Cataract
- Being tested
- Tecnis PureSee IOL implantation, 1stQ Comfort Z-EDOF IOL implantation
- Keywords
- EDOF intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis PureSee IOL implantationDevice
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 implantationDevice
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 group | Role | What they receive |
|---|---|---|
| Tecnis PureSee | Experimental | 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. Receives: Device: Tecnis PureSee IOL implantation |
| 1stQ Comfort Z-EDOF | Active comparator | 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. Receives: Device: 1stQ Comfort Z-EDOF IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Hospital Association
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prim. Univ.-Prof. Dr. Pia Veronika Vécsei-Marlovits, MSc, MB, Vienna Hospital Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688681
- Sponsor's protocol ID
- MA_15_EK_26_094_VK
- Acronym
- 1stQvsPureSee
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Parallel-group Comparison of Two Refractive EDOF Intraocular Lenses: Johnson & Johnson Tecnis PureSee Versus 1stQ Comfort Z-EDOF
- ClinicalTrials.gov ID
- NCT07688681
- Acronym / sponsor ID
- 1stQvsPureSee / MA_15_EK_26_094_VK
- Conditions
- Cataract
- Keywords
- EDOF intraocular lens
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Vienna Hospital AssociationOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis PureSee | Experimental | Device: Tecnis PureSee IOL implantationBilateral 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. |
| 1stQ Comfort Z-EDOF | Active comparator | Device: 1stQ Comfort Z-EDOF IOL implantationBilateral 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecnis PureSee IOL implantationPhacoemulsification 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 | Tecnis PureSee |
| 1stQ Comfort Z-EDOF IOL implantationPhacoemulsification 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. | Device | 1stQ Comfort Z-EDOF |
Primary outcome
Monocular distance-corrected defocus range (DCDR) at 0.2 logMAR
Time frame: 6 months after surgery
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).
1 secondary outcome
Monocular visual acuity at multiple distances
Time frame: 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecnis PureSee IOL implantation and 1stQ Comfort Z-EDOF IOL implantation in people with Cataract, run by Vienna Hospital Association at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Klimek, MD (+43 650 460 7496, klimek.michael@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular distance-corrected defocus range (DCDR) at 0.2 logMAR (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.