AzTrials
AzTrials

CataractPhase 4PACENCT07471295

Toric Performance And Constant Evaluation

A Phase 4 study testing Monofocal toric IOL in people with Cataract, run by Carl Zeiss Meditec AG at 6 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract
What is being tested?
Monofocal toric IOL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
6 sitesin 4 countries
Study dates
13 Jul 2026to 28 Feb 2028
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older;
  • Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;
  • Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery;
  • Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.
  • Signed informed consent form;
  • Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;
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  • Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);
  • Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;
  • Clear intraocular media other than cataract.

Who cannot join

  • Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;
  • Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye
  • Traumatic cataract;
  • Pregnancy or lactation;
  • Concurrent participation in another drug or device investigation within the last 30 days;
  • Irregular astigmatism;
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  • Instability of keratometry or biometry measurements;
  • Subjects wearing contact lenses as standard vision aid;
  • Abnormal pupil;
  • Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);
  • History of concurrent intraocular inflammation;
  • Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);
  • History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis;
  • Pseudoexfoliation syndrome (according to investigator judgement);
  • Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
  • All kind of infections (acute ocular disease, external / internal infection, systemic infection);
  • Monophthalmic patient;
  • Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease
  • Patient expected to require retinal laser treatment before the end of the last follow-up examination;
  • Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination;
  • Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)
  • In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day

Trial locations and contacts

6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Grant Sharpe contact

+447918937014

grant.sharpe@zeiss.com

Linda Villanueva contact

7143226506

linda.villanueva@zeiss.com

6 sites in 4 countries

Czechia2 sites, 2 recruiting

  • Oční klinikaO

    Prague, Prague, 18100

    Petra Kasakova, +420734579078, kasakova@premiumclinic.cz

    Jiří Pašta

    Recruiting

  • Oční Centrum Praha

    Prague

    Study Coordinator

    Andrea Janeková

    Recruiting

Other trials in Czechia

Germany2 sites, 2 recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

    Raquel Amroussi, +4966215636849, raquel.willrichamroussi@med.uni-heidelberg.de

    Gerd Auffarth

    Not yet recruiting

  • PVK Precise Vision GmbH

    Rheine, 48429

    Study Coordinator, +49 800 3 100 900, a.gerling@precise.vision

    Florian Kretz, MD

    Not yet recruiting

Other trials in Germany

Spain1 site, 1 recruiting

  • Ofatlivist Alicante

    Alicante, 03001

    José Rubio, jmrubio@oftalvist.es

    Pedro Tañá

    Recruiting

Other trials in Spain

United Kingdom1 site, 1 recruiting

  • Ayrshire Eye Clinic

    Ayr, Ayrshire, KA7 2SP

    Study Coordinator, +44 1292 282100, info@ayrshireeyeclinic.com

    Satish Srinivasan

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation

The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.

Conditions
Cataract
Being tested
Monofocal toric IOL
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monofocal toric IOLDevice

    The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism.

Study groups in NCT07471295
Study groupRoleWhat they receive
Unilateral or bilateral implantation of investigational deviceExperimentalNot described
Receives: Device: Monofocal toric IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Refractive predictability

    Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D

    Measured: From preoperative visit to the final postoperative visit at twelve months

Secondary outcomes (16)

  1. Refractive outcomes

    Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent

    Measured: From preoperative visit to the final postoperative visit at twelve months

  2. Refractive predictability

    Percentage of eyes within ± 0.25 D, ± 0.5 D, \& ± 1.0 D

    Measured: From preoperative visit to the final postoperative visit at twelve months

  3. Reduction in cylindrical power

    The change in manifest refractive cylinder from baseline to the final postoperative visit.

    Measured: From preoperative visit to the final postoperative visit at twelve months

  4. IOL Rotation

    Percentage of IOLs with IOL rotation with less than 10 and 20 degrees.

    Measured: From preoperative visit to the final postoperative visit at twelve months

  5. Stability of IOL axis orientation

    Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively

    Measured: Between 30 to 60 days and 120 to 180 days

  6. Axis Misalignment

    The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees.

    Measured: From baseline to postoperative visit 120-180 days

  7. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Measured: 12-Month Postoperative

  8. Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better

    Measured: 12-Months Postoperatively

  9. Monocular Best-Corrected Distance Visual Acuity (CDVA)

    Measured: 12-Months Postoperatively

  10. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    Measured: 12-Months Postoperatively

  11. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Measured: 12-Months Postoperatively

  12. Monocular (1st eye implantations) defocus curve

    Measured: 12-Months Postoperatively

  13. Binocular defocus curve on subjects implanted binocularly

    Measured: 12-Months Postoperatively

  14. Intraocular Pressure

    Measured: 12-Months Postoperatively

  15. Assessment of subject satisfaction, patient reported outcomes, and spectacle independence

    Measured: 12-Months Postoperatively

  16. IOL observations

    IOL Decentration, Tilt, Discoloration, Opacity, Glistenings

    Measured: 12-Months Postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start13 Jul 2026
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07471295
Sponsor's protocol ID
GPAS-SAS-026-01
Acronym
PACE
Status last verified
Jul 2026
First submitted
10 Mar 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Monofocal toric IOL in people with Cataract, run by Carl Zeiss Meditec AG at 6 sites in 4 countries.

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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 22 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 6 sites in Czechia, Germany, Spain, United Kingdom. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Grant Sharpe (+447918937014, grant.sharpe@zeiss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Refractive predictability (time frame: From preoperative visit to the final postoperative visit at twelve months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07471295.

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 22 Jul 2026.

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