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NCT Number: NCT07471295

Toric Performance And Constant Evaluation

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oční klinikaO, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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;
  • 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

Treatment and study plan

Monofocal toric IOL

Device

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.

Primary outcomes

  1. Refractive predictability

    Time frame: From preoperative visit to the final postoperative visit at twelve months

    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

Secondary outcomes

  1. Refractive outcomes

    Time frame: From preoperative visit to the final postoperative visit at twelve months

    Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent

  2. Refractive predictability

    Time frame: From preoperative visit to the final postoperative visit at twelve months

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

  3. Reduction in cylindrical power

    Time frame: From preoperative visit to the final postoperative visit at twelve months

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

  4. IOL Rotation

    Time frame: From preoperative visit to the final postoperative visit at twelve months

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

  5. Stability of IOL axis orientation

    Time frame: Between 30 to 60 days and 120 to 180 days

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

  6. Axis Misalignment

    Time frame: From baseline to postoperative visit 120-180 days

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

  7. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 12-Month Postoperative

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

    Time frame: 12-Months Postoperatively

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

    Time frame: 12-Months Postoperatively

  10. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 12-Months Postoperatively

  11. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 12-Months Postoperatively

  12. Monocular (1st eye implantations) defocus curve

    Time frame: 12-Months Postoperatively

  13. Binocular defocus curve on subjects implanted binocularly

    Time frame: 12-Months Postoperatively

  14. Intraocular Pressure

    Time frame: 12-Months Postoperatively

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

    Time frame: 12-Months Postoperatively

  16. IOL observations

    Time frame: 12-Months Postoperatively

    IOL Decentration, Tilt, Discoloration, Opacity, Glistenings

Other outcomes

  1. Preservation of Corrected Distance Visual Acuity

    Time frame: 12-Months Postoperatively

    Rate of eyes with postoperative CDVA 0.3 logMAR or better

  2. Contrast Sensitivity

    Time frame: Six-Months Postoperatively

  3. Posterior Capsule Opacification

    Time frame: 12-Months Postoperatively

    Rate of occurrence and grading

  4. Rate of performed and planned Nd:YAG laser capsulotomies

    Time frame: 12-Months Postoperatively

  5. Signs of intraocular inflammation

    Time frame: 12-Months Postoperatively

    • Anterior chamber cells following Standardization of Uveitis Nomenclature (SUN) grading scheme
    • Anterior chamber flare following SUN grading scheme
    • Vitreous cells, following National Institutes of Health (NIH) grading scheme
    • Cystoid macular oedema
    • Hypopyon
    • Endophthalmitis
  6. Slit lamp biomicoscopy

    Time frame: 12-Months Postoperatively

    • Eyelid
    • Conjunctiva
    • Corneal Edema
    • Other corneal abnormalities
  7. Fundus examination

    Time frame: 12-Months Postoperatively

    • Retina
    • Macula
    • Optic Nerve
  8. Adverse event rate of Posterior Chamber IOL

    Time frame: 12-Months Postoperatively

    As per ISO 11979:2024

Study contacts

Contact information is provided by the study sponsor or research team.

Grant Sharpe

CONTACT

[email protected]

+447918937014

Linda Villanueva

CONTACT

[email protected]

7143226506

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Collaborators

  • targomedGmbH

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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