Toric Performance And Constant Evaluation (PACE)

July 21, 2026 updated by: Carl Zeiss Meditec AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia
        • Recruiting
        • Oční Centrum Praha
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Andrea Janeková
    • Prague
      • Prague, Prague, Czechia, 18100
        • Recruiting
        • Oční klinikaO
        • Contact:
        • Principal Investigator:
          • Jiří Pašta
  • Germany
      • Heidelberg, Germany, 69120
      • Rheine, Germany, 48429
        • Not yet recruiting
        • PVK Precise Vision GmbH
        • Contact:
        • Contact:
          • Florian Kretz, MD
  • Spain
      • Alicante, Spain, 03001
        • Recruiting
        • Ofatlivist Alicante
        • Contact:
        • Principal Investigator:
          • Pedro Tañá
  • United Kingdom
    • Ayrshire
      • Ayr, Ayrshire, United Kingdom, KA7 2SP
        • Not yet recruiting
        • Ayrshire Eye Clinic
        • Contact:
        • Principal Investigator:
          • Satish Srinivasan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Unilateral or bilateral implantation of investigational device
Device: Monofocal toric IOL
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From preoperative visit to the final postoperative visit at twelve months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Refractive outcomes
Time Frame: From preoperative visit to the final postoperative visit at twelve months
Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent
From preoperative visit to the final postoperative visit at twelve months
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
From preoperative visit to the final postoperative visit at twelve months
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.
From preoperative visit to the final postoperative visit at twelve months
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.
From preoperative visit to the final postoperative visit at twelve months
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
Between 30 to 60 days and 120 to 180 days
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.
From baseline to postoperative visit 120-180 days
Monocular Uncorrected Distance Visual Acuity (UDVA)
Time Frame: 12-Month Postoperative
12-Month Postoperative
Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Monocular Best-Corrected Distance Visual Acuity (CDVA)
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Monocular (1st eye implantations) defocus curve
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Binocular defocus curve on subjects implanted binocularly
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Intraocular Pressure
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
Assessment of subject satisfaction, patient reported outcomes, and spectacle independence
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
IOL observations
Time Frame: 12-Months Postoperatively
IOL Decentration, Tilt, Discoloration, Opacity, Glistenings
12-Months Postoperatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preservation of Corrected Distance Visual Acuity
Time Frame: 12-Months Postoperatively
Rate of eyes with postoperative CDVA 0.3 logMAR or better
12-Months Postoperatively
Contrast Sensitivity
Time Frame: Six-Months Postoperatively
Six-Months Postoperatively
Posterior Capsule Opacification
Time Frame: 12-Months Postoperatively
Rate of occurrence and grading
12-Months Postoperatively
Rate of performed and planned Nd:YAG laser capsulotomies
Time Frame: 12-Months Postoperatively
12-Months Postoperatively
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
12-Months Postoperatively
Slit lamp biomicoscopy
Time Frame: 12-Months Postoperatively
  • Eyelid
  • Conjunctiva
  • Corneal Edema
  • Other corneal abnormalities
12-Months Postoperatively
Fundus examination
Time Frame: 12-Months Postoperatively
  • Retina
  • Macula
  • Optic Nerve
12-Months Postoperatively
Adverse event rate of Posterior Chamber IOL
Time Frame: 12-Months Postoperatively
As per ISO 11979:2024
12-Months Postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carl Zeiss Meditec AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
targomedGmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gerd Auffarth, Dr. Med, University Hospital Heidelberg
  • Principal Investigator: Andrea Janeková, MD, Ph.D, Eye Centre Prague
  • Principal Investigator: Jiří Pašta, Doc.MUDr, Premium Clinic
  • Principal Investigator: Satish Srinivasan, M.D, Ayrshire Eye Clinic
  • Principal Investigator: Pedro Tañá, M.D, Oftalmología Vistahermosa S.L
  • Principal Investigator: Florian Kretz, MD, PVK Precise Vision GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GPAS-SAS-026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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