NCT07471295

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
19mo left

Started Jul 2026

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Feb 2028

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

March 10, 2026

Last Update Submit

July 21, 2026

Conditions

Cataract

Outcome Measures

Primary Outcomes (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

    From preoperative visit to the final postoperative visit at twelve months

Secondary Outcomes (16)

  • Refractive outcomes

    From preoperative visit to the final postoperative visit at twelve months

  • Refractive predictability

    From preoperative visit to the final postoperative visit at twelve months

  • Reduction in cylindrical power

    From preoperative visit to the final postoperative visit at twelve months

  • IOL Rotation

    From preoperative visit to the final postoperative visit at twelve months

  • Stability of IOL axis orientation

    Between 30 to 60 days and 120 to 180 days

  • +11 more secondary outcomes

Other Outcomes (8)

  • Preservation of Corrected Distance Visual Acuity

    12-Months Postoperatively

  • Contrast Sensitivity

    Six-Months Postoperatively

  • Posterior Capsule Opacification

    12-Months Postoperatively

  • +5 more other outcomes

Study Arms (1)

Unilateral or bilateral implantation of investigational device

EXPERIMENTAL
Device: Monofocal toric IOL

Interventions

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.

Unilateral or bilateral implantation of investigational device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Oční klinikaO

Prague, Prague, 18100, Czechia

RECRUITING

Oční Centrum Praha

Prague, Czechia

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

PVK Precise Vision GmbH

Rheine, 48429, Germany

NOT YET RECRUITING

Ofatlivist Alicante

Alicante, 03001, Spain

RECRUITING

Ayrshire Eye Clinic

Ayr, Ayrshire, KA7 2SP, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Gerd Auffarth, Dr. Med

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

  • Andrea Janeková, MD, Ph.D

    Eye Centre Prague

    PRINCIPAL INVESTIGATOR

  • Florian Kretz, MD

    PVK Precise Vision GmbH

    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

Central Study Contacts

Grant Sharpe

CONTACT

+447918937014grant.sharpe@zeiss.com

Linda Villanueva

CONTACT

7143226506linda.villanueva@zeiss.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

GB(1)DE(2)CZ(2)ES(1)