A Phase 4 interventional study of Monofocal toric IOL in Cataract, sponsored by Carl Zeiss Meditec AG. Recruiting at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Carl Zeiss Meditec AG · Phase 4, Interventional, and Treatment
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 130 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Carl Zeiss Meditec AG is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: From preoperative visit to the final postoperative visit at twelve months
Refractive outcomes
Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent
Time frame: From preoperative visit to the final postoperative visit at twelve months
Refractive predictability
Percentage of eyes within ± 0.25 D, ± 0.5 D, \& ± 1.0 D
Time frame: From preoperative visit to the final postoperative visit at twelve months
Reduction in cylindrical power
The change in manifest refractive cylinder from baseline to the final postoperative visit.
Time frame: From preoperative visit to the final postoperative visit at twelve months
IOL Rotation
Percentage of IOLs with IOL rotation with less than 10 and 20 degrees.
Time frame: From preoperative visit to the final postoperative visit at twelve months
Stability of IOL axis orientation
Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively
Time frame: Between 30 to 60 days and 120 to 180 days
Axis Misalignment
The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees.
Time frame: From baseline to postoperative visit 120-180 days
Monocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 12-Month Postoperative
Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better
Time frame: 12-Months Postoperatively
Monocular Best-Corrected Distance Visual Acuity (CDVA)
Time frame: 12-Months Postoperatively
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 12-Months Postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 12-Months Postoperatively
Monocular (1st eye implantations) defocus curve
Time frame: 12-Months Postoperatively
Binocular defocus curve on subjects implanted binocularly
Time frame: 12-Months Postoperatively
Intraocular Pressure
Time frame: 12-Months Postoperatively
Assessment of subject satisfaction, patient reported outcomes, and spectacle independence
Time frame: 12-Months Postoperatively
IOL observations
IOL Decentration, Tilt, Discoloration, Opacity, Glistenings
Time frame: 12-Months Postoperatively
Preservation of Corrected Distance Visual Acuity
Rate of eyes with postoperative CDVA 0.3 logMAR or better
Time frame: 12-Months Postoperatively
Contrast Sensitivity
Time frame: Six-Months Postoperatively
Posterior Capsule Opacification
Rate of occurrence and grading
Time frame: 12-Months Postoperatively
Rate of performed and planned Nd:YAG laser capsulotomies
Time frame: 12-Months Postoperatively
Signs of intraocular inflammation
* 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
Time frame: 12-Months Postoperatively
Slit lamp biomicoscopy
* Eyelid * Conjunctiva * Corneal Edema * Other corneal abnormalities
Time frame: 12-Months Postoperatively
Fundus examination
* Retina * Macula * Optic Nerve
Time frame: 12-Months Postoperatively
Adverse event rate of Posterior Chamber IOL
As per ISO 11979:2024
Time frame: 12-Months Postoperatively
Plan to share: Undecided
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