NCT07471295 Toric Performance And Constant Evaluation
| NCT ID | NCT07471295 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Carl Zeiss Meditec AG |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-07-13 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 130 participants in total. It began in 2026-07-13 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Gerd Auffarth, Dr. Med
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT07471295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07471295 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07471295 currently recruiting?
Yes, NCT07471295 is actively recruiting participants. Contact the research team at grant.sharpe@zeiss.com for enrollment information.
Where is the NCT07471295 trial being conducted?
This trial is being conducted at Prague, Czechia, Prague, Czechia, Heidelberg, Germany, Rheine, Germany and 2 additional locations.
Who is sponsoring the NCT07471295 clinical trial?
NCT07471295 is sponsored by Carl Zeiss Meditec AG. The principal investigator is Gerd Auffarth, Dr. Med at University Hospital Heidelberg. The trial plans to enroll 130 participants.