Toric IOL performance and constants optimization after cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study evaluates a monofocal toric intraocular lens by focusing on safety and refractive outcomes to optimize IOL constants. Eligible adults with age-related cataract and regular corneal astigmatism will undergo cataract surgery with the investigational lens, and refractive results will guide adjustments in lens constants. The trial involves follow-up exams to assess visual acuity, refractive accuracy, and axis alignment postoperatively. Multisite participation includes centers in Prague and Heidelberg, sponsored by Carl Zeiss Meditec AG with targomedGmbH as a collaborator.

Why it matters

Who can join: the full rules

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

Where it's running

• Oční klinikaO
  Prague, Prague, Czechia Recruiting
• Oční Centrum Praha
  Prague, Czechia Recruiting
• Ofatlivist Alicante
  Alicante, Spain Recruiting
• Universitätsklinikum Heidelberg
  Heidelberg, Germany Not yet recruiting
• PVK Precise Vision GmbH
  Rheine, Germany Not yet recruiting
• Ayrshire Eye Clinic
  Ayr, Ayrshire, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Gerd Auffarth, Dr. Med — University Hospital Heidelberg
• Study coordinator: Grant Sharpe
• Email: grant.sharpe@zeiss.com
• Phone: +447918937014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.