Toric Performance And Constant Evaluation
ConditionCataract
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarl Zeiss Meditec AG
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Monofocal toric IOL
Treatment groups
130 Participants
are divided into 1 treatment groupSponsors and collaborators
Carl Zeiss Meditec AG
Lead sponsor
targomedGmbH
Collaborator
Source ClinicalTrials.gov