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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Refractive predictability
Timeframe: From preoperative visit to the final postoperative visit at twelve months