Toric Performance And Constant Evaluation

ConditionCataract

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Monofocal toric IOL
Device
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.

Treatment groups

130 Participants

are divided into 1 treatment group

Group A: Unilateral or bilateral implantation of investigational deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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