Toric Performance And Constant Evaluation

Sponsor
Carl Zeiss Meditec AG
Study ID
NCT07471295
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
Jul 13, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unilateral or bilateral implantation of investigational device

Primary Outcome Measure

Refractive predictability [ Time Frame: From preoperative visit to the final postoperative visit at twelve months ]

Central Contacts

Related Studies