An observational study in Cataract and Astigmatism, sponsored by SIFI SpA. Completed at 2 sites in Romania. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by SIFI SpA · Observational
Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.
Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.
Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation. Subjects enrolled in the investigation underwent cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.
Exclusion Criteria:
Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation after cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.
Evaluation of the Visual Performance
Evaluate Mini Toric Ready Intraocular Lens (IOL) performance in terms of correction of spherical and cylindrical visual defects, corrected and uncorrected monocular and/or binocular distance visual acuity at least 12 months post implant.
Time frame: From 12 to 24 months post-surgery
Evaluation of the Stability
Intraocular Lens (IOL) Rotation Stability
Time frame: From 12 to 24 months post-surgery
Evaluation of the safety profile: Adverse Events (AEs)
Incidence of Adverse events such as Posterior Capsular Opacification (PCO)
Time frame: From 12 to 24 months post-surgery
Evaluation of the safety profile
Rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL after at least 12 months post implant.
Time frame: From 12 to 24 months post-surgery
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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SIFI SpA