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
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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.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 105 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Oct 2024, 6 months.
Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 6 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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