Trials / Completed
CompletedNCT06250855
Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens
At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 105 (actual)
- Sponsor
- SIFI SpA · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mini Toric IOL | 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. |
Timeline
- Start date
- 2024-04-24
- Primary completion
- 2024-10-27
- Completion
- 2024-10-27
- First posted
- 2024-02-09
- Last updated
- 2025-12-23
Locations
2 sites across 1 country: Romania
Source: ClinicalTrials.gov record NCT06250855. Inclusion in this directory is not an endorsement.