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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini Toric IOL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 12 to 24 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Stability | Intraocular Lens (IOL) Rotation Stability | From 12 to 24 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety profile: Adverse Events (AEs) | Incidence of Adverse events such as Posterior Capsular Opacification (PCO) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gauss Clinic Bacau | Bacau | 600269 | Romania | |||
| Immunoeye SRL |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| From 12 to 24 months post-surgery |
| Sfantu Gheorghe |
| 520024 |
| Romania |