Astigmatism, Cataract
Conditions
Keywords
Cataract, Astigmatism, Monofocal IOL, Toric IOL
Brief 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.
Interventions
DEVICEMini 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.
Sponsors
SIFI SpA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts; * Preoperative total corneal astigmatism ≥0.75D; * Unilateral or bilateral cataract removal by phacoemulsification; * Clear intraocular media other than cataract; * Willing and able to complete all required postoperative visits; * Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.
Exclusion criteria
* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Visual Performance | From 12 to 24 months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Stability | From 12 to 24 months post-surgery | Intraocular Lens (IOL) Rotation Stability |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the safety profile: Adverse Events (AEs) | From 12 to 24 months post-surgery | Incidence of Adverse events such as Posterior Capsular Opacification (PCO) |
| Evaluation of the safety profile | From 12 to 24 months post-surgery | Rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL after at least 12 months post implant. |
Countries
Romania
Outcome results
None listed