POST-MARKET, PROSPECTIVE EVALUATION OF LONG-TERM VISUAL OUTCOMES AND ROTATIONAL STABILITY OF AN ASPHERIC TORIC MONOFOCAL INTRAOCULAR LENS (MINI TORIC READY)

Observational prospective clinical investigation to assess the long-term effectiveness and safety of aspheric toric monofocal Mini Toric Ready (SIFI SpA, Italy) intraocular lens(IOL) after cataract surgery with a follow-up period up to twenty-four months.

Immunoeye SRL, Sfântu Gheorghe (Covasna), Romania; Gauss Clinic Bacau, Bacau, Romania.

50 patients (71 eyes) underwent cataract surgery with21 binocular and 29 monocular implantations of Mini Toric Ready. Inclusion criteria: Eyes with corneal astigmatism ≥0.75 D.Exclusion criteria considered: monocular patients, preoperative corneal astigmatism higher than 3 D., ocular diseases, ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions. All patients underwent one postoperative visit at least 12 months after surgery. Examinations included post-operative spherical equivalent (SE), corrected and uncorrected monocular and/or binocular distance visual acuity, Heidelberg Daily Task Evaluation (DATE) and Quality of Vision (QoV) questionnaires, far contrast sensitivity (CS) in scotopic condition, and incidence of adverse events (AE).

Mean refractive spherical equivalent and residual cylinder, at 12 months follow up, were -0.04 ± 0.81 D and -0.61 ±0.63 D, respectively. Monocular distance corrected (DCVA) and uncorrected (UDVA) visual acuities at 4 meters were 0.08 ± 0.11and 0.11 ± 0.12 logMAR respectively, whereas the mean binocular postoperative DCVA and UDVA were 0.01 ± 0.03 and 0.06 ± 0.16 logMAR. QoV and DATE questionnaires’ results showed excellent patient satisfaction and low incidence of visual disturbances. Binocular CS in scotopic conditions was high at most frequencies and within the normal values for each frequency. At 12 months follow-up, the IOL rotation was ≤ 5° in 65 eyes (91.6%). No adverse events were reported.

The long-term visual outcomes of Mini Toric Ready IOL demonstrated its effectiveness in reducing corneal astigmatism and improving visual quality at distance. Patients reported high satisfaction in terms of quality of vision and absence of disturbing symptoms. Moreover, Mini Toric Ready IOL remained rotationally stable throughout the postoperative period, and no adverse events were recorded following implantation.