| Popis: |
Dandapani Ramamurthy,1 Abhay Vasavada,2 Prema Padmanabhan,3 Jagadesh C Reddy,4 Naren Shetty,5 Arindam Dey,6 Rachapalle Reddi Sudhir3 1The Eye Foundation, Coimbatore, Tamil Nadu, India; 2Raghudeep Eye Hospital, Ahmedabad, Gujarat, India; 3Medical Research Foundation, Chennai, Tamil Nadu, India; 4LV Prasad Eye Institute, Hyderabad, Telangana, India; 5Narayana Nethralaya Eye Hospital, Rajajinagar, Bangalore, India; 6Alcon Laboratories (India) Private Ltd, Bangalore, IndiaCorrespondence: Dandapani RamamurthyThe Eye Foundation, Diwan Bahadur Road, Coimbatore, Tamil Nadu 641002, IndiaTel +91 422 4242000Email drramamurthy@theeyefoundation.inPurpose: To evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof® IQ PanOptix® (TFNT00), in an Indian population.Patients and Methods: This prospective, multicenter, observational, single-arm, post-marketing study included 67 patients undergoing cataract surgery with bilateral implantation of TFNT00 across five Indian sites. Postoperative outcomes were assessed at 3 months after second eye surgery. Effectiveness outcomes included: mean binocular and monocular visual acuity (VA) at distance (4 m), intermediate (60 cm), and near (40 cm); binocular defocus curve; manifest refraction; and subjective symptom questionnaire evaluation. Safety outcomes included the rate of ocular adverse events and mesopic contrast sensitivity.Results: Mean binocular and monocular distance-corrected and uncorrected VAs of 0.1 logMAR or better (approximately 20/25 Snellen) were achieved at distance, intermediate, and near. Overall, ≥ 70% of patients achieved binocular 0.1 logMAR vision or better across all distances. TFNT00 maintained a mean VA of 0.1 logMAR or better at the defocus range of +0.5 diopters (D) to – 2.5 D (200 cm to 40 cm). The subjective symptom questionnaire-assessed frequency of halo visual disturbances was low at Month 3; halos were reported “none of the time” to “only some of the time” in 86.6% of patients. The large majority of patients (98.5%) were “satisfied” or “very satisfied” with their near, intermediate, and distance vision at Month 3, and ≥ 94.0% of patients reported spectacle independence for tasks at all distances. The adverse event rate was low; no patients discontinued due to an adverse event.Conclusion: TFNT00 provided a continuous range of vision of 20/25 or better for distance to near and performed effectively at an intermediate functional distance of 60 cm, resulting in high levels of spectacle independence and patient satisfaction. TFNT00 demonstrated a good safety profile and a low post-operative frequency of halo visual disturbances.Keywords: PanOptix, multifocal, cataract surgery, non-apodized, intraocular lens, IOL |
