biostudies-literatureUnknown15Ramamurthy D<h4>Purpose</h4>To evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof^® IQ PanOptix^® (TFNT00), in an Indian population.<h4>Patients and methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.Clinical ophthalmology (Auckland, N.Z.)213-225https://www.ebi.ac.uk/biostudies/studies/S-EPMC7837564biostudies-literatureClinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population.PMC7837564Reddy JCDey ARamamurthy DPadmanabhan PShetty NVasavada ASudhir RRfalseClinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population.<h4>Purpose</h4>To evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof^® IQ PanOptix^® (TFNT00), in an Indian population.<h4>Patients and methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.2021-01-01T00:00:00Z20212025-04-26T20:08:58.117Z2025-04-06T16:20:21.188ZS-EPMC78375643351918310.2147/OPTH.S279001