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Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population

Authors Ramamurthy D, Vasavada A, Padmanabhan P, Reddy JC, Shetty N, Dey A, Sudhir RR

Received 27 August 2020

Accepted for publication 15 November 2020

Published 22 January 2021 Volume 2021:15 Pages 213—225

DOI https://doi.org/10.2147/OPTH.S279001

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Scott Fraser


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, India

Correspondence: Dandapani Ramamurthy
The Eye Foundation, Diwan Bahadur Road, Coimbatore, Tamil Nadu 641002, India
Tel +91 422 4242000
Email drramamurthy@theeyefoundation.in

Purpose: 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

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