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

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 P...

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Autores principales: Ramamurthy D, Vasavada A, Padmanabhan P, Reddy JC, Shetty N, Dey A, Sudhir RR
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Lenguaje:EN
Publicado: Dove Medical Press 2021
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spelling oai:doaj.org-article:4623295dd8ca4295814e1305801633a52021-12-02T10:55:25ZClinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population1177-5483https://doaj.org/article/4623295dd8ca4295814e1305801633a52021-01-01T00:00:00Zhttps://www.dovepress.com/clinical-outcomes-after-bilateral-implantation-of-a-trifocal-presbyopi-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Dandapani 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, IOLRamamurthy DVasavada APadmanabhan PReddy JCShetty NDey ASudhir RRDove Medical Pressarticlepanoptixmultifocalcataract surgerynon-apodizedintraocular lensiolOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 213-225 (2021)
institution DOAJ
collection DOAJ
language EN
topic panoptix
multifocal
cataract surgery
non-apodized
intraocular lens
iol
Ophthalmology
RE1-994
spellingShingle panoptix
multifocal
cataract surgery
non-apodized
intraocular lens
iol
Ophthalmology
RE1-994
Ramamurthy D
Vasavada A
Padmanabhan P
Reddy JC
Shetty N
Dey A
Sudhir RR
Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population
description 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
format article
author Ramamurthy D
Vasavada A
Padmanabhan P
Reddy JC
Shetty N
Dey A
Sudhir RR
author_facet Ramamurthy D
Vasavada A
Padmanabhan P
Reddy JC
Shetty N
Dey A
Sudhir RR
author_sort Ramamurthy D
title Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population
title_short Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population
title_full Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population
title_fullStr Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population
title_full_unstemmed Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population
title_sort clinical outcomes after bilateral implantation of a trifocal presbyopia-correcting intraocular lens in an indian population
publisher Dove Medical Press
publishDate 2021
url https://doaj.org/article/4623295dd8ca4295814e1305801633a5
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