Clinical Ophthalmology (Dec 2022)

Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population

  • Titiyal JS,
  • Basak SK,
  • Shetty N,
  • Mathur U,
  • Padmanabhan P,
  • Ganesh S,
  • Dey A,
  • Ramamurthy D

Journal volume & issue
Vol. Volume 16
pp. 4215 – 4225

Abstract

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Jeewan S Titiyal,1 Samar K Basak,2 Naren Shetty,3 Umang Mathur,4 Prema Padmanabhan,5 Sri Ganesh,6 Arindam Dey,7 Dandapani Ramamurthy8 1Department of Cornea and Refractive Surgery, All India Institute of Medical Sciences, New Delhi, India; 2Department of Cornea and Cataract Services, Disha Eye Hospitals, Kolkata, India; 3Department of Cataract and Refractive Services, Narayana Nethralaya, Bengaluru, India; 4Department of Ophthalmology, Dr. Shroff’s Charity Eye Hospital, New Delhi, India; 5Department of Ophthalmology, Sankara Nethralaya, Chennai, India; 6Department of Phaco and Refractive Surgery, Nethradhama Superspeciality Eye Hospital, Bengaluru, India; 7Alcon Laboratories (India) Private Ltd, Bengaluru, India; 8Department of Cornea, Cataract and Refractive Services, The Eye Foundation, Coimbatore, IndiaCorrespondence: Jeewan S Titiyal, Department of Cornea and Refractive Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India, Email [email protected]: To assess real-world clinical outcomes and safety of the Clareon® intraocular lens (IOL) and AutonoMe® automated preloaded delivery system in an Indian population.Patients and methods: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥ 20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons’ satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs).Results: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53± 0.44 logMAR preoperatively to 0.00± 0.08 logMAR at week 1 and − 0.03± 0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78± 0.40 logMAR preoperatively, 0.11± 0.15 logMAR at week 1, and 0.08± 0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported.Conclusion: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.Keywords: glistenings, posterior capsular opacification, visual acuity

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