PMID- 36561374
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221224
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 16
DP  - 2022
TI  - Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using 
      a Preloaded Automated Injector in an Indian Population.
PG  - 4215-4225
LID - 10.2147/OPTH.S379054 [doi]
AB  - PURPOSE: To assess real-world clinical outcomes and safety of the Clareon((R)) 
      intraocular lens (IOL) and AutonoMe((R)) 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.
CI  - (c) 2022 Titiyal et al.
FAU - Titiyal, Jeewan S
AU  - Titiyal JS
AD  - Department of Cornea and Refractive Surgery, All India Institute of Medical 
      Sciences, New Delhi, India.
FAU - Basak, Samar K
AU  - Basak SK
AD  - Department of Cornea and Cataract Services, Disha Eye Hospitals, Kolkata, India.
FAU - Shetty, Naren
AU  - Shetty N
AD  - Department of Cataract and Refractive Services, Narayana Nethralaya, Bengaluru, 
      India.
FAU - Mathur, Umang
AU  - Mathur U
AD  - Department of Ophthalmology, Dr. Shroff's Charity Eye Hospital, New Delhi, India.
FAU - Padmanabhan, Prema
AU  - Padmanabhan P
AUID- ORCID: 0000-0001-7248-9907
AD  - Department of Ophthalmology, Sankara Nethralaya, Chennai, India.
FAU - Ganesh, Sri
AU  - Ganesh S
AUID- ORCID: 0000-0002-2852-758X
AD  - Department of Phaco and Refractive Surgery, Nethradhama Superspeciality Eye 
      Hospital, Bengaluru, India.
FAU - Dey, Arindam
AU  - Dey A
AD  - Alcon Laboratories (India) Private Ltd, Bengaluru, India.
FAU - Ramamurthy, Dandapani
AU  - Ramamurthy D
AD  - Department of Cornea, Cataract and Refractive Services, The Eye Foundation, 
      Coimbatore, India.
LA  - eng
PT  - Case Reports
PT  - Clinical Trial
DEP - 20221216
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC9767064
OTO - NOTNLM
OT  - glistenings
OT  - posterior capsular opacification
OT  - visual acuity
COIS- JS Titiyal, SK Basak, S Ganesh, P Padmanabhan, N Shetty, and U Mathur have no 
      conflict of interest to disclose. A Dey is an employee of Alcon. D Ramamurthy is 
      a consultant to Alcon.
EDAT- 2022/12/24 06:00
MHDA- 2022/12/24 06:01
PMCR- 2022/12/16
CRDT- 2022/12/23 02:24
PHST- 2022/06/25 00:00 [received]
PHST- 2022/11/08 00:00 [accepted]
PHST- 2022/12/23 02:24 [entrez]
PHST- 2022/12/24 06:00 [pubmed]
PHST- 2022/12/24 06:01 [medline]
PHST- 2022/12/16 00:00 [pmc-release]
AID - 379054 [pii]
AID - 10.2147/OPTH.S379054 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2022 Dec 16;16:4215-4225. doi: 10.2147/OPTH.S379054. eCollection 
      2022.