PMID- 37296411
OWN - NLM
STAT- MEDLINE
DCOM- 20230612
LR  - 20230612
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 24
IP  - 1
DP  - 2023 Jun 9
TI  - Safety and efficacy in pediatric secondary intraocular lens implantation, 
      in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized 
      controlled trial.
PG  - 388
LID - 10.1186/s13063-023-07411-z [doi]
LID - 388
AB  - BACKGROUND: Treatment of pediatric cataract remains challenging because of the 
      extremely high incidence of postoperative adverse events (AEs), especially the 
      AEs related to the locations of secondary implanted intraocular lens (IOL). There 
      are two common locations for secondary IOL implantation in pediatric aphakic 
      eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no 
      large, prospective studies comparing complication rates and visual prognosis of 
      in-the-bag versus ciliarysulcus secondary IOL implantation in pediatric patients. 
      Whether or how much secondary in-the-bag IOL implantation benefits the pediatric 
      patients more than sulcus implantation and deserves to be performed routinely by 
      surgeons remains to be elucidated. Here, we describe the protocol of a randomized 
      controlled trial (RCT) designed to evaluate the safety and efficacy of two 
      approaches of IOL implantation in pediatric aphakia. METHODS: The study is a 
      multicenter, single-blinded RCT with 10 years of follow-up. Overall, a minimum of 
      286 eyes (approximately 228 participants assuming 75% have two study eyes) will 
      be recruited. This study will be carried out in four eye clinics across China. 
      Consecutive eligible patients are randomized to undergo either secondary 
      in-the-bag IOL implantation or secondary sulcus IOL implantation. Participants 
      with two eyes eligible will receive the same treatment. The primary outcomes are 
      IOL decentration and the incidence of glaucoma-related AEs. The secondary 
      outcomes include the incidence of other AEs, IOL tilt, visual acuity, and ocular 
      refractive power. Analysis of the primary and secondary outcomes is to be based 
      on the intention-to-treat and per-protocol analysis. Statistical analyses will 
      include the chi(2) test or Fisher's exact test for the primary outcome, mixed model 
      and generalized estimated equation (GEE) model for the secondary outcome, 
      Kaplan-Meier survival curves for the cumulative probability of glaucoma-related 
      AEs over time in each group. DISCUSSION: To the best of our knowledge, this study 
      is the first RCT to evaluate the safety and efficacy of secondary IOL 
      implantation in pediatric aphakia. The results will provide high-quality evidence 
      for the clinical guidelines for the treatment of pediatric aphakia. TRIAL 
      REGISTRATION: ClinicalTrials.gov NCT05136950. Registered on 1 November 2021.
CI  - (c) 2023. The Author(s).
FAU - Zou, Yingshi
AU  - Zou Y
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China.
FAU - Jin, Ling
AU  - Jin L
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China.
FAU - Qu, Bo
AU  - Qu B
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China.
FAU - Chen, Hui
AU  - Chen H
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China.
FAU - Zeng, Mingbing
AU  - Zeng M
AD  - Hainan Eye Hospital, Zhongshan Ophthalmic Center, Sun Yat-Sen University Haikou, 
      Hainan, China.
FAU - Li, Xia
AU  - Li X
AD  - The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 
      China.
FAU - Liu, Xinhua
AU  - Liu X
AD  - Shenzhen Eye Institute, Shenzhen Eye Hospital, Jinan University, Shenzhen, China.
FAU - Luo, Lixia
AU  - Luo L
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China.
FAU - Liu, Zhenzhen
AU  - Liu Z
AUID- ORCID: 0000-0002-4853-2474
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China. liuzhenzhen@gzzoc.com.
FAU - Liu, Yizhi
AU  - Liu Y
AD  - State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong 
      Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong 
      Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, 
      7# Jinsui Road, Guangzhou, 510000, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT05136950
GR  - 81873675/the National Social Science Foundation of China/
GR  - 303020102/the Construction Project of High-Level Hospitals in Guangdong Province/
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20230609
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Child
MH  - Humans
MH  - Lens Implantation, Intraocular/adverse effects/methods
MH  - *Aphakia, Postcataract/etiology/surgery
MH  - Visual Acuity
MH  - *Cataract/complications
MH  - *Glaucoma
MH  - Retrospective Studies
MH  - Postoperative Complications/etiology/surgery
PMC - PMC10251574
OTO - NOTNLM
OT  - Adverse events
OT  - Glaucomarelated
OT  - In-the-bag IOL implantation
OT  - Pediatric aphakia
OT  - Secondary intraocular lens implantation
OT  - Sulcus IOL implantation
COIS- The authors declare that they have no competing interests.
EDAT- 2023/06/10 15:13
MHDA- 2023/06/12 06:42
PMCR- 2023/06/09
CRDT- 2023/06/09 23:34
PHST- 2022/04/21 00:00 [received]
PHST- 2023/05/24 00:00 [accepted]
PHST- 2023/06/12 06:42 [medline]
PHST- 2023/06/10 15:13 [pubmed]
PHST- 2023/06/09 23:34 [entrez]
PHST- 2023/06/09 00:00 [pmc-release]
AID - 10.1186/s13063-023-07411-z [pii]
AID - 7411 [pii]
AID - 10.1186/s13063-023-07411-z [doi]
PST - epublish
SO  - Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z.