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Recruiting NCT05136950

Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation

No phase Interventional Lens Implantation, Intraocular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secondary in-the-bag IOL fixation, Secondary ciliary sulcus IOL fixation.
Who it may be relevant to
Registry conditions: Lens Implantation, Intraocular. Basic parameters: 18 months — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial

Overview

To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia

Detailed description

Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.

Interventions

  • Procedure Secondary in-the-bag IOL fixation
    The experimental group with secondary IOL fixated in the capsular bag
  • Procedure Secondary ciliary sulcus IOL fixation
    The control group with secondary IOL fixated in the ciliary sulcus

Primary outcome measures

  • Incidence of glaucoma-related adverse events [Time frame: One year after surgery]
Secondary outcome measures (6)
  • Incidence of glaucoma-related adverse events [Time frame: Six months,three years, five years, ten years after surgery]
  • Visual acuity [Time frame: Six months,one year, three years, five years, ten years after surgery]
  • Ocular refractive power [Time frame: Six months,one year,three years, five years, ten years after surgery]
  • Intraocular lens decentration [Time frame: Six months,one year, three years, five years, ten years after surgery]
  • Intraocular lens tilt [Time frame: Six months,one year, three years, five years, ten years after surgery]
  • Incidence of other adverse events [Time frame: Six months,one year, three years, five years, ten years after surgery]

Eligibility criteria

Inclusion criteria

  • Aged between 18 months and 14 years
  • Had a primary diagnosis of congenital cataract.
  • Underwent cataract extraction between the ages of 2 and 24 months

Exclusion criteria

  • Primary IOL implantation
  • Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma)
  • Suture fixation for secondary IOL implantation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060 — Guangzhou

Publications

  • Liu Z, Lin H, Jin G, Tan X, Qu B, Jin L, Chen X, Wang W, Han X, Xu J, Ying G, Han Y, He M, Congdon N, Chen W, Luo L, Liu Y. In-the-Bag Versus Ciliary Sulcus Secondary Intraocular Lens Implantation for Pediatric Aphakia: A Prospective Comparative Study. Am J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13. PMID 34653355
  • Wood KS, Tadros D, Trivedi RH, Wilson ME. Secondary intraocular lens implantation following infantile cataract surgery: intraoperative indications, postoperative outcomes. Eye (Lond). 2016 Sep;30(9):1182-6. doi: 10.1038/eye.2016.131. Epub 2016 Jul 1. PMID 27367747
  • Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664. PMID 33331850
  • Shenoy BH, Mittal V, Gupta A, Sachdeva V, Kekunnaya R. Complications and visual outcomes after secondary intraocular lens implantation in children. Am J Ophthalmol. 2015 Apr;159(4):720-6. doi: 10.1016/j.ajo.2015.01.002. Epub 2015 Jan 9. PMID 25579641
  • Zhao YE, Gong XH, Zhu XN, Li HM, Tu MJ, Coursey TG, Pflugfelder SC, Gu F, Chen D. Long-term outcomes of ciliary sulcus versus capsular bag fixation of intraocular lenses in children: An ultrasound biomicroscopy study. PLoS One. 2017 Mar 16;12(3):e0172979. doi: 10.1371/journal.pone.0172979. eCollection 2017. PMID 28301497
  • Whitman MC, Vanderveen DK. Complications of pediatric cataract surgery. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):414-20. doi: 10.3109/08820538.2014.959192. PMID 25325868
  • Zou Y, Jin L, Qu B, Chen H, Zeng M, Li X, Liu X, Luo L, Liu Z, Liu Y. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial. Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z. PMID 37296411

Identifiers

NCT: NCT05136950 · 2021KYPJ135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗