Clinical trial NCT05136950: Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation
Official title: Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lens Implantation, Intraocular
Keywords: Pediatric aphakia
Secondary Intraocular Lens Implantation
Glaucoma-related Adverse Events
In-the-bag IOL implantation
Sulcus IOL fixation
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Incidence of glaucoma-related adverse events
timeFrame: One year after surgery
Secondary outcomes:
measure: Incidence of glaucoma-related adverse events
timeFrame: Six months,three years, five years, ten years after surgery
measure: Visual acuity
timeFrame: Six months,one year, three years, five years, ten years after surgery
measure: Ocular refractive power
timeFrame: Six months,one year,three years, five years, ten years after surgery
measure: Intraocular lens decentration
timeFrame: Six months,one year, three years, five years, ten years after surgery
measure: Intraocular lens tilt
timeFrame: Six months,one year, three years, five years, ten years after surgery
measure: Incidence of other adverse events
timeFrame: Six months,one year, three years, five years, ten years after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060
Study officials:
affiliation: Zhongshan Ophthalmic center, Guangzhou, People's Republic of China
name: Yizhi Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.