Clinical trial NCT04803097: Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation
Official title: Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Capsular Contracture, Implant
Pediatric Cataract
Keywords: capsular outcome
pediatric cataract
posterior capsulorhexis
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients （age：0.5\~8.0 years）with congenital cataract

Brief summary: Lens capsular often changes after pediatric cataract surgery，causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.

Detailed description: To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.

Eligibility criteria: Inclusion Criteria:

Children (age 0.5\~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.

Exclusion Criteria:

Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.

Primary outcomes:
measure: PCOA
timeFrame: 20.74 ± 7.89 months
measure: VATA
timeFrame: 20.74 ± 7.89 months
Secondary outcomes:
measure: axial length growth
timeFrame: 20.74 ± 7.89 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
References:
citation: Lin H, Tan X, Lin Z, Chen J, Luo L, Wu X, Long E, Chen W, Liu Y. Capsular Outcomes Differ with Capsulorhexis Sizes after Pediatric Cataract Surgery: A Randomized Controlled Trial. Sci Rep. 2015 Nov 5;5:16227. doi: 10.1038/srep16227.
citation: Tan X, Lin H, Lin Z, Chen J, Tang X, Luo L, Chen W, Liu Y. Capsular Outcomes After Pediatric Cataract Surgery Without Intraocular Lens Implantation: Qualitative Classification and Quantitative Measurement. Medicine (Baltimore). 2016 Mar;95(10):e2993. doi: 10.1097/MD.0000000000002993.
citation: Fu Y, Wang D, Ding X, Chang P, Zhao Y, Hu M, Li Z, Zhao YE. Posterior Capsular Outcomes of Pediatric Cataract Surgery With In-The-Bag Intraocular Lens Implantation. Front Pediatr. 2022 Apr 8;10:827084. doi: 10.3389/fped.2022.827084. eCollection 2022.