Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

• Conditions: Pediatric Cataract

• Registration Number: NCT04357249
• Lead Sponsor: Wenzhou Medical University

Brief Summary

The aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. The investigators included children with cataract planning to have cataract surgery in our institute. Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. The investigators recorded age at surgery, gender and relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.All patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. Patients were followed for two years or until the development of severe VAO requiring Nd: YAG laser capsulotomy, whichever came first. The examinations consisted of visual acuity, IOP measurement by a Tonopen tonometer (Reichert, Inc., Seefeld, Germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).The primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.A paired T test was used to compare the areas of the PCO between the postoperative visits and baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22
• Primary Completion: 2020-07-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants included eyes of children with unilateral or bilateral cataract.

Exclusion Criteria

Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis, or surgical complications, as well as those whose pupils could not dilate normally postoperation or who could not complete the follow-up, were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
area of PCO	2015.5.1- 2020.8-1	area of posterior capsular opening

Trial Locations

Locations (1)

Wenzhou Medical Colledge; 🇨🇳 Wenzhou, Zhejiang, China