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

Pediatric Cataract Clinical Trial

— Capsular  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04357249
• Other study ID #: FYN-capsular
• Status: Recruiting
• Start date: March 1, 2015
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2020
• Source: Wenzhou Medical University
• Contact: FU YANA, MD
• Phone: +8613003605152
• Email: 27771310[@]QQ.COM
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Pediatric Cataract

Locations

Country	Name	City	State
China	Wenzhou Medical Colledge	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area of PCO	area of posterior capsular opening	2015.5.1- 2020.8-1