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

NCT04357249 | Unknown

• 1 other identifier: FYN-capsular
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cataract

Outcome Measures

Primary Outcomes (1)

• area of PCO

  area of posterior capsular opening

  2015.5.1- 2020.8-1

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants included eyes of children with unilateral or bilateral cataract.

You may qualify if:

• Participants included eyes of children with unilateral or bilateral cataract.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Wenzhou Medical Colledge

Wenzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• ZHAO YUNE, MD

  executive dean

  STUDY DIRECTOR

Central Study Contacts

FU YANA, MD

CONTACT

+8613003605152; 27771310@QQ.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: yin ying zhao [yyzhao]

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: March 1, 2015
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

CN (1)