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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04521907
Other study ID # GRAE2 -zzh
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2011
Est. completion date October 1, 2020

Study information

Verified date August 2020
Source Wenzhou Medical University
Contact Zuhui zhang
Phone +86 15268840754
Email zhzhangeye@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. We recorded patient demographics and incidence and risk factors for glaucoma-related adverse event. This study to identify the incidence of and risk factors associated with postoperative glaucoma at various durations after congenital cataract surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 177
Est. completion date October 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers
Gender All
Age group 1 Month to 14 Years
Eligibility Inclusion Criteria:

- Patients who underwent lensectomy combined with limited anterior vitrectomy, with or without IOL implantation for congenital cataract, all by one surgeon

Exclusion Criteria:

- Patient had a preoperative IOP above 21mmHg, glaucoma, coexistent uveitis, metabolic syndromes/diseases or exposure to radiation.

Study Design


Related Conditions & MeSH terms

  • Cataract
  • Glaucoma
  • The Incidence and Risk Factors of Glaucoma After Congenital Cataract Surgery

Locations

Country Name City State
China Ophthalmology and Optometry Hospital 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 Incidence of glaucoma after congenital cataract surgery The incidence of glaucoma at various durations after congenital cataract surgery 2020.6.30
Primary Demographic data, including sex, age at surgery, gestational history, family history of cataract, and laterality of disease, were collected. Risk factors 2020.6.30