Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery

NCT ID: NCT04521907

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

177 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-01

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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The Incidence and Risk Factors of Glaucoma After Congenital Cataract Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Group 1 includes patients who underwent cataract surgery with primary IOL implantation

No interventions assigned to this group

Group 2

Group 2 includes patients who underwent cataract surgery with secondly IOL implantation

No interventions assigned to this group

Group 3

Group 3 includes patients who underwent cataract surgery without IOL implantation.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zuhui zhang

Role: CONTACT

+86 15268840754

Facility Contacts

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zhao yun-e

Role: primary

+86 13819707056

Other Identifiers

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GRAE2 -zzh

Identifier Type: -

Identifier Source: org_study_id

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