Glaucoma After Congenital And Infantile Cataract Surgery

NCT ID: NCT04131114

Last Updated: 2020-04-09

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

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2021-12-31

Brief Summary

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Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.

Detailed Description

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A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.

Conditions

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Glaucoma Congenital Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* a diagnosis of congenital/infantile cataracts without any surgical intervention;
* age younger than 10 years;
* cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment

Exclusion Criteria

* a preoperative IOP above 21 mm Hg;
* the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
* the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haotian Lin, Ph.D

Role: CONTACT

+86-020-87333271

Facility Contacts

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Jinghui Wang, Ph.D

Role: primary

+86-020-87333271

Other Identifiers

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CCPMOH2016-China-0303

Identifier Type: -

Identifier Source: org_study_id

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